If approved, ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab, has the potential to become one of the first-line therapies for anti-VEGF treatment initiation and for maintenance therapy of retinal diseases, based on historical use of anti-VEGF 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.

Note that AETNA™ Medical Solutions issued clinical guidelines in A MEDICAL CLINICAL POLICY BULLETIN, effective January 1, 2020, mandating bevacizumab as first-line step therapy for multiple retinal diseases, including wet AMD and DME, for Medicare PART B patients.

If ONS-5010 is approved, Outlook Therapeutics intends to seek reimbursement from CMS for ONS-5010 / LYTENAVA™ 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 approved, 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).