Outlook Therapeutics Completes Patient Enrollment of Open-Label Safety Study for ONS-5010/LYTENAVA (bevacizumab-vikg)

• Full enrollment of 195 subjects in NORSE THREE achieved in less than one month, significantly ahead of schedule
• All planned clinical trials for ONS-5010/LYTENAVA BLA for wet AMD now fully enrolled or completed
• Pivotal data expected in mid-2021 from ongoing, fully enrolled Phase 3 registration trial for ONS-5010 (NORSE TWO) with new BLA filing expected in second half of 2021
  

MONMOUTH JUNCTION, N.J., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced the completion of patient enrollment for its planned open-label safety study evaluating ONS-5010/LYTENAVA (NORSE THREE). Patient enrollment for the study was completed in less than one month, significantly ahead of the planned four-month enrollment schedule.

The open-label safety study enrolled 195 subjects with a range of retinal diseases for which an anti-VEGF drug is a therapeutic option, including wet age-related macular degeneration (AMD), diabetic macular edema (DME) and branch retinal vein occlusion (BRVO). Subjects enrolled in the study are receiving three monthly intravitreal (IVT) doses of ONS-5010/LYTENAVA. The data from this study will be included in the complete data package to support the planned Biologics License Application (BLA) for wet AMD, on schedule for submission to the United States Food and Drug Administration (FDA) in the second half of 2021.

“I am delighted to see the enthusiasm for ONS-5010 that our clinical trial investigators have shown and their ability to rapidly enroll patients. The expedited manner in which enrollment was completed strengthens our confidence that an FDA-approved ophthalmic formulation of bevacizumab represents a significant unmet need in the ophthalmic community,” said Mark Humayun, MD, PhD, Medical Advisor to Outlook Therapeutics.

While unapproved repackaged IV bevacizumab from compounding pharmacies is already widely used in treating retinal diseases, ONS-5010, if approved, will be the first and only on-label ophthalmic formulation of bevacizumab-vikg for the treatment of wet AMD. It will offer a new, approved treatment option for wet-AMD, in the estimated $13 billion global market for anti-VEGF retina therapies.