Outlook Update on Type A Meetings with FDA

  Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that it has completed the requested Type A Meetings with the U.S. Food and Drug Administration (FDA) to discuss the Complete Response Letter (CRL) dated August 29, 2023 regarding the Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.

The FDA informed Outlook Therapeutics that an additional adequate and well-controlled clinical trial would be required for the approval of ONS-5010 for the treatment of wet AMD. During the meetings, Outlook Therapeutics reached an agreement in principle with the FDA on a clinical trial design that would most likely allow for the resubmission of the ONS-5010 BLA as early as the end of calendar year 2024, and subsequent approval around mid-2025, pending final agreement on a clinical trial protocol with the FDA and successful completion of the required additional clinical trial. The FDA and Outlook Therapeutics also agreed on the approaches needed to resolve the CMC comments in the CRL and Outlook Therapeutics believes these efforts should be sufficient to support approval.

“We are confident that we can meet the additional requirements that the FDA is requiring for approval of ONS-5010. The retina community of patients, physicians and payers are all in need of an FDA-approved bevacizumab that meets ophthalmic standards for the treatment of wet AMD, and we remain focused on achieving this critical treatment option,” said Russell Trenary, President and CEO of Outlook Therapeutics.

https://www.globenewswire.com/news-release/2023/11/02/2772275/0/en/Outlook-Therapeutics-Provides-Update-on-Type-A-Meetings-with-FDA.html