The company announced a 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.
Outlook Therapeutics Inc announced the receipt of the official minutes from the Type A meeting with the FDA held last month regarding the Complete Response Letter (CRL) dated August 29, 2023, for the Biologics License Application (BLA) for ONS-5010.
According to the company, ONS-5010 is 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.1
Russell Trenary, president and CEO of Outlook Therapeutics, said in the news release the company has been encouraged by the productive discussions it has had with the FDA regarding next steps for its 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,” Trenary added.
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 next month.1
According to the company’s news release, upon confirmation of the protocol details with the FDA, it intends to submit a Special Protocol Assessment (SPA) to memorialize the agreement with the FDA on the trial design and confirm that, if successful, the 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.
The company concluded in its news release 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.