Outlook Therapeutics requests Type A Meeting with FDA

Outlook Therapeutics announced that a Type A Meeting request has been submitted to the U.S. Food and Drug Administration to discuss the Complete Response Letter dated August 29, 2023 regarding the Biologics License Application for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. In the FDA’s recently issued CRL, although the Agency acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, it concluded it could not approve the BLA during this review cycle due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence. “Our belief remains unwavering that the retina community needs an FDA-approved ophthalmic bevacizumab to deliver an alternative on-label bevacizumab option for patients with wet AMD. We look forward to a productive meeting with FDA to discuss the CRL with the goal of obtaining a clear understanding of the items that need to be addressed to resubmit our BLA for ONS-5010 at the earliest opportunity,” said Russell Trenary, President and CEO of Outlook Therapeutics.