A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion
Latest Information Update: 08 Jul 2024
At a glance
- Drugs Faricimab (Primary) ; Aflibercept
- Indications Branch retinal vein occlusion; Retinal oedema
- Focus Registrational; Therapeutic Use
- Acronyms BALATON
- Sponsors Roche
- 04 Jul 2024 According to a Genentech media release, company announced that the U.S. Food and Drug Administration (FDA) has approved the Vabysmo (faricimab-svoa) 6.0 mg single-dose prefilled syringe (PFS) for use in the treatment of wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).
- 28 Jun 2024 According to a Roche media release, based on full 72-week data from the Phase III BALATON and COMINO studies the European Medicines Agencys Committee for Medicinal Products for Human Use has adopted a positive opinion for the extension of the Vabysmo (faricimab) marketing authorisation to include the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO). A final decision regarding the approval is expected from the European Commission in the near future.
- 01 Feb 2024 Results published in the Chugai Pharmaceutical Media Release.