Outlook Therapeutics Announces Receipt of Type A Meeting Minutes and Reiterates Regulatory Path Forward for ONS-5010

• Resubmission of the ONS-5010 BLA on track for the end of calendar year 2024, pending final agreement on a clinical trial protocol with the FDA and successful completion of the required additional clinical trial
• Planned clinical trial expected to be a 3-month non-inferiority study with 60 day efficacy endpoint

ISELIN, N.J., Nov. 27, 2023 (GLOBE NEWSWIRE) -- 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 the receipt of the official minutes from the Type A meeting with the U.S. Food and Drug Administration (FDA) held in October 2023 regarding the Complete Response Letter (CRL) dated August 29, 2023 for the Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.

As previously reported, the FDA requires an additional adequate and well-controlled study to support the ONS-5010 BLA. The FDA has informed Outlook Therapeutics that it can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment naïve patients with a primary endpoint at 2 months. As recommended by the FDA at the Type A meeting, Outlook Therapeutics has been working with the Division of Ophthalmology to design an appropriate study to satisfy the FDA’s requirements. The FDA and Outlook Therapeutics have also identified the approaches needed to resolve the CMC comments in the CRL.

“We are encouraged by the productive discussions we have had with the FDA regarding next steps for our ONS-5010 approval pathway. We continue to believe in the potential of ONS-5010 to address the need here in the United States, as well as globally, for an approved ophthalmic bevacizumab that meets FDA standards for the treatment of wet AMD,” commented Russell Trenary, President and CEO of Outlook Therapeutics.

Based on the October Type A meeting and ongoing informal discussions with the FDA, Outlook Therapeutics has submitted a protocol for review at an upcoming Type A meeting with the FDA in December 2023. Upon confirmation of the protocol details with the FDA, Outlook Therapeutics intends to submit a Special Protocol Assessment (SPA) to memorialize the agreement with the FDA on the trial design and confirm that, if successful, this additional study, in combination with the successful completion of the ongoing work related to the CMC requests in the CRL, would support approval of a resubmitted ONS-5010 BLA. Outlook Therapeutics continues to believe that the proposed clinical trial design as included in the Type A meeting request would allow for completion of the study in 2024 and resubmission of the ONS-5010 BLA by the end of calendar year 2024.