ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an Investigational Ophthalmic Formulation of Bevacizumab – with potential to address Unmet Medical and Social Needs

There are unmet medical and social needs for a well priced, FDA-approved ophthalmic formulation of bevacizumab to treat retinal diseases.

Outlook Therapeutics is working to meet these needs. If approved and commercialized for ophthalmic use, ONS-5010 has the potential to help address the existing quality, safety and availability issues associated with unapproved repackaged IV bevacizumab from compounding pharmacies (e.g., cGMP-quality control issues, product shortages, inconsistent potency, sterility issues, syringe malfunctions, and liability risks associated with use of unapproved repackaged IV bevacizumab).

Additionally, if ONS-5010 is approved and commercialized, the Company expects to price it responsibly to help mitigate the high cost of on-label treatment for retinal diseases. Both in the United States and globally, the high cost of treating retinal diseases such as wet AMD, DME and BRVO can result in patients receiving an insufficient number of treatments, or potentially no treatment at all.

ONS-5010 has the potential, if approved and commercialized with a responsible pricing strategy, 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).