FDA accepts application for Roche ’s Vabysmo for the treatment of retinal vein occlusion (RVO)

Acceptance based on two phase III studies that demonstrated early and sustained vision improvement with Vabysmo, meeting primary endpoint of non-inferiority compared to afliberceptApplication was further supported by data showing Vabysmo achieved rapid and robust drying of retinal fluidIf approved, RVO would be the third indication for Vabysmo in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME)Vabysmo is currently approved in 60 countries to treat nAMD and DME, with nearly one million doses distributed globallyBasel, 9 May 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company ’s supplemental Biologics License Application (sBLA) for Vabysmo® (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO). The sBLA 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.1,2 Vabysmo ’s safety profile was consistent with previous trials.“This acceptance brings us one step closer to delivering Vabysmo as a treatment for retinal vein occlusion, a disease that affects more than one million people in the United States and can cause severe and sudden vision loss,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medic...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news