Outlook Therapeutics’ resubmission for wet AMD candidate rejected by FDA

Outlook Therapeutics (OTLK) announced that the FDA has issued a complete response letter, or CRL, to its biologics license application resubmission, indicating that the FDA cannot approve the application in its present form for the treatment of wet age-related macular degeneration, or wet AMD. The CRL included only one deficiency, for a lack of substantial evidence of effectiveness. In the CRL, the FDA advised that, because ONS-5010 did not meet the primary efficacy endpoint in NORSE EIGHT, it is recommended that confirmatory evidence of efficacy be submitted to support the application for ONS-5010. Additionally, the FDA reiterated that NORSE TWO met its primary endpoint for effectiveness. In addition to requesting a meeting with the FDA to explore pathways for potential approval in the U.S., Outlook Therapeutics intends to continue its efforts to expand into additional markets in Europe. As previously announced, lytenava – bevacizumab gamma – was granted Marketing Authorization by the European Commission in the EU and Marketing Authorization by the Medicines and Healthcare products Regulatory Agency in the UK for the treatment of wet AMD. In June 2025, lytenava became commercially available in Germany and the UK for the treatment of wet AMD.