On 21 July 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Vabysmo, intended for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular oedema (DME). The applicant for this medicinal product is Roche Registration GmbH. Faricimab was approved for medical use in the European Union in September 2022. Names Faricimab is the International Nonproprietary Name (INN). Faricimab was formerly named RG7716. Research Neovascular age-related macular degeneration Two phase II trials evaluated faricimab's efficacy and safety in comparison to ranibizumab and showed that faricimab received every 16 weeks and every twelve weeks was comparable to ranibizumab received every four weeks in visual acuity and imaging outcomes. In 2019, two phase III multi-center randomized studies were initiated on 1200 participants with neovascular age related macular degeneration (nAMD) to evaluate faricimab's safety, efficacy, and durability against aflibercept. Diabetic macular edema One phase II trial evaluated faricimab's efficacy and safety in comparison to ranibizumab and showed clinically meaningful and statistically significant improvements in visual acuity. Two phase III multi-center randomized studies were completed on 1,891 diabetic participants with diabetic macular edema (DME) Branch and central retinal vein occlusion macular edema In two phase III trials, faricimab met the primary endpoint of non-inferior visual acuity gains when compared with aflibercept in 553 participants with macular edema due to branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO) in the BALATON and COMINO studies. References External links Angiogenesis inhibitors Genentech brands Hoffmann-La Roche brands Monoclonal antibodies Ophthalmology drugs