[Ad hoc announcement pursuant to Art. 53 LR] FDA approves Roche ’s Vabysmo for the treatment of retinal vein occlusion (RVO)

RVO is the third indication for Vabysmo, in addition to neovascular or ‘wet’ age-related macular degeneration and diabetic macular edemaApproval is based on two phase III studies demonstrating early and sustained vision improvements that were non-inferior to afliberceptVabysmo also demonstrated rapid and robust drying of retinal fluidAdditional U.S. label update across indications includes information on rare post-marketing reports of retinal vasculitis and/or retinal vascular occlusion; reporting rate isin line withother broadly used intravitreal treatmentsBasel, 27 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the United States Food and Drug Administration (U.S. FDA) has approved Vabysmo ® (faricimab) for the treatment of macular edema following retinal vein occlusion (RVO). RVO is the third indication for Vabysmo, in addition to neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME).1 Together, the three retinal conditions affect around 70 million people worldwide and are among the leading causes of vision loss.2-5“Vabysmo is a new treatment option for RVO that can help people preserve and improve their vision, with the added benefit of retinal drying,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The efficacy and safety profile of Vabysmo has been well established in global clinical trials and is reinforced by a growing breadth of rea...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news