Outlook Therapeutics Completes Patient Enrollment of Open-Label Safety Study for Lytenava for Retinal Diseases

Outlook Therapeutics 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 1 month, ahead of the planned 4-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 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,” Mark Humayun, MD, PhD, Medical Advisor to Outlook Therapeutics, said in a company news release.

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.

“On behalf of the entire Outlook Therapeutics team, I would like to express our deep appreciation to the dedicated clinicians conducting this safety study as part of our ONS-5010 registration program,” said Lawrence Kenyon, President, CEO and CFO, Outlook Therapeutics. “The speed with which we completed enrollment in this safety study tells us a lot about the confidence of physicians and patients in ONS-5010. We believe that we remain well-positioned to file a new BLA for wet AMD as planned in 2021, now that all three of the planned clinical trials have either been completed or are fully enrolled.”

In addition to the planned BLA filing in the United States, Outlook Therapeutics is also engaged with regulatory authorities in Europe and other major markets for anticipated approvals in those markets. Outlook Therapeutics also intends to initiate registration clinical trials for ONS-5010 for DME and BRVO.

Commercial launch planning for ONS-5010, including distribution, physician and patient outreach, key opinion leader support and payor community engagement, remains ongoing. With an enhanced safety and cost-effectiveness profile, Outlook Therapeutics expects ONS-5010, if approved, to be widely adopted by payors and clinicians worldwide and to become the first-line drug of choice for payor-mandated “step edit” in the United States for retina indications. Outlook Therapeutics is also engaged with several life sciences companies that could result in a strategic partnership and definitive agreement for ONS-5010 as soon as the end of 2020.