Because anti-VEGF therapy is already widely established by retinal specialists as the standard of care for retinal diseases, and because FDA-approved anti-VEGF drugs such as LUCENTIS® and EYLEA® are currently so expensive, ONS-5010 has the potential, if approved and commercialized as a responsibly priced, on-label ophthalmic formulation of bevacizumab, to become the anti-VEGF cornerstone of care for treating wet AMD, DME and BRVO.

If approved, ONS-5010 has the potential to become the first-line therapy for anti-VEGF treatment initiation and for maintenance therapy of retinal diseases, based on historical use of anti-VEGF therapies. In second-line treatment scenarios, ONS-5010 may become a synergistic option for combination with premium-priced, approved anti-VEGF drugs or for sustained delivery involving future long-acting agents and other adjunct, non-drug therapies. Outlook Therapeutics intends to work with retinal societies and payors to indicate use of ONS-5010, if approved, in step-edit clinical therapy guidelines for retinal diseases.

If ONS-5010 is approved, Outlook Therapeutics intends to seek reimbursement from CMS for ONS-5010 as the first and only FDA-approved ophthalmic formulation of bevacizumab to be administered as an intravitreal injection for the treatment of wet AMD and, as applicable, other retinal diseases. Under a planned responsible pricing strategy, ONS-5010 has the potential, if approved and commercialized, to help lower the aggregate costs of treating retinal diseases for the overall healthcare system.

About Bevacizumab

Bevacizumab is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (or mAb) that inhibits VEGF and associated angiogenic activity. With wet AMD, abnormally high levels of VEGF are secreted in the eye. VEGF is a protein that promotes the growth of new abnormal blood vessels. Anti-VEGF injection therapy blocks this growth. Since the advent of anti-VEGF therapy, it has become the standard of care treatment option within the retina community globally (National Eye Institute).