Outlook Therapeutics Requests Type A Meeting With FDA

ISELIN, N.J., Sept. 29, 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 that a Type A Meeting request has been submitted to 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.

In the FDA’s recently issued CRL, although the Agency acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, it concluded it could not approve the BLA during this review cycle due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence. The Company is committed to working with the FDA to address its concerns.

“Our belief remains unwavering that the retina community needs an FDA-approved ophthalmic bevacizumab to deliver an alternative on-label bevacizumab option for patients with wet AMD. We look forward to a productive meeting with FDA to discuss the CRL with the goal of obtaining a clear understanding of the items that need to be addressed to resubmit our BLA for ONS-5010 at the earliest opportunity,” said Russell Trenary, President and CEO of Outlook Therapeutics.

About Outlook Therapeutics, Inc.

Outlook Therapeutics is a biopharmaceutical company working to achieve FDA approval for the launch of ONS-5010/ LYTENAVA (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. The FDA accepted Outlook Therapeutics’ BLA submission for ONS-5010 to treat wet AMD with an initial PDUFA goal date of August 29, 2023; FDA did not approve the BLA during this review cycle and the Company is working with the FDA to address the issues that have been raised so that the BLA may be re-submitted. The submission is supported by Outlook Therapeutics’ wet AMD clinical program, which consists of three clinical trials: NORSE ONE, NORSE TWO, and NORSE THREE. If ONS-5010 ophthalmic bevacizumab is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan, and other markets. As part of the Company’s multi-year commercial planning process, Outlook Therapeutics and Cencora, formerly AmerisourceBergen, entered into a strategic commercialization agreement to expand the Company’s reach for connecting to retina specialists and their patients. Cencora will provide third-party logistics (3PL) services and distribution, as well as pharmacovigilance services and other services in the United States. For more information, please visit www.outlooktherapeutics.com.