Outlook Therapeutics Provides Update on Type A Meetings with FDA for Wet AMD Product Candidate

Outlook Therapeutics announced that it has completed the requested Type A Meetings with the 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.

In the August CRL, the FDA acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, however Outlook stated that the FDA could not approve the BLA during that review cycle due to 'several CMC issues, open observations from preapproval manufacturing inspections, and a lack of substantial evidence. At that time, the FDA infomred Outlook that an additional adequate and well-controlled clinical trial would be required for the approval of ONS-5010 (Lytenava) 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, according to an Outlook news release. The FDA and Outlook also agreed on the approaches needed to resolve the CMC comments in the CRL and Outlook 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.