…is a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME) and branch retinal vein occlusion (BRVO).
ONS-5010 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 is currently being evaluated in our Phase 3 program for wet AMD and is expected to be filed with the FDA as a new BLA for this ophthalmic indication. Outlook Therapeutics also intends to commence additional clinical trials for ONS-5010 in DME and BRVO. The INN for ONS-5010 is bevacizumab-vikg.
If approved, ONS-5010 will be the first and only FDA-approved ophthalmic formulation of bevacizumab to treat retinal diseases.