Ozurdex
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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 

 



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1. NAME OF THE MEDICINAL PRODUCT 
 
OZURDEX 700 micrograms intravitreal implant in applicator 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
One implant contains 700 micrograms of dexamethasone. 
 
For the full list of excipients, see section 6.1. 
 
3. PHARMACEUTICAL FORM 
 
Intravitreal implant in applicator.  
 
Disposable injection device, containing a rod-shaped implant. which is not visible. The implant is 
approximately 0.46 mm in diameter and 6 mm in length. 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
OZURDEX is indicated for the treatment of adult patients with: 

• visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are 
considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy  

• macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal 
Vein Occlusion (CRVO) (see section 5.1)  

• inflammation of the posterior segment of the eye presenting as non-infectious uveitis 
  
4.2 Posology and method of administration 
 
OZURDEX must be administered by a qualified ophthalmologist experienced in intravitreal injections. 
 
Posology 
The recommended dose is one OZURDEX implant to be administered intra-vitreally to the affected 
eye. Administration to both eyes concurrently is not recommended (see section 4.4). 
 
DME 
Patients treated with OZURDEX who have experienced an initial response and in the physician’s 
opinion may benefit from retreatment without being exposed to significant risk should be considered 
for retreatment.  
 
Retreatment may be performed after approximately 6 months if the patient experiences decreased 
vision and/or an increase in retinal thickness, secondary to recurrent or worsening diabetic macular 
oedema.  
 
There is currently no experience of the efficacy or safety of repeat administrations in DME beyond 
7 implants. 
 
RVO and uveitis 
Repeat doses should be considered when a patient experiences a response to treatment followed 
subsequently by a loss in visual acuity and in the physician’s opinion may benefit from retreatment 
without being exposed to significant risk (see section 5.1).   
 
Patients who experience and retain improved vision should not be retreated. Patients who experience 
deterioration in vision, which is not slowed by OZURDEX, should not be retreated. 
 



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There is only very limited information on repeat dosing intervals less than 6 months (see section 5.1).  
 
For information concerning the current safety experience of repeat administrations beyond 2 implants 
in posterior segment non-infectious uveitis  and Retinal Vein Occlusion, see section 4.8. 
 
Patients should be monitored following the injection to permit early treatment if an infection or 
increased intraocular pressure occurs (see section 4.4). 
 
Special populations 
 
Elderly (≥65 years old) 
No dose adjustment is required for elderly patients. 
 
Renal impairment 
OZURDEX has not been studied in patients with renal impairment however no special considerations 
are needed in this population.  
 
Hepatic impairment 
OZURDEX has not been studied in patients with hepatic impairment; however no special 
considerations are needed in this population.  
 
Paediatric population  
There is no relevant use of OZURDEX in the paediatric population in 

• diabetic macular oedema  
• macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal 

Vein Occlusion (CRVO) 
 
The safety and efficacy of OZURDEX in uveitis in the paediatric population have not been 
established. No data are available. 
 
Method of administration 
OZURDEX is a single-use intravitreal implant in applicator for intravitreal use only. 
Each applicator can only be used for the treatment of a single eye. 
 
The intravitreal injection procedure should be carried out under controlled aseptic conditions which 
include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). 
 
The patient should be instructed to self-administer broad spectrum antimicrobial drops daily for 3 days 
before and after each injection. Before the injection, the periocular skin, eyelid and ocular surface 
should be disinfected (using for example drops of povidone iodine 5% solution on the conjunctiva as it 
was done in the clinical trials for the approval of OZURDEX) and adequate local anaesthesia should 
be administered.  Remove the foil pouch from the carton and examine for damage (see section 6.6). 
Then, in a sterile field, open the foil pouch and gently place the applicator on a sterile tray. Carefully 
remove the cap from the applicator. Once the foil pouch is opened the applicator should be used 
immediately. Hold the applicator in one hand and pull the safety tab straight off the applicator. Do not 
twist or flex the tab. With the bevel of the needle up away from the sclera, advance the needle about 
1 mm into the sclera then redirect toward the centre of the eye into the vitreous cavity until the silicone 
sleeve is against the conjunctiva. Slowly press the actuator button until an audible click is noted. 
Before withdrawing the applicator from the eye, make sure that the actuator button is fully pressed and 
has locked flush with the applicator surface. Remove the needle in the same direction as used to enter 
the vitreous. 
 
For instructions on the administration of the intravitreal implant, see section 6.6 
 
Immediately after injecting OZURDEX, use indirect ophthalmoscopy in the quadrant of injection to 
confirm successful implantation. Visualisation is possible in the large majority of cases.  In cases in 



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which the implant cannot be visualised, take a sterile cotton bud and lightly depress over the injection 
site to bring the implant into view.  
 
Following the intravitreal injection patients should continue to be treated with a broad spectrum 
antimicrobial.  
 
 
4.3 Contraindications 
 
• Hypersensitivity to the active substance or to any of the excipients as listed in section 6.1.  
• Active or suspected ocular or periocular infection including most viral diseases of the cornea 

and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), 
vaccinia, varicella, mycobacterial infections, and fungal diseases. 

• Advanced glaucoma which cannot be adequately controlled by medicinal products alone. 
• Aphakic eyes with ruptured posterior lens capsule. 
• Eyes with Anterior Chamber Intraocular Lens (ACIOL), iris or transscleral fixated intraocular 

lens and ruptured posterior lens capsule. 
 
4.4 Special warnings and precautions for use 
 
Intravitreous injections, including those with OZURDEX, can be associated with endophthalmitis, 
intraocular inflammation, increased intraocular pressure and retinal detachment. Proper aseptic 
injection techniques must always be used. In addition, patients should be monitored following the 
injection to permit early treatment if an infection or increased intraocular pressure occurs. Monitoring 
may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry 
within 30 minutes following the injection, and biomicroscopy between two and seven days following 
the injection.  
 
Patients must be instructed to report any symptoms suggestive of endophthalmitis or any of the above 
mentioned events without delay, e.g. eye pain, blurred vision etc. (see section 4.8).  
 
All patients with posterior capsule tear, such as those with a posterior lens (e.g. due to cataract 
surgery), and/or those who have an iris opening to the vitreous cavity (e.g. due to iridectomy) with or 
without a history of vitrectomy, are at risk of implant migration into the anterior chamber. Implant 
migration to the anterior chamber may lead to corneal oedema.  Persistent severe corneal oedema 
could progress to the need for corneal transplantation.  Other than those patients contraindicated (see 
section 4.3) where OZURDEX should not be used, OZURDEX should be used with caution and only 
following a careful risk benefit assessment. These patients should be closely monitored to allow for 
early diagnosis and management of device migration.  
 
Use of corticosteroids, including OZURDEX, may induce cataracts (including posterior subcapsular 
cataracts), increased IOP, steroid induced glaucoma and may result in secondary ocular infections.  
 
In the 3 year DME clinical studies, 59% of patients with a phakic study eye treated with OZURDEX 
underwent cataract surgery in the study eye (see section 4.8).   
 
After the first injection the incidence of cataract appears higher in patients with non-infectious uveitis 
of the posterior segment compared with BRVO/CRVO patients. In BRVO/CRVO clinical studies, 
cataract was reported more frequently in patients with phakic lens receiving a second injection (see 
section 4.8). Only 1 patient out of 368 required cataract surgery during the first treatment and 
3 patients out of 302 during the second treatment. In the non-infectious uveitis study, 1 patient out of 
the 62 phakic patients underwent cataract surgery after a single injection.   
 
The prevalence of conjunctival haemorrhage in patients with non-infectious uveitis of the posterior 
segment appears to be higher compared with BRVO/CRVO and DME.   This could be attributable to 
the intravitreous injection procedure or to concomitant use of topical and/or systemic corticosteroid or 



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Non-steroidal anti-inflammatory medications.  No treatment is required since spontaneous resolution 
occurs. 
 
As expected with ocular steroid treatment and intravitreal injections, increases in intraocular pressure 
(IOP) may be seen. The rise in IOP  is normally manageable with IOP lowering medication (see 
section 4.8).  Of the patients experiencing an increase of IOP of ≥10 mmHg from baseline, the greatest 
proportion showed this IOP increase between 45 and 60 days following an injection.  Therefore, 
regular monitoring of IOP, irrespective of baseline IOP, is required and any elevation should be 
managed appropriately post-injection as needed.   Patients of less than 45 years of age with macular 
oedema following Retinal Vein Occlusion or inflammation of the posterior segment of the eye 
presenting as non-infectious uveitis are more likely to experience increases in IOP.   
 
Corticosteroids should be used cautiously in patients with a history of ocular viral (e.g. herpes 
simplex) infection and not be used in active ocular herpes simplex. 
 
The safety and efficacy of OZURDEX administered to both eyes concurrently have not been studied. 
Therefore administration to both eyes concurrently is not recommended.  
 
OZURDEX has not been studied in patients with macular oedema secondary to RVO with significant 
retinal ischemia. Therefore OZURDEX is not recommended. 
 
A limited number of subjects with Type 1 diabetes were investigated in the Phase 3 studies, and the 
response to OZURDEX in these subjects was not significantly different to those subjects with Type 2 
diabetes.   
 
In RVO, anti-coagulant therapy was used in 2% of patients receiving OZURDEX; there were no 
reports of haemorrhagic adverse events in these patients.  In DME, anti-coagulant therapy was used in 
8% of patients.  Among patients who used anti-coagulant therapy, the frequency of haemorrhagic 
adverse events was similar in the OZURDEX and sham groups (29% vs 32%).  Among patients who 
did not use anti-coagulant therapy, 27% of OZURDEX treated patients reported haemorrhagic adverse 
events compared to 20% in the sham group.  Vitreous haemorrhage was reported in a higher 
proportion of patients treated with OZURDEX who received anti-coagulant therapy (11%) compared 
with those not receiving anticoagulant therapy (6%).  
 
Anti-platelet medicinal products, such as clopidogrel, were used at some stage during the clinical 
studies in up to 56% of patients.  For patients using concomitant and anti-platelet medication, 
haemorrhagic adverse events were reported in a slightly higher proportion of patients injected with 
OZURDEX (up to 29%) compared with the sham group (up to 23%), irrespective of indication or 
number of treatments.  The most common haemorrhagic adverse event reported was conjunctival 
haemorrhage (up to 24%).   
 
OZURDEX should be used with caution in patients taking anti-coagulant or anti-platelet medicinal 
products.  
 
Visual disturbance 
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents 
with symptoms such as blurred vision or other visual disturbances, consider evaluating for possible 
causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy 
(CSCR) which have been reported after use of systemic and topical corticosteroids. 
 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed.  
Systemic absorption is minimal and no interactions are anticipated. 
 



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4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
Studies in animals have shown teratogenic effects following topical ophthalmic administration (see 
section 5.3). There are no adequate data from the use of intravitreally administered dexamethasone in 
pregnant women. Long-term systemic treatment with glucocorticoids during pregnancy increases the 
risk for intra-uterine growth retardation and adrenal insufficiency of the newborn child. Therefore, 
although the systemic exposure of dexamethasone would be expected to be very low after local, 
intraocular treatment, OZURDEX is not recommended during pregnancy unless the potential benefit 
justifies the potential risk to the foetus. 
 
Breast-feeding 
Dexamethasone is excreted in breast milk  No effects on the child are anticipated due to the route of 
administration and the resulting systemic levels. However OZURDEX is not recommended during 
breast feeding unless clearly necessary.  
 
Fertility 
There are no fertility data available. 
 
4.7 Effects on ability to drive and use machines 
 
OZURDEX may have a moderate influence on the ability to drive and use machines.  Patients may 
experience temporarily reduced vision after receiving OZURDEX by intravitreal injection (see 
section 4.8). They should not drive or use machines until this has resolved. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The most commonly-reported adverse events reported following treatment with OZURDEX are those 
frequently observed with ophthalmic steroid treatment or intravitreal injections (elevated IOP, cataract 
formation and conjunctival or vitreal haemorrhage respectively). 
 
Less frequently reported, but more serious, adverse reactions include endophthalmitis, necrotizing 
retinitis, retinal detachment and retinal tear. 
 
With the exception of headache and migraine, no systemic adverse drug reactions were identified with 
the use of OZURDEX. 
 
Tabulated list of adverse reactions  
The adverse reactions considered related to OZURDEX treatment from the Phase III clinical trials 
(DME, BRVO/CRVO and uveitis) and spontaneous reporting are listed by MedDRA System organ 
class in the table below using the following convention:  
 
Very common (≥ 1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 
to <1/1,000); very rare (<1/10,000).  Within each frequency grouping, adverse reactions are presented 
in order of decreasing seriousness. 
 



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Table 1     Adverse reactions 
 
System organ class Frequency Adverse reaction 
Nervous system disorders Common Headache 
 Uncommon Migraine 
Eye disorders Very common Intraocular pressure increased**, cataract**, 

conjunctival haemorrhage*  
 Common Ocular hypertension, cataract subcapsular, vitreous 

haemorrhage**, visual acuity reduced*, visual 
impairment/ disturbance, vitreous detachment*, 
vitreous floaters*, vitreous opacities*, blepharitis,  
eye pain*, photopsia*, conjunctival oedema* 
conjunctival hyperaemia* 

 Uncommon Necrotizing retinitis, endophthalmitis*, glaucoma, 
retinal detachment*, retinal tear*, hypotony of the 
eye*, anterior chamber inflammation*, anterior 
chamber cells/ flares*, abnormal sensation in eye*, 
eyelids pruritus,  scleral hyperaemia* 

General disorders and 
administration site 
conditions 

Uncommon Device dislocation* (migration of implant) with or 
without corneal oedema (see also section 4.4), 
complication of device insertion resulting in ocular 
tissue injury* (implant misplacement) 

 
* indicates adverse reactions considered to be related to the intravitreal injection procedure (the frequency of 
these adverse reactions is proportional to the number of treatments given). 
** in a 24-month real world observational study in the treatment of macular oedema following RVO and non-
infectious uveitis affecting the posterior segment of the eye these adverse events were reported more frequently 
among patients who received >2 injections vs patients who received ≤2 injections; cataract formation (24.7% vs 
17.7%), cataract progression (32.0% vs 13.1%), vitreous haemorrhage (6.0% vs 2.0%), and increased IOP 
(24.0% vs 16.6%). 
 
 
Description of selected adverse reactions  
Diabetic Macular Oedema 
 
The clinical safety of OZURDEX in patients with diabetic macular oedema was assessed in two 
phase 3 randomized, double-masked, sham-controlled studies. In both studies, a total of 347 patients 
were randomized and received OZURDEX and 350 patients received sham. 
 
The most frequently reported adverse reactions across the entire study period in the study eye of 
patients who received OZURDEX were cataract and elevated IOP (see below).  
 
In the 3 year DME clinical studies, at baseline, 87% of patients with a phakic study eye treated with 
OZURDEX had some degree of lens opacification/ early cataract.  The incidence of all observed 
cataract types (i.e. cataract cortical, cataract diabetic, cataract nuclear, cataract subcapsular, cataract 
lenticular, cataract) was 68% in OZURDEX treated patients with a phakic study eye across the 3 year 
studies.  59% of patients with a phakic study eye required cataract surgery by the 3 year final visit, 
with the majority performed in the 2nd and 3rd years.  
 
Mean IOP in the study eye at baseline was the same in both treatment groups (15.3 mmHg).  The 
mean increase from baseline IOP did not exceed 3.2 mmHg across all visits in the OZURDEX group 
with the mean IOP peaking at the 1.5 month visit post injection, and returning to approximately 
baseline levels by month 6 following each injection.  The rate and magnitude of IOP elevation 
following OZURDEX treatment did not increase upon repeated injection of OZURDEX.  
 
28% of patients treated with OZURDEX had a ≥ 10 mm Hg IOP increase from baseline at one or more 



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visits during the study.  At baseline 3% of patients required IOP-lowering medication(s).  Overall, 
42% of patients required IOP-lowering medications in the study eye at some stage during the 3 year 
studies, with the majority of these patients requiring more than one medication.  Peak usage (33%) 
occurred during the first 12 months and remained similar from year to year.   
 
A total of 4 patients (1%) treated with OZURDEX had procedures in the study eye for the treatment of 
IOP elevation.  One patient treated with OZURDEX required incisional surgery (trabeculectomy) to 
manage the steroid-induced IOP elevation, 1 patient had a trabeculectomy owing to anterior chamber 
fibrin blocking the aqueous outflow leading to increased IOP, 1 patient had an iridotomy for narrow 
angle glaucoma and 1 patient had iridectomy due to cataract surgery.  No patient required removal of 
the implant by vitrectomy to control IOP. 
 
BRVO/CRVO 
The clinical safety of OZURDEX in patients with macular oedema following central or branch retinal 
vein occlusion has been assessed in two Phase III randomised, double-masked, sham-controlled 
studies. A total of 427 patients were randomised to receive OZURDEX and 426 to receive sham in the 
two Phase III studies. A total of 401 patients (94 %) randomised and treated with OZURDEX 
completed the initial treatment period (up to day 180).  
 
A total of 47.3 % of patients experienced at least one adverse reaction. The most frequently reported 
adverse reactions in patients who received OZURDEX were increased intraocular pressure (24.0 %) 
and conjunctival haemorrhage (14.7 %). 
 
The adverse reaction profile for BRVO patients was similar to that observed for CRVO patients 
although the overall incidence of adverse reactions was higher for the subgroup of patients with 
CRVO. 
 
Increased intraocular pressure (IOP) with OZURDEX peaked at day 60 and returned to baseline levels 
by day 180.  Elevations of IOP either did not require treatment or were managed with the temporary 
use of topical IOP-lowering medicinal products. During the initial treatment period, 0.7 %  (3/421) of 
the patients who received OZURDEX required laser or surgical procedures for management of 
elevated IOP in the study eye compared with 0.2 % (1/423) with sham.   
 
The adverse reaction profile of 341 patients analysed following a second injection of OZURDEX, was 
similar to that following the first injection. A total of 54 % of patients experienced at least one adverse 
reaction.  The incidence of increased IOP (24.9 %) was similar to that seen following the first injection 
and likewise returned to baseline by open-label day 180. The overall incidence of cataracts was higher 
after 1 year compared to the initial 6 months. 
 
 
Uveitis 
The clinical safety of OZURDEX in patients with inflammation of the posterior segment of the eye 
presenting as non-infectious uveitis, has been assessed in a single, multicentre, masked, randomised 
study. 
 
A total of 77 patients were randomised to receive OZURDEX and 76 to receive Sham. A total of 
73 patients (95%) randomised and treated with OZURDEX completed the 26-week study. 
 
The most frequently reported adverse reactions in the study eye of patients who received OZURDEX 
were conjunctival haemorrhage (30.3%), increased intraocular pressure (25.0%) and cataract (11.8%). 
 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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4.9 Overdose 
 
If an overdose occurs, intraocular pressure should be monitored and treated, if deemed 
necessary by the attending physician. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Ophthalmologicals, antiinflammatory agents, ATC code: S01BA01  
 
Dexamethasone, a potent corticosteroid, has been shown to suppress inflammation by inhibiting 
oedema, fibrin deposition, capillary leakage, and phagocytic migration of the inflammatory 
response. Vascular Endothelial Growth Factor (VEGF) is a cytokine which is expressed at increased 
concentrations in the setting of macular oedema.  It is a potent promoter of vascular permeability.  
Corticosteroids have been shown to inhibit the expression of VEGF. Additionally, corticosteroids 
prevent the release of prostaglandins, some of which have been identified as mediators of cystoid 
macular oedema. 
 
Clinical efficacy and safety 
Diabetic Macular Oedema 
 
The efficacy of OZURDEX was assessed in two 3 year, multicentre, double-masked, randomised, 
sham-controlled, parallel studies of identical design which together comprised 1,048 patients 
(studies 206207-010 and 206207-011).  A total of 351 were randomised to OZURDEX, 347 to 
dexamethasone 350 µg and 350 patients to sham.  
 
Patients were eligible for retreatment based upon central subfield retinal thickness >175 microns by 
optical coherence tomography (OCT) or upon investigators interpretation of the OCT for any 
evidence of residual retinal edema consisting of intraretinal cysts or any regions of increased retinal 
thickening within or outside of the central subfield.  Patients received up to 7 treatments at intervals 
no more frequently than approximately every 6 months.   
 
Escape therapy was permitted at the investigators discretion at any stage but led to subsequent 
withdrawal from the studies.    
 
A total of 36% of OZURDEX treated patients discontinued study participation for any reason during 
the study compared with 57% of sham patients.  Discontinuation rates due to adverse events were 
similar across treatment and sham groups (13% vs 11%).  Discontinuation due to lack of efficacy 
was lower in the OZURDEX group compared to sham (7% vs 24%).   
 
The primary and key secondary endpoints for studies 206207-010 and 011 are presented in Table 2.  
The vision improvement in the DEX700 group was confounded by cataract formation.  Vision 
improvement was re-established upon removal of cataract. 
 



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Table 2.  Efficacy in studies 206207-010 and 206207-011 (ITT population) 
 
 
 
 
 
Endpoint 

Study  
206207-010 

Study  
206207-011 

Pooled Studies 
206207-010 and 

206207-011 
DEX 
700 

N = 163 

Sham 
 

N = 165 

DEX 
700 

N = 188 

Sham 
 

N = 185 

DEX 
700 

N = 351 

Sham 
 

N = 350 
Mean BCVA average change over 
3 years, AUC approach (letters) 4.1 1.9 2.9 2.0 3.5 2.0 

P-value 0.016 0.366 0.023 

BCVA ≥ 15-letter improvement 
from baseline at Year 3/Final (%) 22.1 13.3 22.3 10.8 22.2 12.0 

P-value 0.038 0.003 < 0.001 

Mean BCVA change from baseline 
at year 3/final visit (letters) 4.1 0.8 1.3 -0.0 2.6 0.4 

P-value 0.020 0.505 0.054 

OCT retinal thickness at center 
subfield mean average change over 
3 years, AUC approach (µm) 

-101.1 -37.8 -120.7 -45.8  -111.6 -41.9 

P-value <0.001 < 0.001 < 0.001 

 
The primary and key secondary endpoints for the pooled analysis for pseudophakic patients are 
presented in Table 3.   
 
Table 3.  Efficacy in pseudophakic patients (pooled studies 206207-010 and 206207-011) 
 
Endpoint 

DEX 700 
N = 86 

Sham 
N = 101 

 
P-value 

Mean BCVA average change over 3 years, AUC 
approach (letters) 

6.5 1.7 < 0.001 

BCVA ≥ 15-letter improvement from baseline at 
Year 3/Final visit (%) 

23.3 10.9 0.024 

Mean BCVA change from baseline at year 3/Final visit 6.1 1.1 0.004 
OCT retinal thickness at center subfield mean average 
change over 3 years, AUC approach (µm) 

-131.8 -50.8 < 0.001 

 
 
The primary and key secondary endpoints for the pooled analysis for patients with any prior 
treatment are presented in Table 4.   



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Table 4.  Efficacy in patients with any prior treatment (pooled studies 206207-010 and 206207-
011) 
 
Endpoint 

DEX 700 
N = 247 

Sham 
N = 261 

 
P-value 

Mean BCVA average change over 3 years, AUC 
approach (letters) 3.2 1.5 0.024 

BCVA ≥ 15-letter improvement from baseline at 
Year 3/Final visit (%) 21.5 11.1 0.002 

Mean BCVA change from baseline at year 3/Final 
visit 2.7 0.1 0.055 

OCT retinal thickness at center subfield mean average 
change over 3 years, AUC approach (µm) -126.1 -39.0 < 0.001 

 
 
BRVO/CRVO 
The efficacy of OZURDEX was assessed in two multicentre, double-masked, randomised, 
sham-controlled, parallel studies of identical design which together comprised 1,267 patients who 
were randomized to receive treatment with dexamethasone 350 µg or 700 µg implants or sham 
(studies 206207-008 and 206207-009).  A total of 427 were randomised to OZURDEX, 414 to 
dexamethasone 350 µg and 426 patients to sham. 
 
Based on the pooled analysis results, treatment with OZURDEX implants showed statistically 
significantly greater incidence of responders, defined as patients achieving a ≥ 15 letter 
improvement from baseline in Best Corrected Visual Acuity (BCVA) at 90 days following injection 
of a single implant, when compared with sham (p < 0.001). 
 
The proportion of patients achieving the primary efficacy measure of ≥ 15 letter improvement from 
baseline in BCVA following injection of a single implant is shown in Table 5. A treatment effect was 
seen at the first observation time point of day 30.  The maximum treatment effect was observed at 
day 60 and the difference in the incidence of responders was statistically significant favouring 
OZURDEX compared with sham at all time points to day 90 following injection. There continued to 
be a numerically greater proportion of responders for a ≥ 15 letter improvement from baseline in 
BCVA in patients treated with OZURDEX compared with sham at day 180.  
 
Table 5.  Proportion of patients with ≥ 15 letters improvement from  
  baseline best corrected visual acuity in the study eye  
  (pooled, ITT population) 
 

 OZURDEX Sham 
Visit N = 427  N = 426 

Day 30 21.3 % a 7.5% 
Day 60 29.3% a 11.3% 
Day 90 21.8% a 13.1% 
Day 180                 21.5% 17.6% 

a Proportion significantly higher with OZURDEX compared to sham (p < 0.001) 
 
The mean change from baseline BCVA was significantly greater with OZURDEX compared to sham 
at all time points.  
 
In each Phase III study and the pooled analysis, the time to achieve ≥ 15 letters (3-line) improvement 
in BCVA cumulative response curves were significantly different with OZURDEX compared to sham 
(p < 0.001) with OZURDEX treated patients achieving a 3-line improvement in BCVA earlier than 
sham treated patients. 
 



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OZURDEX was numerically superior to sham in preventing vision loss as shown by a lower of 
proportion of patients experiencing deterioration of vision of ≥ 15 letters in the OZURDEX group 
throughout the 6-month assessment period.  
 
In each of the phase III studies and the pooled analysis, mean retinal thickness was significantly less, 
and the mean reduction from baseline was significantly greater, with OZURDEX  (-207.9 microns) 
compared to sham (-95.0 microns) at day 90 (p < 0.001, pooled data). The treatment effect as assessed 
by BCVA at day 90 was thus supported by this anatomical finding.  By Day 180 the mean retinal 
thickness reduction (-119.3 microns) compared with sham was not significant.    
 
Patients who had a BCVA score of <84 OR retinal thickness > 250 microns by optical coherence 
tomography OCT and in the investigator’s opinion treatment would not put the patient at risk; were 
eligible to receive an OZURDEX treatment in an open label extension.  Of the patients who were 
treated in the open label phase, 98% received an OZURDEX injection between 5 and 7 months after 
the initial treatment. 
 
As for the initial treatment, peak response was seen at Day 60 in the open label phase. The cumulative 
response rates were higher throughout the open label phase in those patients receiving two consecutive 
OZURDEX injections compared with those patients who had not received an OZURDEX injection in 
the initial phase. 
 
The proportion of responders at each time point was always greater after the second treatment 
compared with the first treatment.  Whereas, delaying treatment for 6 months results in a lower 
proportion of responders at all time points in the open label phase when compared with those receiving 
a second OZURDEX injection. 
 
Uveitis 
The clinical efficacy of OZURDEX has been assessed in a single, multicentre, masked, randomised 
study for the treatment of non-infectious ocular inflammation of the posterior segment in patients with 
uveitis. 
 
A total of 229 patients were randomised to receive dexamethasone 350 µg or 700 µg implants or 
sham.  Of these, a total of 77 were randomised to receive OZURDEX, 76 to dexamethasone 350 µg 
and 76 to sham.  A total of 95% of patients completed the 26-week study. 
 
The proportion of patients with vitreous haze score of 0 in the study eye at week 8 (primary endpoint) 
was 4-fold higher with OZURDEX (46.8%) compared to Sham (11.8%), p < 0.001. Statistical 
superiority was maintained up to and including week 26 (p ≤ 0.014) as shown in Table 6. 
 
The cumulative response rate curves (time to vitreous haze score of 0) were significantly different for 
the OZURDEX group compared to the Sham group (p < 0.001), with patients receiving 
dexamethasone showing an earlier onset and greater treatment response. 
 
The reduction in vitreous haze was accompanied by an improvement in visual acuity. The 
proportion of patients with at least 15 letters improvement from baseline BCVA in the 
study eye at week 8 was more than 6-fold higher with OZURDEX (42.9%) compared to 
Sham (6.6%), p < 0.001. Statistical superiority was achieved at week 3 and maintained up to and 
including week 26 (p < 0.001) as shown in Table 6. 
 
The percent of patients requiring escape medications from baseline to week 8 was nearly 3-fold less 
with OZURDEX (7.8%) compared to Sham (22.4%), p = 0.012. 
 



13 

Table 6.  Proportion of patients with vitreous haze score of zero and ≥ 15 letters improvement 
from baseline best corrected visual acuity in the study eye (ITT population) 

 
Visit Vitreous Haze Score of Zero BCVA improvement from baseline 

of ≥15 letters 
 DEX 700 

N = 77 
Sham 
N = 76 

DEX 700 
N = 77 

Sham 
N = 76 

Week 3 23.4% 11.8% 32.5%a 3.9% 
Week 6 42.9%a 9.2% 41.6%a 7.9% 
Week 8 46.8%a 11.8% 42.9%a 6.6% 

Week 12 45.5%a 13.2% 41.6%a 13.2% 
Week 16 40.3%b 21.1% 39.0%a 13.2% 
Week 20 39.0%c 19.7% 40.3%a 13.2% 
Week 26 31.2%d 14.5% 37.7%a 13.2% 

a  p < 0.001;  b p = 0.010;  c p = 0.009;  d p = 0.014 
 
Paediatric population 
 
The European Medicines Agency has waived the obligation to submit the results of studies with 
OZURDEX in all subsets of the paediatric population for retinal vascular occlusion and also for 
diabetic macular oedema (see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
Plasma concentrations were obtained from a subset of 21 patients in the two RVO, 6-month efficacy 
studies prior to dosing and on days 7, 30, 60 and 90 following intravitreal injection of a single 
intravitreal implant containing 350 µg or 700 µg dexamethasone.  Ninety-five percent of the plasma 
dexamethasone concentration values for the 350 µg dose group and 86% for the 700 µg dose group 
were below the lower limit of quantitation (0.05 ng/mL). The highest plasma concentration value of 
0.094 ng/mL was observed in one subject from the 700 µg group. Plasma dexamethasone 
concentration did not appear to be related to age, body weight, or sex of patients. 
 
Plasma concentrations were obtained from a subgroup of patients in the two DME pivotal studies prior 
to dosing and on days  1, 7, and 21, and months 1.5 and 3 following intravitreal injection of a single 
intravitreal implant containing 350 µg or 700 µg dexamethasone.  One hundred percent of the plasma 
dexamethasone concentration values for the 350 µg dose group and 90% for the 700 µg dose group 
were below the lower limit of quantitation (0.05 ng/mL).  The highest plasma concentration value of 
0.102 ng/mL was observed in 1 subject from the 700 µg group.  Plasma dexamethasone concentration 
did not appear to be related to age, body weight, or sex of patients.  
 
In a 6-month monkey study following a single intravitreal injection of OZURDEX the dexamethasone 
vitreous humour Cmax was 100 ng/mL at day 42 post-injection and 5.57 ng/mL at day 91. 
Dexamethasone remained detectable in the vitreous at 6 months post-injection. The rank order of 
dexamethasone concentration was retina > iris > ciliary body > vitreous humour > aqueous humour > 
plasma.  
 
In an in vitro metabolism study, following the incubation of [14C]-dexamethasone with human cornea, 
iris-ciliary body, choroid, retina, vitreous humour, and sclera tissues for 18 hours, no metabolites were 
observed. This is consistent with results from rabbit and monkey ocular metabolism studies.  
 
Dexamethasone is ultimately metabolised to lipid and water soluble metabolites that can be excreted in 
bile and urine. 
 
The OZURDEX matrix slowly degrades to lactic acid and glycolic acid through simple hydrolysis, 
then further degrades into carbon dioxide and water. 
 



14 

5.3 Preclinical safety data  
 
Effects in non-clinical studies were observed only at doses considered sufficiently in excess of the 
maximum dose for human indicating little relevance to clinical use. 
 
No mutagenicity, carcinogenicity, reproductive or developmental toxicity data are available for 
OZURDEX. Dexamethasone has been shown to be teratogenic in mice and rabbits following topical 
ophthalmic application. 
 
Dexamethasone exposure to the healthy/untreated eye via contralateral diffusion has been observed in 
rabbits following delivery of the implant to the posterior segment of the eye. 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Ester terminated 50:50 poly D,L-lactide-co-glycolide. 
Acid terminated 50:50 poly D,L-lactide-co-glycolide. 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
3 years. 
 
6.4 Special precautions for storage 
 
This medicinal product does not require any special storage conditions.  
 
6.5 Nature and contents of container 
 
Each pack contains: 
 
One sustained release sterile implantable rod shaped implant containing 700 micrograms of 
dexamethasone, located in the needle (stainless steel) of a disposable applicator.  
 
The applicator consists of a plunger (stainless steel) within a needle where the implant is held in place 
by a sleeve (silicone). The plunger is controlled by a lever on the side of the applicator body. The 
needle is protected by a cap and the lever by a safety tab.  
 
The applicator containing the implant is packaged in a sealed foil pouch containing desiccant. 
 
6.6 Special precautions for disposal  and other handling 
 
OZURDEX is for single use only. 
Each applicator can only be used for the treatment of a single eye.  
 
If the seal of the foil pouch containing the applicator is damaged, the applicator must not be used. 
Once the foil pouch is opened the applicator should be used immediately. 
 
Administering OZURDEX  
 



15 

1) Hold the long axis of the applicator parallel to the limbus.  
 

 
 

2) Allow the applicator to meet the sclera at an oblique angle with 
the bevel of the needle facing up, away from the sclera. Push 
the tip about 1 mm into the sclera, keeping it parallel to the 
limbus.  
 

 
 

3) Redirect towards the centre of the eye into the vitreous cavity. 
This will create a shelved scleral path. 
Advance the needle until you enter the vitreous cavity. 
Do not advance the needle past the point where the sleeve of 
the applicator touches the conjunctiva. 
 
 
 
 
 

 

4) Depress the actuator button slowly until you hear a click.  
Before withdrawing the applicator from the eye, make sure 
that the actuator button is fully depressed and has locked flush 
with the applicator surface. 
 

 
 

5) Withdraw the applicator in the same direction that you used to 
enter the vitreous. 
 

 
 

6) Dispose of the applicator safely immediately after treatment.  
The OZURDEX applicator is for single use only. 
 

 

 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.  



16 

 
7. MARKETING AUTHORISATION HOLDER 
 
Allergan Pharmaceuticals Ireland 
Castlebar Road, 
Co. Mayo 
Westport 
Ireland 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/10/638/001 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 27/07/2010 
Date of latest renewal: 23/03/2015 
 
 
10. DATE OF REVISION OF THE TEXT 
 
MM/YYYY 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/. 

http://www.ema.europa.eu/


17 

 
ANNEX II 

 
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 
THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 



18 

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer responsible for batch release 
 
Allergan Pharmaceuticals Ireland 
Castlebar Road 
Westport, Co Mayo 
Ireland  
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic Safety Update Reports 

The marketing authorisation holder shall submit periodic safety update reports for this product in 
accordance with the requirements set out in the list of Union reference dates (EURD list) provided for 
under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal. 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT 

 
• Risk Management Plan (RMP) 

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the 
agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent 
updates of the RMP. 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency  

• Whenever the risk management system is modified, especially as the result of  new 
information being received that may lead to a significant change to the benefit:risk profile or 
as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached  

If the dates for submission of a PSUR and the update of the RMP coincide, they can be submitted at 
the same time.  

• Additional risk minimisation measures   
 

Prior to launch in each Member State the Marketing Authorisation Holder (MAH) shall agree the final 
educational material with the National Competent Authority. 

The MAH shall ensure that, following discussions and agreement with the National Competent 
Authorities in each Member State where OZURDEX is marketed, at launch and after launch all 
ophthalmological clinics where OZURDEX is expected to be used are provided with an up-to-date 
patient information pack. 

 



19 

The patient information pack should be provided in both the form of patient information booklet and 
an audio-CD that contain following key elements: 

• Patient information leaflet 

• How to prepare for OZURDEX treatment 

• What are the steps following treatment with OZURDEX 

• Key signs and symptoms of serious adverse events including: worsening of vision after the 
injection; pain or discomfort in or around the eye, redness of the eye which continues to get 
worse; increase in floaters or spots in the vision; discharge from the eye  

• When to seek urgent attention from their health care provider 



20 

  

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



21 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



22 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE 
PACKAGING 
 
CARTON AND POUCH EXTENDED LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
OZURDEX 700 micrograms intravitreal implant in applicator 
dexamethasone 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
One implant contains 700 micrograms of dexamethasone  
 
3. LIST OF EXCIPIENTS 
 
Contains  
Ester terminated 50:50 poly D,L-lactide-co-glycolide. 
Acid terminated 50:50 poly D,L-lactide-co-glycolide. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
One intravitreal implant in applicator. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Single use only. 
Read the package leaflet before use. 
Intravitreal use.  
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH AND OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Do not use if foil pouch seal is damaged. 
 
8. EXPIRY DATE 
 
EXP 
Once pouch opened, use applicator immediately. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
 
 



23 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Allergan Pharmaceuticals Ireland 
Castlebar Road 
Westport 
Co. Mayo 
Ireland 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/10/638/001 
 
13. BATCH NUMBER 
 
Lot  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 
 
17.   UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18.   UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 



24 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
APPLICATOR LABEL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
OZURDEX 700 micrograms intravitreal implant in applicator 
dexamethasone 
Intravitreal use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot  
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 implant 
 
6. OTHER 
 



25 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



26 

Package leaflet: information for the user 
 

OZURDEX 700 micrograms intravitreal implant in applicator 
dexamethasone 

 
Read all of this leaflet carefully before you are given this medicine because it contains important 

information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor. 
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, 

please tell your doctor.  See section 4. 
 
What is in this leaflet 
  
1. What OZURDEX is and what it is used for 
2. What you need to know before you are given OZURDEX 
3. How OZURDEX is used 
4. Possible side effects 
5. How to store OZURDEX 
6. Contents of the pack and other information 
 
1. What OZURDEX is and what it is used for 
 
The active substance in OZURDEX is dexamethasone. Dexamethasone belongs to a group of 
medicines called corticosteroids.  
 
OZURDEX is used to treat adult patients with: 
 

• Vision loss due to diabetic macular oedema (DME), if you have already had an operation for 
cataract, or if you have not previously responded to, or are not suitable for, other types of 
treatment.  Diabetic macular oedema is a swelling of the light-sensitive layer at the back of the 
eye called the macula.  DME is a condition that affects some people with diabetes.  

 
• Vision loss caused by a blockage of veins in the eye. This blockage leads to a build up of fluid 

causing swelling in the area of the retina (the light-sensitive layer at the back of the eye) called 
the macula.  
 
Swelling of the macula may lead to damage which affects your central vision which is used for 
tasks like reading.  OZURDEX works by reducing this swelling of the macular which helps to 
lessen or prevent more damage to the macula. 

 
• Inflammation of the back of the eye. This inflammation leads to a decrease of vision and/or 

the presence of floaters in the eye, (black dots or wispy lines that move across the field of 
vision). OZURDEX works by reducing this inflammation. 

 
2. What you need to know before you are given OZURDEX 
 
You must not be given OZURDEX 
 
- if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in 

section 6) 
- if you have an infection of any kind in or around your eye (bacterial, viral or fungal) 
- if you have glaucoma or high pressure inside your eye which is not controlled properly with the 

medicines you may be using 
-  if the eye to be treated does not have a lens and the back of the lens capsule (“the bag”) has been 

ruptured 



27 

-  if the eye to be treated has undergone cataract surgery and has a man-made lens, which was 
implanted in the front compartment of the eye (anterior chamber intraocular lens) or was fixed 
to the white portion of the eye (sclera) or to the coloured part of the eye (iris), and the back of 
the lens capsule (“the bag”) has been ruptured 

 
Warnings and precautions 
 
Before your OZURDEX injection tell your doctor if: 
- You have had cataract surgery, iris surgery (the coloured part of the eye that controls the 

amount of light that enters into the eye) or surgery to remove the gel (called the vitreous) from 
within the eye 

- You are taking any medicines to thin the blood 
- You are taking any steroid or non-steroidal anti-inflammatory medicines by mouth or applied to 

the eye 
- You have had a herpes simplex infection in your eye in the past (an ulcer on the eye that has 

been there a long time, or sores on the eye)  
 
Occasionally the injection of OZURDEX may cause an infection inside the eye, pain or redness in the 
eye, or a detachment or tear of the retina. It is important to identify and treat these as soon as possible. 
Please tell your doctor immediately if you develop increased eye pain or increased discomfort, 
worsening redness of your eye, flashing lights and sudden increase in floaters, partially blocked vision, 
decreased vision or increased sensitivity to light after your injection. 
 
In some patients the eye pressure may increase with the possible development of glaucoma. This is 
something you may not notice so your doctor will monitor you regularly and, if necessary provide 
treatment to lower the eye pressure. 
 
In the majority of patients who have not yet had an operation for cataract, a clouding of the eye's 
natural lens (a cataract) may occur after repeated treatment with OZURDEX. If this occurs your vision 
will decrease, and you are likely to need an operation to remove the cataract. Your doctor will help 
you to decide when is the most appropriate time to perform this operation, but you should be aware 
that until you are ready for your operation your vision may be as bad or worse than it was before you 
started receiving your OZURDEX injections. 
 
The implant can move from the back to the front of the eye in patients with a tear in the back of the 
lens capsule and/or those who have an opening in the iris. This can lead to swelling of the clear layer 
in the front of the eye and cause blurred vision.  If this continues for a long time and is left untreated,   
it may require tissue transplantation.  
 
The injection of OZURDEX into both eyes at the same time has not been studied and is not 
recommended. Your doctor should not inject OZURDEX into both eyes at the same time. 
 
Children and adolescent (below 18 years of age) 
The use of OZURDEX in children and adolescents has not been studied and is therefore not 
recommended. 
 
Other medicines and OZURDEX 
Tell your doctor if you are taking or have recently taken any other medicines, including medicines 
obtained without a prescription. 
 
Pregnancy and breast-feeding  
There is no experience of using OZURDEX in pregnant women or during breast-feeding.  OZURDEX 
should not be used during pregnancy or breast-feeding unless your doctor thinks it is clearly necessary. 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, 
discuss this with your doctor before OZURDEX treatment. Ask your doctor for advice before taking 
any medicine. 
 



28 

Driving and using machines 
 
After OZURDEX treatment you may experience some reduced vision for a short time.  If this happens, 
do not drive or use any tools or machines until your vision improves.  
 
3. How OZURDEX is used 
 
All OZURDEX injections will be given by an appropriately qualified eye doctor. 
 
The recommended dose is one implant to be given by injection into your eye. If the effect of this 
injection wears off and your doctor recommends it, another implant may then be injected into your 
eye. 
 
Your doctor will ask you to use antibiotic eye drops daily for 3 days before and after each injection to 
prevent any eye infection. Please follow these instructions carefully. 
 
On the day of the injection, your doctor may use antibiotic eye drops to prevent infection. Before the 
injection, your doctor will clean your eye and eyelid. Your doctor will also give you a local anaesthetic 
to reduce or prevent any pain you might have with the injection. You may hear a ‘click’ during the 
injection of OZURDEX; this is normal. 
 
Detailed instructions for your doctor on how to carry out the OZURDEX injection are provided 
in the medicine carton. 
 
If you have any further questions on the use of this medicine, ask your doctor. 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
 
The following side effects may be seen with OZURDEX:  
 
Very common (may affect more than 1 in 10 people):  
 
  Increased pressure in the eye, clouding of the lens (cataract), bleeding on the 

surface of the eye* 
 
Common (may affect up to 1 in 10 people):  
 
  High pressure in the eye, clouding at the back of the lens, bleeding into the inside of 

the eye*, worsening of vision*, difficulties in seeing clearly, detachment of the jelly 
inside the eye from the light-sensitive layer at the back of the eye (vitreous 
detachment)*, a feeling of spots in front of the eye (including ‘floaters’)*, a feeling 
of looking through mist or fog*, inflammation of the eyelid, eye pain*, seeing 
flashes of light*, swelling of the layer over the white part of the eye*, redness of the 
eye*,  headache 

 
Uncommon (may affect up to 1 in 100 people):  
  A severe inflammation at the back of the eye (usually due to viral infection), 

serious infection or inflammation inside the eye*, glaucoma (an eye disease in 
which increased pressure in the eye is associated with damage to the optic nerve), 
detachment of the light-sensitive layer from the back of the eye* (retinal 
detachment), tear of the light-sensitive layer at the back of the eye (retinal tear)*, a 
decrease in the eye pressure which is associated with leakage of the jelly (vitreous) 
from inside the eye*, inflammation inside the front part of the eye*, increased 
protein and cells in the front of the eye due to inflammation*, 



29 

abnormal feeling in the eye * itchiness of the eyelid, redness of the white of the 
eye*, migration of the OZURDEX implant from the back to the front of the eye 
causing blurred or decreased vision and which may or may not cause swelling of 
the clear part of the eye (cornea)*, accidental incorrect placement of the 
OZURDEX implant*, migraine 

 
*These side effects may be caused by the injection procedure and not the OZURDEX implant itself.  
The more injections you have the more these effects can occur. 
 
 
Reporting of side effects 
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this 
leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. 
By reporting side effects you can help provide more information on the safety of this medicine. 
 
5. How to store OZURDEX 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use OZURDEX after the expiry date which is stated on the carton and the pouch after EXP:. 
The expiry date refers to the last day of that month. 
 
This medicine does not require any special storage conditions. 
 
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 
dispose of medicines no longer required. These measures will help to protect the environment. 
 
6. Contents of the pack and other information 
 
What OZURDEX contains 
 
- The active substance is dexamethasone. 
- Each implant contains 700 micrograms of dexamethasone. 
-    The other ingredients are: Ester terminated 50:50 poly D,L-lactide-co-glycolide and 

Acid terminated 50:50 poly D,L-lactide-co-glycolide. 
 
What OZURDEX looks like and contents of the pack 
 
OZURDEX is a rod-shaped implant which is stored inside the needle of an applicator. The applicator 
and a packet of drying material are sealed in a foil pouch which is inside a carton. One carton contains 
one applicator with one implant which will be used once and thrown away. 
 
Marketing Authorisation Holder and Manufacturer 
 
Allergan Pharmaceuticals Ireland 
Castlebar Road 
Westport 
Co. Mayo 
Ireland 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien/ 
Luxembourg/Luxemburg/ Nederland 
Allergan n.v 
Tél/Tel: +32 (0)2 351 24 24 

Latvija 
Allergan Baltics UAB 
Tel: +371 676 60 831 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


30 

 
България 
Алерган България ЕООД 
Тел.: +359 (0) 800 20 280 
 

Lietuva 
Allergan Baltics UAB 
Tel: +37052 072 777 
 

Česká republika 
Allergan CZ s.r.o. 
Tel: +420 800 188 818 
 

Magyarország 
Allergan Hungary Kft. 
Tel.: +36 80 100 101 
 

Danmark 
Allergan Norden AB 
Tlf: + 4580884560 
 

Norge 
Allergan Norden AB 
Tlf: +47 80 01 04 97 
 

Deutschland 
Pharm-Allergan GmbH 
Tel: +49 69 92038 1050  
 

Österreich  
Pharm-Allergan GmbH 
Tel: +43 1 99460 6355 

Eesti 
Allergan Baltics UAB 
Tel: + 37 2634 6109 
 
Ελλάδα/Κύπρος 
Allergan Hellas Pharmaceuticals S.A. 
Τηλ: +30 210 74 73 300 
 

Polska 
Allergan Sp. z o.o. 
Tel.: +48 22 256 3700 
 
Portugal 
Profarin Lda.  
Tel: + 351 21 425 3242 
 

España 
Allergan S.A. 
Tel: + 34 91 807 6130 
 

România 
Allergan S.R.L. 
Tel: +40 21 301 53 02 
 

France 
Allergan France SAS 
Tél: +33 (0)1 49 07 83 00 
 

Slovenija 
Ewopharma d.o.o. 
Tel: + 386 (0) 590 848 40  
 

Hrvatska 
Ewopharma d.o.o. 
Tel: +385 1 6646 563 
 

Slovenská republika 
Allergan SK s.r.o. 
Tel: +421 800 221 223 
 

Ireland/Malta 
Allergan Pharmaceuticals Ireland 
Tel: 1800 931 787 (IE) 
       +356 27780331 (MT) 
 
Ísland 
Actavis Pharmaceuticals Iceland ehf. 
Sími: +354 550 3300 
 

Suomi/Finland 
Allergan Norden AB 
Puh/Tel: + 358 800 115 003 
 
 
Sverige 
Allergan Norden AB 
Tel: + 46859410000 
 

Italia 
Allergan S.p.A 
Tel: + 39 06 509 562 90 
 
 
 

United Kingdom 
Allergan Ltd 
Tel: +44 (0) 1628 494026 
 
 
 



31 

 
This leaflet was last revised in MM/YYY 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/.  



32 

--------------------------------------------------------------------------------------------------------------------------- 
 
[To be provided in the carton] 
 
The following information is intended for medical or healthcare professionals only, and includes the 
numbered sections of the SmPC which provide practical information for use of the medicinal product. 
Please refer to the SmPC for full product information. 
 
INFORMATION FOR THE HEALTHCARE PROFESSIONAL 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
OZURDEX 700 micrograms intravitreal implant in applicator 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
OZURDEX is indicated for the treatment of adult patients with: 

• visual impairment due to diabetic macular oedema (DME) who are pseudophakic or who are 
considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy 

• macular oedema following either Branch Retinal Vein Occlusion (BRVO) or Central Retinal 
Vein Occlusion (CRVO) (see SmPC section 5.1) 

• inflammation of the posterior segment of the eye presenting as non-infectious uveitis  
  
4.2 Posology and method of administration 
 
OZURDEX must be administered by a qualified ophthalmologist experienced in intravitreal injections. 
 
Posology 
The recommended dose is one OZURDEX implant to be administered intra-vitreally to the affected 
eye. Administration to both eyes concurrently is not recommended (see SmPC section 4.4). 
 
Patients should be monitored following the injection to permit early treatment if an infection or 
increased intraocular pressure occurs (see SmPC section 4.4). 
 
Special populations 
Elderly (≥65 years old) 
No dose adjustment is required for elderly patients. 
 
Method of administration 
OZURDEX is a single-use intravitreal implant in applicator for intravitreal use only. 
 
Each applicator can only be used for the treatment of a single eye. 
 
The intravitreal injection procedure should be carried out under controlled aseptic conditions which 
include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent).    
 
The patient should be instructed to self-administer broad spectrum antimicrobial drops daily for 3 days 
before and after each injection. Before the injection, the periocular skin, eyelid and ocular surface 
should be disinfected (using for example drops of povidone iodine 5% solution on the conjunctiva as it 
was done in the clinical trials for the approval of OZURDEX) and adequate local anaesthesia should 
be administered.  Remove the foil pouch from the carton and examine for damage (see SmPC 
section 6.6). Then, in a sterile field, open the foil pouch and gently place the applicator on a sterile 
tray. Carefully remove the cap from the applicator. Once the foil pouch is opened the applicator should 
be used immediately. Hold the applicator in one hand and pull the safety tab straight off the applicator. 
Do not twist or flex the tab. With the bevel of the needle up away from the sclera, advance the needle 



33 

about 1 mm into the sclera then redirect toward the centre of the eye into the vitreous cavity until the 
silicone sleeve is against the conjunctiva. Slowly press the actuator button until an audible click is 
noted. Before withdrawing the applicator from the eye, make sure that the actuator button is fully 
pressed and has locked flush with the applicator surface. Remove the needle in the same direction as 
used to enter the vitreous. 
 
For instructions on the administration of the intravitreal implant, see section 6.6 
 
Immediately after injecting OZURDEX, use indirect ophthalmoscopy in the quadrant of injection to 
confirm successful implantation. Visualisation is possible in the large majority of cases.  In cases in 
which the implant cannot be visualised, take a sterile cotton bud and lightly depress over the injection 
site to bring the implant into view.  
 
Following the intravitreal injection patients should continue to be treated with a broad spectrum 
antimicrobial.  
 
4.3 Contraindications 
 
• Hypersensitivity to the active substance or to any of the excipients as listed in SmPC 

section 6.1.  
• Active or suspected ocular or periocular infection including most viral diseases of the cornea 

and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), 
vaccinia, varicella, mycobacterial infections, and fungal diseases. 

• Advanced glaucoma which cannot be adequately controlled by medicinal products alone. 
• Aphakic eyes with ruptured posterior lens capsule. 
• Eyes with Anterior Chamber Intraocular Lens (ACIOL), iris or transscleral fixated intraocular 

lens and ruptured posterior lens capsule. 
 
 
4.4 Special warnings and precautions for use 
 
Intravitreous injections, including those with OZURDEX, can be associated with endophthalmitis, 
intraocular inflammation, increased intraocular pressure and retinal detachment. Proper aseptic 
injection techniques must always be used. In addition, patients should be monitored following the 
injection to permit early treatment if an infection or increased intraocular pressure occurs. Monitoring 
may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry 
within 30 minutes following the injection, and biomicroscopy between two and seven days following 
the injection.  
 
Patients must be instructed to report any symptoms suggestive of endophthalmitis or any of the above 
mentioned events without delay, e.g. eye pain, blurred vision etc. (see SmPC section 4.8). 
 
All patients with posterior capsule tear, such as those with a posterior lens (e.g. due to cataract 
surgery), and/or those who have an iris opening to the vitreous cavity (e.g. due to iridectomy) with or 
without a history of vitrectomy, are at risk of implant migration into the anterior chamber. Implant 
migration to the anterior chamber may lead to corneal oedema.  Persistent severe corneal oedema 
could progress to the need for corneal transplantation.  Other than those patients contraindicated (see 
SmPC section 4.3) where OZURDEX should not be used, OZURDEX should be used with caution 
and only following a careful risk benefit assessment. These patients should be closely monitored to 
allow for early diagnosis and management of device migration.  
 
Use of corticosteroids, including OZURDEX, may induce cataracts (including posterior subcapsular 
cataracts), increased IOP, steroid induced glaucoma and may result in secondary ocular infections.  
 
In the 3 year DME clinical studies, 59% of patients with a phakic study eye treated with OZURDEX 
underwent cataract surgery in the study eye (see SmPC section 4.8).   
 



34 

After the first injection the incidence of cataract appears higher in patients with non-infectious uveitis 
of the posterior segment compared with BRVO/CRVO patients.  In BRVO/CRVO clinical studies, 
cataract was reported more frequently in patients with phakic lens receiving a second injection (see 
SmPC section 4.8).  Only 1 patient out of 368 required cataract surgery during the first treatment and 
3 patients out of 302 during the second treatment. In the non-infectious uveitis study, 1 patient out of 
the 62 phakic patients underwent cataract surgery after a single injection. 
 
The prevalence of conjunctival haemorrhage in patients with non-infectious uveitis of the posterior 
segment appears to be higher compared with BRVO/CRVO and DME.   This could be attributable to 
the intravitreous injection procedure or to concomitant use of topical and/or systemic corticosteroid or 
Non-steroidal anti-inflammatory medications.  No treatment is required since spontaneous resolution 
occurs. 
 
As expected with ocular steroid treatment and intravitreal injections, increases in intraocular pressure 
(IOP) may be seen.  The rise in IOP is normally manageable with IOP lowering medication (see 
section 4.8).  Of the patients experiencing an increase of IOP of ≥10 mmHg from baseline, the greatest 
proportion showed this IOP increase between 45 and 60 days following an injection.  Therefore, 
regular monitoring of IOP, irrespective of baseline IOP, is required and any elevation should be 
managed appropriately post-injection as needed.   Patients of less than 45 years of age with macular 
oedema following Retinal Vein Occlusion or inflammation of the posterior segment of the eye 
presenting as non-infectious uveitis are more likely to experience increases in IOP.   
 
Corticosteroids should be used cautiously in patients with a history of ocular herpes simplex and not 
be used in active ocular herpes simplex. 
 
The safety and efficacy of  OZURDEX administered to both eyes concurrently have not been studied.  
Therefore administration to both eyes concurrently is not recommended.   
 
OZURDEX has not been studied in patients with macular oedema secondary to RVO with significant 
retinal ischemia. Therefore OZURDEX is not recommended. 
 
A limited number of subjects with Type 1 diabetes were investigated in the Phase 3 studies, and the 
response to OZURDEX in these subjects was not significantly different to those subjects with Type 2 
diabetes.   
 
In RVO, anti-coagulant therapy was used in 2% of patients receiving OZURDEX; there were no 
reports of haemorrhagic adverse events in these patients.  In DME, anti-coagulant therapy was used in 
8% of patients.  Among patients who used anti-coagulant therapy, the frequency of haemorrhagic 
adverse events was similar in the OZURDEX and sham groups (29% vs 32%).  Among patients who 
did not use anti-coagulant therapy, 27% of OZURDEX treated patients reported haemorrhagic adverse 
events compared to 20% in the sham group.  Vitreous haemorrhage was reported in a higher 
proportion of patients treated with OZURDEX who received anti-coagulant therapy (11%) compared 
with those not receiving anticoagulant therapy  (6%).  
 
Anti-platelet medicinal products, such as clopidogrel, were used at some stage during the clinical 
studies in up to 56% of patients.  For patients using concomitant and anti-platelet medication, 
haemorrhagic adverse events were reported in a slightly higher proportion of patients injected with 
OZURDEX (up to 29%) compared with the sham group (up to 23%), irrespective of indication or 
number of treatments.  The most common haemorrhagic adverse event reported was conjunctival 
haemorrhage (up to 24%).    
 
OZURDEX should be used with caution in patients taking anti-coagulant or anti-platelet medicinal 
products. 
 
Visual disturbance 



35 

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents 
with symptoms such as blurred vision or other visual disturbances, consider evaluating for possible 
causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy 
(CSCR) which have been reported after use of systemic and topical corticosteroids. 
 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No interaction studies have been performed.  
Systemic absorption is minimal and no interactions are anticipated. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
Studies in animals have shown teratogenic effects following topical ophthalmic administration (see 
SmPC section 5.3). There are no adequate data from the use of intravitreally administered 
dexamethasone in pregnant women. Long-term systemic treatment with glucocorticoids during 
pregnancy increases the risk for intra-uterine growth retardation and adrenal insufficiency of the 
newborn child. Therefore, although the systemic exposure of dexamethasone would be expected to be 
very low after local, intraocular treatment. OZURDEX is not recommended during pregnancy unless 
the potential benefit justifies the potential risk to the foetus. 
 
Breast-feeding 
Dexamethasone is excreted in breast milk  No effects on the child are anticipated due to the route of 
administration and the resulting systemic levels. However OZURDEX is not recommended during 
breast feeding unless clearly necessary.  
 
Fertility 
There are no fertility data available. 
 
4.7 Effects on ability to drive and use machines 
 
OZURDEX may have a moderate influence on the ability to drive and use machines.  Patients may 
experience temporarily reduced vision after receiving OZURDEX by intravitreal injection (see SmPC 
section 4.8). They should not drive or use machines until this has resolved. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The most commonly-reported adverse events reported following treatment with OZURDEX are those 
frequently observed with ophthalmic steroid treatment or intravitreal injections (elevated IOP, cataract 
formation and conjunctival or vitreal haemorrhage respectively). 
 
Less frequently reported, but more serious, adverse reactions include endophthalmitis, necrotizing 
retinitis, retinal detachment and retinal tear. 
 
With the exception of headache and migraine, no systemic adverse drug reactions were identified with 
the use of OZURDEX. 
 
Tabulated list of adverse reactions  
The adverse reactions considered related to OZURDEX treatment from the Phase III clinical trials 
(DME, BRVO/CRVO and uveitis) and spontaneous reporting are listed by MedDRA System organ 
class in the table below using the following convention:  
 
Very common (≥ 1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 
to <1/1,000); very rare (<1/10,000).  Within each frequency grouping, adverse reactions are presented 
in order of decreasing seriousness. 



36 

 
Table 1     Adverse reactions 
 

System organ class Frequency Adverse reaction 
Nervous system disorders Common Headache 
 Uncommon Migraine 
Eye disorders Very common Intraocular pressure increased**, cataract**, 

conjunctival haemorrhage*  
 Common Ocular hypertension, cataract subcapsular, vitreous 

haemorrhage**, visual acuity reduced*, visual 
impairment/ disturbance, vitreous detachment*, 
vitreous floaters*, vitreous opacities*, blepharitis,  
eye pain*, photopsia*, conjunctival oedema* 
conjunctival hyperaemia* 

 Uncommon Necrotizing retinitis, endophthalmitis*, glaucoma, 
retinal detachment*, retinal tear*, hypotony of the 
eye*, anterior chamber inflammation*, anterior 
chamber cells/ flares*, abnormal sensation in eye*, 
eyelids pruritus,  scleral hyperaemia* 

General disorders and 
administration site 
conditions 

Uncommon Device dislocation* (migration of implant) with or 
without corneal oedema (see also section 4.4), 
complication of device insertion resulting in ocular 
tissue injury* (implant misplacement) 

 
* indicates adverse reactions considered to be related to the intravitreal injection procedure (the frequency of 
these adverse reactions is proportional to the number of treatments given). 
** in a 24-month real world observational study in the treatment of macular oedema following RVO and non-
infectious uveitis affecting the posterior segment of the eye these adverse events were reported more frequently 
among patients who received >2 injections vs patients who received ≤2 injections; cataract formation (24.7% vs 
17.7%), cataract progression (32.0% vs 13.1%), vitreous haemorrhage (6.0% vs 2.0%), and increased IOP 
(24.0% vs 16.6%). 
 
 
Description of selected adverse reactions 
Diabetic Macular Oedema 
 
The clinical safety of OZURDEX in patients with diabetic macular oedema was assessed in two phase 
3 randomized, double-masked, sham-controlled studies. In both studies, a total of 347 patients were 
randomized and received OZURDEX and 350 patients received sham. 
 
The most frequently reported adverse reactions across the entire study period in the study eye of 
patients who received OZURDEX were cataract and elevated IOP (see below). 
  
In the 3 year DME clinical studies, at baseline, 87% of patients with a phakic study eye treated with 
OZURDEX had some degree of lens opacification/ early cataract.  The incidence of all observed 
cataract types (i.e. cataract cortical, cataract diabetic, cataract nuclear, cataract subcapsular, cataract 
lenticular, cataract) was 68% in OZURDEX treated patients with a phakic study eye across the 3 year 
studies.  59% of patients with a phakic study eye required cataract surgery by the 3 year final visit, 
with the majority performed in the 2nd and 3rd years. 
 
Mean IOP in the study eye at baseline was the same in both treatment groups (15.3 mmHg).  The 
mean increase from baseline IOP did not exceed 3.2  mmHg across all visits in the OZURDEX group 
with the mean IOP peaking at the 1.5  month visit post injection, and returning to approximately 
baseline levels by month 6 following each injection.  The rate and magnitude of IOP elevation 
following OZURDEX treatment did not increase upon repeated injection of OZURDEX.  
 



37 

28% of patients treated with OZURDEX had a ≥ 10 mm Hg IOP increase from baseline at one or more 
visits during the study.  At baseline 3% of patients required IOP-lowering medication(s).  Overall, 
42% of patients required IOP-lowering medications in the study eye at some stage during the 3 year 
studies, with the majority of these patients requiring more than one medication.  Peak usage (33%) 
occurred during the first 12  months and remained similar from year to year.   
 
A total of 4 patients  (1%) treated with OZURDEX had procedures in the study eye for the treatment 
of IOP elevation.  One patient treated with OZURDEX required incisional surgery (trabeculectomy) to 
manage the steroid-induced IOP elevation, 1 patient had a trabeculectomy owing to anterior chamber 
fibrin blocking the aqueous outflow leading to increased IOP, 1 patient had an iridotomy for narrow 
angle glaucoma and 1  patient had iridectomy due to cataract surgery.  No patient required removal of 
the implant by vitrectomy to control IOP. 
 
BRVO/CRVO 
The clinical safety of OZURDEX in patients with macular oedema following central or branch retinal 
vein occlusion has been assessed in two Phase III randomised, double-masked, sham-controlled 
studies. A total of 427 patients were randomised to receive OZURDEX and 426 to receive sham in the 
two Phase III studies. A total of 401 patients (94 %) randomised and treated with OZURDEX 
completed the initial treatment period (up to day 180).  
 
A total of 47.3 % of patients experienced at least one adverse reaction. The most frequently reported 
adverse reactions in patients who received OZURDEX were increased intraocular pressure (24.0 %) 
and conjunctival haemorrhage  (14.7 %). 
 
The adverse reaction profile for BRVO patients was similar to that observed for CRVO patients 
although the overall incidence of adverse reactions was higher for the subgroup of patients with 
CRVO. 
 
Increased intraocular pressure (IOP) with OZURDEX peaked at day 60 and returned to baseline levels 
by day 180.  Elevations of IOP either did not require treatment or were managed with the temporary 
use of topical IOP-lowering medicinal products. During the initial treatment period, 0.7 % (3/421) of 
the patients who received OZURDEX required laser or surgical procedures for management of 
elevated IOP in the study eye compared with 0.2 % (1/423) with sham.   
 
The adverse reaction profile of 341 patients analysed following a second injection of OZURDEX, was 
similar to that following the first injection. A total of 54 % of patients experienced at least one adverse 
reaction.  The incidence of increased IOP (24.9 %) was similar to that seen following the first injection 
and likewise returned to baseline by open-label day 180. The overall incidence of cataracts was higher 
after 1 year compared to the initial 6 months. 
 
Uveitis 
The clinical safety of OZURDEX in patients with inflammation of the posterior segment of the eye 
presenting as non-infectious uveitis, has been assessed in a single, multicentre, masked, randomised 
study. 
 
A total of 77 patients were randomised to receive OZURDEX and 76 to receive Sham. A total of 
73 patients (95%) randomised and treated with OZURDEX completed the 26-week study. 
 
The most frequently reported adverse reactions in the study eye of patients who received OZURDEX 
were conjunctival haemorrhage (30.3%), increased intraocular pressure (25.0%) and cataract (11.8%). 
 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


38 

 
4.9 Overdose 
 
If an overdose occurs, intraocular pressure should be monitored and treated, if deemed necessary by 
the attending physician. 
 
5.3 Preclinical safety data  
 
Effects in non-clinical studies were observed only at doses considered sufficiently in excess of the 
maximum dose for human indicating little relevance to clinical use. 
 
No mutagenicity, carcinogenicity, reproductive or developmental toxicity data are available for 
OZURDEX. Dexamethasone has been shown to be teratogenic in mice and rabbits following topical 
ophthalmic application. 
 
Dexamethasone exposure to the healthy/untreated eye via contralateral diffusion has been observed in 
rabbits following delivery of the implant to the posterior segment of the eye. 
 
6. PHARMACEUTICAL PARTICULARS 
 
 
6.6 Special precautions for disposal  and other handling 
 
OZURDEX is for single use only. 
Each applicator can only be used for the treatment of a single eye.  
 
If the seal of the foil pouch containing the applicator is damaged, the applicator must not be used. 
Once the foil pouch is opened the applicator should be used immediately. 
 
Administering OZURDEX  
 
1) Hold the long axis of the applicator parallel to the limbus.  

 

 
 

2) Allow the applicator to meet the sclera at an oblique angle with 
the bevel of the needle facing up, away from the sclera. Push 
the tip about 1 mm into the sclera, keeping it parallel to the 
limbus.  
 

 
 



39 

3) Redirect towards the centre of the eye into the vitreous cavity. 
This will create a shelved scleral path. 
Advance the needle until you enter the vitreous cavity. 
Do not advance the needle past the point where the sleeve of 
the applicator touches the conjunctiva. 
 
 
 
 
 

 

4) Depress the actuator button slowly until you hear a click.  
Before withdrawing the applicator from the eye, make sure 
that the actuator button is fully depressed and has locked flush 
with the applicator surface. 
 
 
 
 
 
 

 

5) Withdraw the applicator in the same direction that you used to 
enter the vitreous. 
 

 
 

6) Dispose of the applicator safely immediately after treatment.  
The OZURDEX applicator is for single use only. 
 

 

 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
{'Title': '1. what ozurdex is and what it is used for', 'Section_Content': 'the active substance in ozurdex is dexamethasone. dexamethasone belongs to a group of medicines called corticosteroids. ozurdex is used to treat adult patients with: vision loss due to diabetic macular oedema (dme), if you have already had an operation for cataract, or if you have not previously responded to, or are not suitable for, other types of treatment. diabetic macular oedema is a swelling of the light-sensitive layer at the back of the eye called the macula. dme is a condition that affects some people with diabetes. vision loss caused by a blockage of veins in the eye. this blockage leads to a build up of fluid causing swelling in the area of the retina (the light-sensitive layer at the back of the eye) called the macula. swelling of the macula may lead to damage which affects your central vision which is used for tasks like reading. ozurdex works by reducing this swelling of the macular which helps to lessen or prevent more damage to the macula. inflammation of the back of the eye. this inflammation leads to a decrease of vision and/or the presence of floaters in the eye, (black dots or wispy lines that move across the field of vision). ozurdex works by reducing this inflammation.', 'Entity_Recognition': [{'Text': 'ozurdex', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 17, 'BeginOffset': 24, 'EndOffset': 31, 'Score': 0.9924108982086182, 'Text': 'ozurdex', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.5190262198448181}]}, {'Id': 18, 'BeginOffset': 35, 'EndOffset': 48, 'Score': 0.9996373653411865, 'Text': 'dexamethasone', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 19, 'BeginOffset': 50, 'EndOffset': 63, 'Score': 0.992717981338501, 'Text': 'dexamethasone', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'a group of medicines', 'Type': 'TREATMENT', 'BeginOffset': 75, 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{'Title': '2. what you need to know before you are given ozurdex', 'Section_Content': 'you must not be given ozurdex - if you are allergic to dexamethasone or any of the other ingredients of this medicine (listed in section 6) - if you have an infection of any kind in or around your eye (bacterial, viral or fungal) - if you have glaucoma or high pressure inside your eye which is not controlled properly with the medicines you may be using - if the eye to be treated does not have a lens and the back of the lens capsule ("the bag") has been ruptured 27 - if the eye to be treated has undergone cataract surgery and has a man-made lens, which was implanted in the front compartment of the eye (anterior chamber intraocular lens) or was fixed to the white portion of the eye (sclera) or to the coloured part of the eye (iris), and the back of the lens capsule ("the bag") has been ruptured warnings and precautions before your ozurdex injection tell your doctor if: - you have had cataract surgery, iris surgery (the coloured part of the eye that controls the amount of light that enters into the eye) or surgery to remove the gel (called the vitreous) from within the eye - you are taking any medicines to thin the blood - you are taking any steroid or non-steroidal anti-inflammatory medicines by mouth or applied to the eye - you have had a herpes simplex infection in your eye in the past (an ulcer on the eye that has been there a long time, or sores on the eye) occasionally the injection of ozurdex may cause an infection inside the eye, pain or redness in the eye, or a detachment or tear of the retina. it is important to identify and treat these as soon as possible. please tell your doctor immediately if you develop increased eye pain or increased discomfort, worsening redness of your eye, flashing lights and sudden increase in floaters, partially blocked vision, decreased vision or increased sensitivity to light after your injection. in some patients the eye pressure may increase with the possible development of glaucoma. this is something you may not notice so your doctor will monitor you regularly and, if necessary provide treatment to lower the eye pressure. in the majority of patients who have not yet had an operation for cataract, a clouding of the eye\'s natural lens (a cataract) may occur after repeated treatment with ozurdex. if this occurs your vision will decrease, and you are likely to need an operation to remove the cataract. your doctor will help you to decide when is the most appropriate time to perform this operation, but you should be aware that until you are ready for your operation your vision may be as bad or worse than it was before you started receiving your ozurdex injections. the implant can move from the back to the front of the eye in patients with a tear in the back of the lens capsule and/or those who have an opening in the iris. this can lead to swelling of the clear layer in the front of the eye and cause blurred vision. if this continues for a long time and is left untreated, it may require tissue transplantation. the injection of ozurdex into both eyes at the same time has not been studied and is not recommended. your doctor should not inject ozurdex into both eyes at the same time. children and adolescent (below 18 years of age) the use of ozurdex in children and adolescents has not been studied and is therefore not recommended. other medicines and ozurdex tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. pregnancy and breast-feeding there is no experience of using ozurdex in pregnant women or during breast-feeding. ozurdex should not be used during pregnancy or breast-feeding unless your doctor thinks it is clearly necessary. if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, discuss this with your doctor before ozurdex treatment. ask your doctor for advice before taking any 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{'Title': '3. how ozurdex is used', 'Section_Content': "all ozurdex injections will be given by an appropriately qualified eye doctor. the recommended dose is one implant to be given by injection into your eye. if the effect of this injection wears off and your doctor recommends it, another implant may then be injected into your eye. your doctor will ask you to use antibiotic eye drops daily for 3 days before and after each injection to prevent any eye infection. please follow these instructions carefully. on the day of the injection, your doctor may use antibiotic eye drops to prevent infection. before the injection, your doctor will clean your eye and eyelid. your doctor will also give you a local anaesthetic to reduce or prevent any pain you might have with the injection. you may hear a 'click' during the injection of ozurdex; this is normal. detailed instructions for your doctor on how to carry out the ozurdex injection are provided in the medicine carton. if you have any further questions on the use of this medicine, ask your doctor.", 'Entity_Recognition': [{'Text': 'ozurdex', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all ozurdex injections', 'Type': 'TREATMENT', 'BeginOffset': 0, 'EndOffset': 22}, {'Id': 0, 'BeginOffset': 67, 'EndOffset': 70, 'Score': 0.6884866952896118, 'Text': 'eye', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Text': 'one implant', 'Type': 'TREATMENT', 'BeginOffset': 103, 'EndOffset': 114}, {'Id': 24, 'BeginOffset': 130, 'EndOffset': 139, 'Score': 0.3460477292537689, 'Text': 'injection', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'PROCEDURE_NAME', 'Traits': []}, {'Id': 1, 'BeginOffset': 150, 'EndOffset': 153, 'Score': 0.9707439541816711, 'Text': 'eye', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Text': 'this injection', 'Type': 'TREATMENT', 'BeginOffset': 172, 'EndOffset': 186}, {'Text': 'another implant', 'Type': 'TREATMENT', 'BeginOffset': 228, 'EndOffset': 243}, {'Id': 2, 'BeginOffset': 275, 'EndOffset': 278, 'Score': 0.9652840495109558, 'Text': 'eye', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 26, 'BeginOffset': 312, 'EndOffset': 332, 'Score': 0.6753686666488647, 'Text': 'antibiotic eye drops', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'TREATMENT_NAME', 'Traits': []}, {'Id': 3, 'BeginOffset': 323, 'EndOffset': 326, 'Score': 0.5616610050201416, 'Text': 'eye', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Text': '3', 'Type': 'NUMBER', 'BeginOffset': 343, 'EndOffset': 344}, {'Id': 27, 'BeginOffset': 372, 'EndOffset': 381, 'Score': 0.31980621814727783, 'Text': 'injection', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'PROCEDURE_NAME', 'Traits': []}, {'Text': 'any eye infection', 'Type': 'PROBLEM', 'BeginOffset': 393, 'EndOffset': 410}, {'Text': 'the injection', 'Type': 'TREATMENT', 'BeginOffset': 470, 'EndOffset': 483}, {'Id': 29, 'BeginOffset': 505, 'EndOffset': 525, 'Score': 0.6868510246276855, 'Text': 'antibiotic eye drops', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'TREATMENT_NAME', 'Traits': []}, {'Id': 5, 'BeginOffset': 516, 'EndOffset': 519, 'Score': 0.7191944718360901, 'Text': 'eye', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 21, 'BeginOffset': 537, 'EndOffset': 546, 'Score': 0.9914325475692749, 'Text': 'infection', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.9437822103500366}]}, {'Text': 'the injection', 'Type': 'TREATMENT', 'BeginOffset': 555, 'EndOffset': 568}, {'Id': 6, 'BeginOffset': 598, 'EndOffset': 601, 'Score': 0.9732508659362793, 'Text': 'eye', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 7, 'BeginOffset': 606, 'EndOffset': 612, 'Score': 0.9793373346328735, 'Text': 'eyelid', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Text': 'a local anaesthetic', 'Type': 'TREATMENT', 'BeginOffset': 645, 'EndOffset': 664}, {'Text': 'any pain', 'Type': 'PROBLEM', 'BeginOffset': 686, 'EndOffset': 694}, {'Text': 'the injection', 'Type': 'TREATMENT', 'BeginOffset': 715, 'EndOffset': 728}, {'Text': 'the injection of ozurdex', 'Type': 'TREATMENT', 'BeginOffset': 760, 'EndOffset': 784}, {'Text': 'the ozurdex injection', 'Type': 'TREATMENT', 'BeginOffset': 860, 'EndOffset': 881}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 967, 'EndOffset': 980}]}
{'Title': '4. possible side effects', 'Section_Content': "like all medicines, this medicine can cause side effects, although not everybody gets them. the following side effects may be seen with ozurdex: very common (may affect more than 1 in 10 people): increased pressure in the eye, clouding of the lens (cataract), bleeding on the surface of the eye* common (may affect up to 1 in 10 people): high pressure in the eye, clouding at the back of the lens, bleeding into the inside of the eye*, worsening of vision*, difficulties in seeing clearly, detachment of the jelly inside the eye from the light-sensitive layer at the back of the eye (vitreous detachment)*, a feeling of spots in front of the eye (including 'floaters')*, a feeling of looking through mist or fog*, inflammation of the eyelid, eye pain*, seeing flashes of light*, swelling of the layer over the white part of the eye*, redness of the eye*, headache uncommon (may affect up to 1 in 100 people): a severe inflammation at the back of the eye (usually due to viral infection), serious infection or inflammation inside the eye*, glaucoma (an eye disease in which increased pressure in the eye is associated with damage to the optic nerve), detachment of the light-sensitive layer from the back of the eye* (retinal detachment), tear of the light-sensitive layer at the back of the eye (retinal tear)*, a decrease in the eye pressure which is associated with leakage of the jelly (vitreous) from inside the eye*, inflammation inside the front part of the eye*, increased protein and cells in the front of the eye due to inflammation*, 29 abnormal feeling in the eye * itchiness of the eyelid, redness of the white of the eye*, migration of the ozurdex implant from the back to the front of the eye causing blurred or decreased vision and which may or may not cause swelling of the clear part of the eye (cornea)*, accidental incorrect placement of the ozurdex implant*, migraine *these side effects may be caused by the injection procedure and not the ozurdex implant itself. the more injections you have the more these effects can occur. reporting of side effects if you get any side effects, talk to your doctor. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system listed in appendix v. by reporting side effects you can help provide more information on the safety of this medicine.", 'Entity_Recognition': [{'Text': 'ozurdex', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 20, 'EndOffset': 33}, {'Id': 45, 'BeginOffset': 44, 'EndOffset': 56, 'Score': 0.9668263792991638, 'Text': 'side effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7248334288597107}]}, {'Id': 46, 'BeginOffset': 106, 'EndOffset': 118, 'Score': 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{'Title': '5. how to store ozurdex', 'Section_Content': 'keep this medicine out of the sight and reach of children. do not use ozurdex after the expiry date which is stated on the carton and the pouch after exp:. the expiry date refers to the last day of that month. this medicine does not require any special storage conditions. medicines should not be disposed of via wastewater or household waste. ask your pharmacist how to dispose of medicines no longer required. these measures will help to protect the environment.', 'Entity_Recognition': [{'Text': 'ozurdex', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 70, 'EndOffset': 77, 'Score': 0.9886970520019531, 'Text': 'ozurdex', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': 'medicines', 'Type': 'TREATMENT', 'BeginOffset': 273, 'EndOffset': 282}, {'Text': 'medicines', 'Type': 'TREATMENT', 'BeginOffset': 382, 'EndOffset': 391}, {'Text': 'these measures', 'Type': 'TREATMENT', 'BeginOffset': 412, 'EndOffset': 426}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what ozurdex contains - the active substance is dexamethasone. - each implant contains 700 micrograms of dexamethasone. - the other ingredients are: ester terminated 50:50 poly d,l-lactide-co-glycolide and acid terminated 50:50 poly d,l-lactide-co-glycolide. what ozurdex looks like and contents of the pack ozurdex is a rod-shaped implant which is stored inside the needle of an applicator. the applicator and a packet of drying material are sealed in a foil pouch which is inside a carton. one carton contains one applicator with one implant which will be used once and thrown away.', 'Entity_Recognition': [{'Text': 'ozurdex', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'what ozurdex', 'Type': 'PROBLEM', 'BeginOffset': 0, 'EndOffset': 12}, {'Id': 1, 'BeginOffset': 48, 'EndOffset': 61, 'Score': 0.9994874000549316, 'Text': 'dexamethasone', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'each implant', 'Type': 'TREATMENT', 'BeginOffset': 65, 'EndOffset': 77}, {'Text': '700', 'Type': 'NUMBER', 'BeginOffset': 87, 'EndOffset': 90}, {'Id': 3, 'BeginOffset': 105, 'EndOffset': 118, 'Score': 0.9995943903923035, 'Text': 'dexamethasone', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.9878454804420471, 'RelationshipScore': 0.9998610019683838, 'RelationshipType': 'DOSAGE', 'Id': 2, 'BeginOffset': 87, 'EndOffset': 101, 'Text': '700 micrograms', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 4, 'BeginOffset': 179, 'EndOffset': 201, 'Score': 0.9467318058013916, 'Text': 'l-lactide-co-glycolide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 5, 'BeginOffset': 206, 'EndOffset': 210, 'Score': 0.3800240159034729, 'Text': 'acid', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 6, 'BeginOffset': 228, 'EndOffset': 234, 'Score': 0.4873470366001129, 'Text': 'poly d', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 7, 'BeginOffset': 235, 'EndOffset': 257, 'Score': 0.9964356422424316, 'Text': 'l-lactide-co-glycolide', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'what ozurdex', 'Type': 'PROBLEM', 'BeginOffset': 259, 'EndOffset': 271}, {'Text': 'the pack ozurdex', 'Type': 'TREATMENT', 'BeginOffset': 299, 'EndOffset': 315}, {'Text': 'a rod-shaped implant', 'Type': 'TREATMENT', 'BeginOffset': 319, 'EndOffset': 339}, {'Text': 'an applicator', 'Type': 'TREATMENT', 'BeginOffset': 377, 'EndOffset': 390}, {'Text': 'the applicator', 'Type': 'TREATMENT', 'BeginOffset': 392, 'EndOffset': 406}, {'Text': 'a packet of drying material', 'Type': 'TREATMENT', 'BeginOffset': 411, 'EndOffset': 438}, {'Text': 'a foil pouch', 'Type': 'TREATMENT', 'BeginOffset': 453, 'EndOffset': 465}, {'Text': 'one implant', 'Type': 'TREATMENT', 'BeginOffset': 532, 'EndOffset': 543}]}