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.