ONS-5010 — Addressing Unmet Medical and Social Needs

There are unmet medical and social needs for a responsibly 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 will help address the quality, safety and availability issues associated with repackaged bevacizumab from compounding pharmacists (e.g., cGMP-quality control issues, product shortages, inconsistent potency, sterility issues and liability risks associated with off-label, unregulated use of repackaged 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. By ensuring the consistent availability of safe, sterile and fully potent on-label bevacizumab for intravitreal injection, at a responsible price, ONS-5010, if approved, has the potential to become the anti-VEGF cornerstone of care for retinal diseases. It may also provide synergies with future long-acting agents and adjunct therapies for advanced treatment of wet AMD, DME and BRVO.

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 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).