Outlook Therapeutics wins FDA appeal for eye drug application

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Outlook Therapeutics Wins Appeal Following Formal Dispute Resolution Process for ONS-5010/LYTENAVA™ (bevacizumab-vikg)

May 26, 2026 7:00 AM EDT

Company plans to resubmit BLA to the FDA in June 2026

ISELIN, N.J., May 26, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA (bevacizumab-vikg, bevacizumab gamma) for the treatment of retinal diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted the appeal... More