FDA Approves VABYSMO (faricimab) for Retinal Vein Occlusion

On October 26, 2023, Genentech, a member of the Roche Group, announced that the FDA approved VABYSMO (faricimab-svoa) for the treatment of macular edema following retinal vein occlusion (RVO). RVO is the third indication approved for VABYSMO, in addition to wet, or neovascular, age-related macular degeneration (AMD) and diabetic macular edema (DME). Together, the three retinal conditions are among the leading causes of vision loss.

VABYSMO is the first and only bispecific antibody approved for the eye. The FDA’s approval for treatment of RVO is based on positive results from the global Phase III BALATON and COMINO studies that demonstrated monthly treatment with VABYSMO provided early and sustained improvement in vision in people with branch and central RVO, meeting the primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept.