Vabysmo Receives CHMP Recommendation for RVO Indication

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 Vabysmo (faricimab) marketing authorization to include the treatment of visual impairment caused by macular edema secondary to retinal vein occlusion (RVO). Vabysmo was developed by Genentech, a member of the Roche Group.

Roche stated a final decision regarding the approval is expected from the European Commission "in the near future."

According to Roche, the CHMP decision is based on full 72-week data from the phase 3 BALATON and COMINO studies evaluating Vabysmo in more than 1,200 people with macular edema caused by branch RVO and central RVO. The company reported that in both studies, Vabysmo demonstrated early and sustained vision improvements noninferior to aflibercept, and robust retinal drying. 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, noted the press release.

Vabysmo was first approved for RVO by the FDA in October 2023 and by Japan’s Ministry of Health, Labor, and Welfare in March 2024. It is also approved in more than 95 countries around the world for patients with wet age-related macular degeneration (AMD) and diabetic macular edema (DME).