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Friday, October 27, 2023

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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