05.26.2026

Outlook Therapeutics Wins FDA Appeal for Lytenava, Plans BLA Resubmission in June

Key Takeaways FDA’s Office of New Drugs determined that Outlook Therapeutics has established substantial evidence of effectiveness for Lytenava in treating wet AMD, clearing the way for a BLA resubmission in June 2026 The resubmission is expected to be classified as a Class 1 review, with a potential FDA decision anticipated within 60 days after the agency receives the application If approved, Lytenava would become the first FDA-approved ophthalmic formulation of bevacizumab for retinal diseases in the US After several setbacks, Outlook Therapeutics announced Tuesday that the FDA has granted the company’s appeal following a Formal Dispute Resolution (FDR) process tied to its biologics license application (BLA) for ONS-5010/Lytenava (bevacizumab-vikg), a proposed treatment for wet age-related macular degeneration (AMD). The FDA’s Office of New Drugs (OND) concluded that Outlook Therapeutics has established “substantial evidence of effectiveness” for Lytenava in treating wet AMD, a major milestone that clears the way for the company to resubmit its BLA in June 2026.