ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an Investigational Ophthalmic Formulation of Bevacizumab: Potential First On-Label Bevacizumab for Ophthalmic Indications

Despite clinicians’ widespread acceptance and off-label use of intravenous (IV) repackaged bevacizumab to treat ophthalmic diseases such as wet AMD, DME and BRVO, no other manufacturer has previously sought approval from the FDA of bevacizumab for these purposes.

Outlook Therapeutics is developing ONS-5010 / LYTENAVA™ 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 and responsibly priced bevacizumab approved for approved ophthalmic indications, and will expand clinicians’ treatment options across the spectrum of ophthalmic drugs for wet AMD, DME and BRVO.

The Company’s Phase 3 clinical program design for ONS-5010 was reviewed and agreed upon by the FDA in an end-of-Phase 2 (EOP2) meeting in April 2018. Outlook Therapeutics is currently evaluating ONS-5010 in two registration clinical trials vs. an alternate dosing regimen of ranibizumab (LUCENTIS®) for wet AMD (NORSE 1 and NORSE 2).

The Company also intends to initiate registration studies for approvals in diabetic macular edema (DME, NORSE 5 and NORSE 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).