USFDAMay 26, 2026, 07:02 AM
Outlook Therapeutics FDA Appeal Granted for LYTENAVA; BLA Resubmission in June
AI Summary
Outlook Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted its appeal following the Formal Dispute Resolution process for ONS-5010/LYTENAVA™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD). The FDA concluded that substantial evidence of effectiveness has been established for LYTENAVA™. As a result, Outlook Therapeutics expects to resubmit the Biologics License Application (BLA) in June 2026, providing a clear path toward U.S. approval for what would be the first FDA-approved ophthalmic formulation of bevacizumab.
Key Highlights
- FDA granted Outlook Therapeutics' appeal for ONS-5010/LYTENAVA™ for neovascular age-related macular degeneration (nAMD).
- FDA concluded that substantial evidence of effectiveness has been established for LYTENAVA™.
- Outlook Therapeutics expects to resubmit the Biologics License Application (BLA) in June 2026.
- The decision followed a Formal Dispute Resolution (FDR) process after a December 30, 2025 Complete Response Letter (CRL).
- The NORSE TWO trial results, supported by NORSE EIGHT and other data, established effectiveness.
- The resubmission is anticipated to be Class 1, with a PDUFA decision expected within 60 days.
- If approved, ONS-5010/LYTENAVA™ would be the first FDA-approved ophthalmic bevacizumab formulation.
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