If approved, ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab, 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. With an enhanced safety and cost-effectiveness profile, Outlook Therapeutics anticipates that ONS-5010, if approved, will be widely adopted by payors and clinicians worldwide.

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, for other retinal diseases. Under a planned 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-vikg is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection the binding of bevacizumab-vikg to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina. Since the advent of anti-VEGF therapy, it has become the standard-of-care treatment option within the retina community globally (National Eye Institute).