Genentech, a member of the Roche Group (RHHBY), said that the U.S. Food and Drug Administration has accepted the company's supplemental Biologics License Application or sBLA for Vabysmo (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion or RVO.
The application is based on results from the Phase III BALATON and COMINO studies that demonstrated treatment with Vabysmo provided early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept. Vabysmo's safety profile was consistent with previous trials.
If approved, retinal vein occlusion or RVO would be the third indication for Vabysmo in addition to wet age-related macular degeneration (AMD) and diabetic macular edema (DME).
Vabysmo is currently approved in 60 countries to treat wet AMD and DME, with nearly one million doses distributed globally.
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April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.