Background:
Iluvien(®) is a novel, nonbiodegradable, sustained-release drug delivery system (0.2 μg/d fluocinolone acetonide [FAc]) indicated in Europe for the treatment of vision impairment associated with chronic diabetic macular edema (DME), considered insufficiently responsive to available therapies.
Objective:
To evaluate the safety and efficacy of 190-μg FAc implant in patients with chronic DME refractory to other medical treatment options in a clinical setting.
Methods:
Retrospective registry data were collected by using standard case report forms (CRFs). Prior to intravitreal injection of the FAc implant, all patients were treated either with a vascular endothelial growth factor (VEGF) antagonist and/or a steroid (triamcinolone, dexamethasone implant). Patients were excluded from receiving FAc if they had a known history of elevated intraocular pressure (IOP) following corticosteroid therapy, glaucoma, ocular hypertension, or any contraindications cited in the summary of product characteristics. Best-corrected visual acuity (BCVA) was the main study parameter. Central fovea thickness (CFT) and IOP were measured concurrently. These parameters were recorded prior to and after the injection of the 190-μg FAc implant (between 1 week and 9 months). Injections were performed between May 2013 and March 2014.
Results:
Fifteen eyes from ten patients were treated. Thirteen eyes (nine patients) were pseudophakic, and seven eyes (five patients) were vitrectomized prior to receiving therapy. BCVA improved in eleven eyes (73.3%), remained unchanged in two eyes (13.3%), and decreased slightly in two eyes (13.3%) at the last follow-up visit versus baseline levels. IOP increased in two patients and was controlled using fixed-combination of IOP-lowering eyedrops or sectorial cyclocryotherapy (n=1).
Conclusion:
The 190-μg FAc implant was efficacious and showed a favorable benefit-to-risk profile in the patient population with chronic DME of this case series that were refractory to other therapies. The longer-term efficacy and safety in a real-life setting is still being assessed in this center. FAc may offer an important treatment option for patients with chronic DME refractory to other treatment options.