Outlook Therapeutics is focused on developing innovative therapies aimed at preserving vision, particularly through its lead product, ONS-5010 (LYTENAVA™), which is an investigational ophthalmic formulation of bevacizumab. This therapy is designed for the treatment of retinal diseases such as wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and branch retinal vein occlusion (BRVO). ONS-5010 is administered via intravitreal injection and functions as a humanized anti-VEGF (Vascular Endothelial Growth Factor) monoclonal antibody, inhibiting VEGF to reduce associated angiogenic activity. The company has conducted several clinical trials, including the pivotal NORSE TWO trial, which demonstrated significant efficacy and safety outcomes, although the FDA issued a Complete Response Letter (CRL) due to manufacturing and regulatory concerns.

In addition to its ongoing efforts to address the FDA's feedback and resubmit the Biologics License Application (BLA) for ONS-5010, Outlook Therapeutics is planning further clinical trials to evaluate the therapy's effectiveness in treating DME and BRVO. The company has established a comprehensive clinical program, including trials like NORSE ONE, NORSE TWO, and NORSE THREE, which have collectively provided a robust safety and efficacy profile for ONS-5010. The anticipated success of these trials is crucial for securing FDA approval, which would grant ONS-5010 a significant marketing exclusivity period as the first FDA-approved ophthalmic formulation of bevacizumab for retinal indications.

United States

Outlook Therapeutics is a late clinical-stage biopharmaceutical company working to develop ONS-5010 / LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010 is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab-vikg for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan and other markets. Outlook Therapeutics expects to file ONS-5010 with the U.S. FDA as a new BLA under the PHSA 351(a) regulatory pathway.

Eye Diseases

Outlook Therapeutics

Eye disease

Wet age-related macular degeneration

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.&nbsp;Because no currently approved ophthalmic formulations of bevacizumab are available, clinicians wishing to treat retinal patients with bevacizumab have had to use unapproved repackaged IV bevacizumab provided by compounding pharmacists, products that have known risks of contamination and inconsistent potency and availability. If approved, ONS-5010 will reduce the need for use of unapproved repackaged IV bevacizumab from compounding pharmacists for retinal disease.
 
ONS-5010 is a full-length, humanized anti-VEGF (Vascular Endothelial Growth Factor) recombinant monoclonal antibody (or mAb) that&nbsp;inhibits VEGF and associated angiogenic activity.&nbsp;VEGF is a protein that promotes the growth of new abnormal blood vessels. With wet AMD, abnormally high levels of VEGF are secreted in the eye and lead to loss of vision. 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.

Outlook Therapeutics

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