Aug 28, 12:18 PM

FDA Rejects Outlook Therapeutics’ Wet AMD Drug on Efficacy Concerns

The U.S. Food and Drug Administration has issued a Complete Response Letter to Outlook Therapeutics, saying it cannot approve the company’s resubmitted biologics licence application for ONS-5010/LYTENAVA, an ophthalmic formulation of bevacizumab for wet age-related macular degeneration. The agency cited a lack of "substantial evidence of effectiveness," noting that the pivotal NORSE EIGHT study failed to meet its primary efficacy endpoint even though the earlier NORSE TWO study succeeded. No other deficiencies were raised, but the FDA recommended confirmatory evidence, likely requiring additional clinical work and delaying any U.S. launch. Outlook Therapeutics said it will request a meeting with regulators to clarify next steps. The setback wiped roughly 64 % off the company’s share price in pre-market trading on Thursday. The rejection contrasts with the therapy’s progress in Europe, where LYTENAVA already holds marketing authorisations from the European Commission and the U.K. Medicines and Healthcare products Regulatory Agency. Commercial sales began in Germany and the United Kingdom in June 2025, positioning the product as the first authorised ophthalmic bevacizumab formulation for wet AMD in those markets.

#FDA #Outlook Therapeutics #Europe #European Commission #Germany #United Kingdom #AMD

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FDA Rejects Outlook Therapeutics’ Wet AMD Drug on Efficacy Concerns

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