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Outlook Therapeutics Reports Topline Results And Proof-of-Concept For ONS-5010 / LYTENAVA From NORSE 1

ONS-5010, an investigational ophthalmic formulation of bevacizumab-vikg for the treatment of wet AMD, demonstrated safety and efficacy profile consistent with previously published ophthalmic bevacizumab

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  • ONS-5010, an investigational ophthalmic formulation of bevacizumab-vikg for the treatment of wet AMD, demonstrated safety and efficacy profile consistent with previously published ophthalmic bevacizumab research

  • NORSE 1 results support trial design and inclusion criteria for fully enrolled, ongoing pivotal NORSE 2 registration trial

MONMOUTH JUNCTION, N.J., Aug. 26, 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 topline results demonstrating anticipated safety and efficacy and positive proof-of-concept of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD) from its NORSE 1 clinical study, the first of two registration clinical trials.  ONS-5010 is the first injectable ophthalmic formulation of bevacizumab-vikg seeking U.S. Food and Drug Administration (FDA) approval for the treatment of wet AMD under a new Biologics License Application (BLA).

“Although a small study, we are excited to see that both the efficacy signals that we anticipated in NORSE 1 for an ophthalmic bevacizumab as well as the clinical safety data are consistent with previously published results for ophthalmic bevacizumab,” stated Mark Humayun, MD, PhD, Medical Advisor to Outlook Therapeutics. “We are looking forward to seeing the results of the NORSE 2 pivotal trial in the third quarter of 2021. If ONS-5010 is approved to treat wet AMD and other retinal diseases, it will be a significant development in the practice of ophthalmology. Bevacizumab is a well understood anti-VEGF therapy that is already widely used, and ONS-5010, if approved, will be a valuable, FDA-approved treatment option across the spectrum of retinal care.”

In NORSE 1, there were no statistical differences between LUCENTIS® (ranibizumab) and ONS-5010 in the study. Overall, 2 of 25 (8%) patients on the ONS-5010 arm achieved > 15 letters best corrected visual acuity (BCVA) at Month 11 compared to 5 of 23 (22%) patients on the ranibizumab arm. In the subgroup analysis of treatment-naïve subjects, 2 of 6 (33%) patients on the ONS-5010 arm achieved > 15 letters at Month 11 compared to 4 of 13 (31%) patients in the ranibizumab arm. Additionally, the subgroup analysis of patients who had a baseline visual acuity of < 67 letters (20/50 or worse) at study entry included 2 of 4 (50%) patients in the ONS-5010 arm and 4 of 9 (44%) patients in the ranibizumab arm achieving > 15 letters at Month 11. These key subgroups represent the enrollment criteria for patients in the fully enrolled, pivotal NORSE 2 clinical trial.

The results from NORSE 1 indicate that the observed safety profile of ONS-5010 in this study is consistent with that of previously reported bevacizumab ophthalmology studies. There were no statistical differences in safety between LUCENTIS® (ranibizumab) and ONS-5010 in the study and zero cases of ocular inflammation.

“The results from NORSE 1 met our proof-of-concept expectations and, importantly, validate our confidence in the design of our ongoing NORSE 2 trial and the potential data we may see from that study. As anticipated in NORSE 1, ONS-5010 provided us with positive trends in efficacy in three-line visual acuity gains and was shown to be safe and well tolerated. In fact, ONS-5010 had no adverse events associated with inflammation, which has emerged as a concern for other anti-VEGFs in treating retinal diseases,” said Lawrence Kenyon, President, CEO and CFO of Outlook Therapeutics. “On behalf of Outlook Therapeutics, I want to thank all of the patients and clinicians who have persevered through the COVID-19 pandemic to bring this clinical trial to completion.”

The results from NORSE 1 provide support for the established design and protocol for the ongoing pivotal NORSE 2 clinical trial, the second of two registration clinical trials evaluating ONS-5010 for treatment of wet AMD; NORSE 2 excludes patients with vision better than 20/50 at baseline, as well as patients who have received prior treatment for wet AMD. NORSE 2 is powered for statistical significance, and by excluding such patients, Outlook Therapeutics believes that NORSE 2 has enrolled the optimal patients for meeting the endpoint of the study. 

Mr. Kenyon concluded, “With these results now in hand, we turn our attention to our NORSE 2 Phase 3 pivotal trial, which is similar in design to NORSE 1 in length of treatment and dosing, but is designed with a larger, and treatment-naïve, patient population and powered to show statistical significance. Based on our end-of-Phase 2 discussions with the FDA, we believe that the results from NORSE 1 and NORSE 2, combined with our upcoming NORSE 3 safety study that is designed to ensure an adequate number of patient exposures to ONS-5010 are available, will be sufficient to support a new BLA submission in the second half of next year.”

Outlook Therapeutics intends to complete development of ONS-5010 for submission to the FDA as a new BLA under the 351(a) PHSA regulatory pathway for the treatment of wet AMD and also has plans to submit for regulatory approvals in Europe, the United Kingdom and Japan, as well as other countries. While bevacizumab is already widely used, if approved, ONS-5010 will be the first and only on-label ophthalmic formulation of bevacizumab-vikg approved for treating retinal diseases and has the potential to address a $9.1 billion anti-VEGF market.