Outlook Therapeutics Reports Positive Efficacy and Safety Data from Pivotal Phase 3 NORSE TWO Trial of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the Treatment of Wet AMD

Listen to our conference call with Outlook Therapeutics management to learn more about the pivotal data.

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NEWS

October 12, 2021
Outlook Therapeutics’ Positive NORSE THREE Safety Data Presented at 2021 American Society of Retina Specialists for ONS-5010 Ophthalmic Bevacizumab
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October 7, 2021 Outlook Therapeutics to Present at the 2021 American Society of Retina Specialists (ASRS) Annual Meeting
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Outlook Therapeutics…

…is a late clinical-stage biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME) and branch retinal vein occlusion (BRVO).

ABOUT ONS-5010

ONS-5010/ LYTENAVA™ (bevacizumab-vikg) is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. Bevacizumab is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (or mAb) that inhibits VEGF and associated angiogenic activity.

ONS-5010 has completed the pivotal clinical trial in our Phase 3 program for wet AMD and is expected to be submitted with the FDA as a new BLA for this ophthalmic indication in the first calendar quarter of 2022. Outlook Therapeutics also intends to commence additional clinical trials for ONS-5010 in DME and BRVO.

If approved, ONS-5010 will be the first and only FDA-approved ophthalmic formulation of bevacizumab to treat retinal diseases.