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Outlook Therapeutics Submits ONS-5010 Special Protocol Assessment to FDA

Dec 19, 2023

Outlook Therapeutics announced that it has submitted a Special Protocol Assessment (SPA) request to the FDA regarding the required additional adequate and well-controlled study of ONS-5010.  An SPA is a process in which sponsors ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies.

On 27 November 2023, Outlook announced it had a ‘Type A’ meeting with the FDA in October 2023 to discuss the Complete Response Letter (CRL) it received in August 2023 regarding its Biologics License Application (BLA) for ONS-5010.  It stated the FDA said Outlook can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment-naïve patients with a primary efficacy endpoint at 2 months.

The FDA is expected to provide a response to the SPA in early February 2024.