Outlook Therapeutics is a biopharmaceutical company working to develop and launch 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 had accepted Outlook Therapeutics’ BLA submission for ONS-5010 to treat wet AMD on October 27, 2022, and issued a Complete Response Letter (CRL) on the PDUFA goal date of August 29, 2023. While the FDA acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, the Agency 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. Outlook Therapeutics is working closely with the FDA to address the Agency’s concerns so that the BLA can be re-submitted for approval. The Company will request a Type A meeting as soon as possible to discuss the CRL and determine potential paths forward for the approval of ONS-5010 for the treatment of wet AMD. 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, and in anticipation of potential FDA approval, Outlook Therapeutics and Cencora, formerly AmerisourceBergen, have 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 and other services in the United States.
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