Outlook Therapeutics completes Federal Dispute Resolution meeting with FDA

Outlook Therapeutics (OTLK) announced that it has completed its Federal Dispute Resolution meeting with the Office of New Drugs at the U.S. Food and Drug Administration. The meeting was conducted as part of the Company’s ongoing efforts to seek alignment with the FDA regarding the regulatory pathway for ONS-5010 / LYTENAVA and as a follow-up to its recent Type A meeting with the Division of Ophthalmology and Office of Specialty Medicine regarding the December 30, 2025 Complete Response Letter, CRL, for the Biologics License Application, BLA, for ONS-5010/LYTENAVA for the treatment of neovascular age-related macular degeneration. “We appreciate the opportunity to engage in constructive dialogue with the FDA through the FDR process,” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “We believe this meeting represents an important step in advancing our regulatory strategy, and we look forward to receiving formal feedback from the Agency in May 2026. Outlook Therapeutics remains committed to working collaboratively with the FDA to establish a clear path forward toward potential U.S. approval.”