Outlook Therapeutics submits formal dispute resolution request to FDA

Outlook Therapeutics (OTLK) announced that it submitted a formal dispute resolution request to the FDA as a follow-up to its recent Type A meeting regarding the December 30, 2025 Complete Response Letter for the Biologics License Application for ONS-5010, or Lytenava. The FDA has accepted the request and granted a meeting with the deciding official to be conducted in April. The company stated its submission includes a comprehensive presentation of clinical data that it believes supports the efficacy and safety of ONS-5010 for the treatment of neovascular age-related macular degeneration. “We look forward to our discussions with the FDA and remain committed to our position that data on safety and efficacy for LYTENAVA demonstrated in NORSE TWO and NORSE EIGHT provide sufficient evidence to support approval and bring a much-needed FDA approved option for patients,” said Bob Jahr, CEO of Outlook Therapeutics.