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.
ONS-5010 has completed the pivotal clinical trial in our Phase 3 program for wet AMD and is expected to be submitted with the FDA as a new BLA for this ophthalmic indication in the first calendar quarter of 2022. Outlook Therapeutics also intends to commence additional clinical trials for ONS-5010 in DME and BRVO.
If approved, ONS-5010 will be the first and only FDA-approved ophthalmic formulation of bevacizumab to treat retinal diseases.