Outlook Therapeutics Announces FDA Acceptance of Resubmitted Biologics License Application for ONS-5010/LYTENAVA™ (bevacizumab-vikg) as a Treatment for Wet AMD
Outlook Therapeutics announced that the FDA has accepted the resubmitted Biologics License Application for ONS-5010/LYTENAVA for the treatment of wet AMD, assigning it a Class 1 review. The agency set a PDUFA target action date of July 29, 2026, marking the final step toward potential approval for the first FDA-approved ophthalmic formulation of bevacizumab.
Key figures
- Pdufa date
- July 29, 2026
- Review class
- Class 1
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