RegulatoryApr 21, 2026, 09:07 AM
Outlook Therapeutics Completes FDA Dispute Resolution Meeting
AI Summary
Outlook Therapeutics announced the completion of its Federal Dispute Resolution (FDR) meeting with the FDA's Office of New Drugs. This meeting was a follow-up to a Complete Response Letter (CRL) received on December 30, 2025, for the Biologics License Application (BLA) of ONS-5010/LYTENAVA™ for neovascular age-related macular degeneration. The company aims to align with the FDA on the regulatory pathway and anticipates receiving formal feedback from the Agency in May 2026.
Key Highlights
- Completed Federal Dispute Resolution meeting with FDA's Office of New Drugs.
- Meeting followed a December 30, 2025, Complete Response Letter for ONS-5010 BLA.
- Seeking alignment with FDA on regulatory pathway for ONS-5010/LYTENAVA™.
- Formal feedback from the FDA is expected in May 2026.