Roche Vabysmo gets CHMP recommendation for third indication retinal vein occlusion

“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. 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. 

Read also: Roche unveils new analytical units for cobas pro integrated solutions in countries accepting CE mark