New Phase III Data Show Genentech’s Vabysmo Rapidly Improved Vision and Reduced Retinal Fluid in People With Retinal Vein Occlusion (RVO)
Vabysmo met its primary endpoint in two clinical trials, BALATON and COMINO, showing non-inferior visual acuity gains compared to aflibercept
More Vabysmo patients showed an absence of blood vessel leakage
in the retina compared to aflibercept in a pre-specified exploratory endpoint
If approved, RVO would be the third indication for Vabysmo in addition to wet, or neovascular, age-related macular degeneration and diabetic macular edema
Excerpt from the Press Release:
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive new data from two global Phase III studies, BALATON and COMINO,evaluating Vabysmo® (faricimab-svoa) in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO) at 24 weeks. The studies showed that treatment with Vabysmo resulted in early and sustained improvement in vision, meeting the primary endpoint of non-inferior visual acuity gains compared to treatment with aflibercept. Vabysmo also showed rapid and robust drying of retinal fluid from baseline, as measured by reduction in central subfield thickness. The safety profile of Vabysmo was consistent with previous trials. Results will be presented virtually on February 11 at Angiogenesis, Exudation, and Degeneration 2023, organized by Bascom Palmer Eye Institute in Florida.
“These encouraging results reinforce the potential of Vabysmo as a new treatment option for people experiencing vision loss associated with retinal vein occlusion,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “As these positive data continue to accrue, we believe Vabysmo may redefine the standard of care for multiple types of retinal conditions that can cause blindness.”
Wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME), and RVO together affect around three million people in the United States and are among the leading causes of vision loss.
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