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 accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for review for ONS-5010 to treat wet AMD on October 27, 2022. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2023. 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.
With the registration clinical trials completed, Outlook Therapeutics submitted a new BLA 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 regulatory 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.