FDA accepts supplemental biologics license application for Vabysmo
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Key takeaways:
- The FDA accepted a supplemental biologics license application for Vabysmo for the treatment of macular edema following RVO.
- Vabysmo demonstrated positive results in visual improvement and the drying of retinal fluid.
The FDA has accepted a supplemental biologics license application from Genentech for Vabysmo for the treatment of macular edema following retinal vein occlusion, according to a company press release.
“If approved, Vabysmo will provide patients and the retina community with a new treatment option for RVO that has demonstrated early and sustained improvement in vision, as well as rapid and robust drying of retinal fluid,” Jeffrey R. Willis, MD, PhD, global development leader of ophthalmology at Genentech, told Healio/OSN.
The application is supported by positive data from the phase 3 BALATON and COMINO studies, which compared Vabysmo (faricimab-svoa) with aflibercept, according to the release.
Additionally, the two phase 3 studies demonstrated that “more Vabysmo patients had an absence of macular leakage compared with aflibercept as seen in a prespecified exploratory endpoint,” Willis said.
Vabysmo is currently approved for indications of wet age-related macular degeneration and diabetic macular edema.
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