FDA Approves Genentech’s Vabysmo for the Treatment of Retinal Vein Occlusion
- RVO is the third indication for Vabysmo, in addition to wet, or neovascular, age-related macular degeneration and diabetic macular edema
- Approval is based on two Phase III studies demonstrating early and sustained vision improvements that were non-inferior to aflibercept
- Vabysmo also demonstrated rapid and robust drying of retinal fluid
- Additional U.S. label update across indications includes information on rare post-marketing reports of retinal vasculitis and/or retinal vascular occlusion; reporting rate is in line with other broadly used intravitreal treatments
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