Roche announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) 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). Vabysmo was well tolerated and the safety profile was consistent with previous studies.

Current available treatments for RVO are typically given every one to two months. Vabysmo was first approved for RVO by the United States Food and Drug Administration in October 2023 and by the Japan Ministry of Health, Labour and Welfare in March 2024. It is also approved in more than 95 countries around the world for people living with neovascular or 'wet' age-related macular degeneration (nAMD) and diabetic macular edema (DME).

Roche has the broadest retina pipeline in ophthalmology. Led by science and informed by insights from people with eye conditions, Roche is committed to saving people's eyesight from the leading causes of vision loss through pioneering treatments. Secondary endpoints included change in central subfield thickness and drying of retinal fluid from baseline over time up to week 24.

About the Vabysmo (faricimab) clinical development programme. Roche has a robust Phase III clinical development programme for Vabysmo. The programme includes AVONELLE-X (NCT04777201), an extension study of TENAYA (NCT03823287) and LUCERNE (NCT03823300), evaluating the long-term safety and tolerability of Vabysmo in neovascular or "wet' age-related Macular degeneration (nAMD), and RHONE-X (NCT04432831), an extension study of YOSEMITE (NCT03622580) and RHINE (NCT03622593) evaluating the long-term safety & tolerability of Vabysmmo in diabetic macular edema (DME).

Roche has also initiated several Phase IV studies, including the ELEVATUM (NCT05224102) study of Vabysmo in underrepresented patient populations with DME, the SALWEEN study of Vabysmo In a subpopulation of nAMD highly prevalent in Asia, and the POYANG (NCT06176352) study of Vabys Mo in adult treatment-naive patients with choroidal neovascularisation secondary to pathologic myopia. Roche has also initiated the VOYAGER (NCT05476926) study, a global real-world data collection platform, and supports several other independent studies to further understand retinal conditions with a high unmet need.