FDA says cannot approve Outlook Therapeutics ONS-5010 BLA in present form

Outlook Therapeutics (OTLK) announced that the FDA has issued a complete response letter to the ONS-5010/Lytenava 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. In the CRL, the FDA noted that the additional mechanistic and natural history data information provided in the BLA resubmission does not alter the previous review conclusion that while the one adequate and well-controlled study demonstrated efficacy, the FDA has again recommended that confirmatory evidence of efficacy be submitted to support the application, however the FDA has not indicated what type of confirmatory evidence would be acceptable. “Our goal has always been to provide wet AMD patients and their physicians with a safe, consistent, FDA-approved alternative to compounded Avastin manufactured in the United States, and that goal has not changed. We are disappointed and disagree with this decision, but we remain fully committed to taking all necessary steps to receive approval in the United States. We continue to believe strongly in the clinical need and commercial potential of the first on-label bevacizumab product for patients in the United States that is specifically formulated, manufactured, and packaged for intravitreal use,” commented Bob Jahr, CEO of Outlook Therapeutics.