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.