Roche eye drug vamikibart accepted for FDA review

12. Oct 2026

(AWP Alliance News) - Roche Holding AG - Basel, Switzerland-based pharmaceutical company - Announces that the US Food & Drug Administration accepts its biologics license application for vamikibart for the treatment of the inflammatory eye condition uveitic macular edema. Says vamikibart "demonstrated sustained improvements in vision and reductions in macular thickness" in adult patients at 52 week in the phase three Meerkat and Sandcat studies. Around 20% of UME patients progress to sustained blindness within three-years of diagnosis. "The acceptance of our application by the FDA and other regulatory bodies around the world brings us closer to offering a transformative, non-steroid therapy for people living with this sight-threatening condition," says Levi Garraway, chief medical officer and head of Global Product Development. The FDA acceptance was based on the findings of both studies and the regulator is expected to make a decision on approval by July 2027.

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By Elijah Dale, Alliance News senior reporter Asia-Pacific

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