Outlook Therapeutics Announces Receipt Of Type A Meeting Official Minutes On ONS-5010 BLA

(RTTNews) - Biopharmaceutical company Outlook Therapeutics, Inc. (OTLK) announced Monday the receipt of the official minutes from the Type A meeting with the U.S. Food and Drug Administration (FDA) held in October 2023.

The type A meeting was 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.

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.

It will also confirms 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 said it 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.