Outlook Therapeutics Wins Appeal Following Formal Dispute Resolution Process for ONS-5010/LYTENAVA™ (bevacizumab-vikg)
The FDA granted Outlook Therapeutics' appeal following the Formal Dispute Resolution process, concluding that substantial evidence of effectiveness has been established for LYTENAVA in treating neovascular age-related macular degeneration. This decision reverses the December 2025 Complete Response Letter and directs the FDA divisions to work with the company on final labeling, clearing the path for a Class 1 resubmission of the Biologics License Application in June 2026.
Key figures
- Drug Name
- LYTENAVA (bevacizumab-vikg)
- Phase Of Trial
- NORSE TWO, NORSE EIGHT
- Resubmission date
- June 2026
- Pdufa decision window
- 60 days
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