CHMP positive for Vabysmo (faricimab) marketing authorisation to include the treatment of visual impairment due to macular edema secondary to retinal vein occlusion – Roche

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). A final decision regarding the approval is expected from the European Commission in the near future.

“This CHMP recommendation represents an important step towards bringing Vabysmo to even more patients living with vision loss in Europe,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Recognising the disruptive impact retinal vein occlusion can have on the everyday lives and independence of these patients, we hope that Vabysmo will offer a new treatment option that can effectively help preserve and improve their vision.”

The CHMP decision is based on full 72-week data from the Phase III BALATON and COMINO studies evaluating Vabysmo in more than 1,200 people with macular edema due to branch and central RVO (BRVO and CRVO).In both studies, Vabysmo demonstrated early and sustained vision improvements non-inferior to aflibercept, and robust retinal drying. Vabysmo was well tolerated and the safety profile was consistent with previous studies.3 Current available treatments for RVO are typically given every one to two months.

Vabysmo was first approved for RVO by the FDA 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).