ONS-5010 — Potential First On-Label Bevacizumab for Ophthalmic Indications

Despite clinicians’ widespread acceptance and use of bevacizumab to treat ophthalmic diseases such as wet AMD, DME and BRVO, no manufacturer has previously sought approval from FDA of bevacizumab for these purposes.

Outlook Therapeutics is developing ONS-5010 as an investigational ophthalmic formulation of bevacizumab for a new BLA filing. If approved, ONS-5010 will be the first and only FDA-approved on-label, responsibly priced bevacizumab approved for ophthalmic indications.

If approved by the FDA, ONS-5010 will expand clinicians’ treatment options across the spectrum of ophthalmic drugs for wet AMD, DME and BRVO. As an FDA-approved product, it will bring many advantages:

Safety & efficacy

Sterility from cGMP manufacturing

Approved labeling

Single use vials and pre-filled syringes

Consistent potency

Consistent availability

The Company’s Phase III clinical program design for ONS-5010 was reviewed and agreed upon by FDA in an end-of-Phase-2 (EOP2) meeting in April 2018. Outlook Therapeutics is currently evaluating ONS-5010 in two adequate and well-controlled registration clinical trials vs. an alternate dosing regimen of ranibizumab (LUCENTIS®) for wet AMD (NORSE 1 and 2). The Company also intends to initiate registration studies for approvals in diabetic macular edema (DME, NORSE 5 and 6) and branch retinal vein occlusion (BRVO, NORSE 4). The Company expects to file the investigational compound with the FDA as a new BLA for the treatment of exudative age-related macular degeneration (wet AMD).

Outlook Therapeutics expects to establish responsible pricing for ONS-5010, if approved. If approved for marketing, ONS-5010 has the potential 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).