ONS-5010/ LYTENAVA™ (bevacizumab-vikg) is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Bevacizumab is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (or mAb) that inhibits VEGF and associated angiogenic activity.
The U.S. Food and Drug Administration, which had accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for review for ONS-5010 to treat wet AMD, issued a Complete Response Letter (CRL) on the PDUFA date of October 27, 2022. 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 registration clinical program, which consists of three clinical trials: NORSE ONE, NORSE TWO, and NORSE THREE. The BLA that Outlook Therapeutics submitted is under the Public Health Service Act (PHSA) 351(a) regulatory pathway. If the BLA is approved, it is expected to result in 12 years of marketing exclusivity for ONS-5010 as the first and only ophthalmic formulation of bevacizumab approved by the FDA to treat wet AMD.
Outlook Therapeutics also intends to commence additional clinical trials for ONS-5010 in DME and BRVO following approval for wet AMD.