Vabysmo maintains vision gains in RVO with extended treatment intervals in phase 3 studies
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Key takeaways:
- Vabysmo showed maintenance of vision and anatomic improvements up to week 72 in retinal vein occlusion.
- A treat-and-extend dosing regimen prolonged patients’ treatment interval up to every 4 months.
In the phase 3 BALATON and COMINO studies, Vabysmo demonstrated vision maintenance and anatomic improvements up to week 72 in macular edema secondary to retinal vein occlusion, or RVO, according to a Genentech press release.
In both studies, Vabysmo (faricimab-svoa) was administered from week 24 to week 72 using a treat-and-extend dosing regimen, allowing patients to extend their treatment interval up to every 4 months while maintaining the vision gains achieved at week 24. Consistent reduction in central subfield thickness indicated rapid, robust and sustained drying of retinal fluid from baseline to 72 weeks.
Image: Adobe Stock
“These are the first RVO trials to show vision maintenance and anatomical improvements up to 72 weeks in both central and branch retinal vein occlusion,” Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of global product development, said in the release. “These data further support Vabysmo’s potential as a new treatment for RVO, allowing people to preserve their vision while spending less time managing their condition.”
Data from the BALATON and COMINO studies up to 24 weeks have been submitted to the FDA and the European Medicines Agency, with an FDA decision expected later this year.
RVO would be the third indication for Vabysmo, which is already approved in more than 80 countries for wet age-related macular degeneration and diabetic macular edema.
Editor's note: This article was updated on Oct. 16, 2023, to add a perspective from Arshad Khanani, MD, MA, FASRS.
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