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Outlook Therapeutics Reports Topline Results and Positive Proof-of-Concept for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) 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
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"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 researchNORSE 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).\n “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, t...