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.
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