Outlook Therapeutics Presents Positive NORSE THREE Safety Data for Lytenava (bevacizumab-vikg)
Outlook Therapeutics announced the presentation of safety data from the NORSE THREE trial evaluating ONS-5010/Lytenava (bevacizumab-vikg) at the EURETINA Virtual 2021 conference on September 12, 2021. The previously announced topline results from the open-label safety study demonstrated that ONS-5010 ophthalmic bevacizumab, under evaluation for the treatment of wet AMD, showed no unexpected safety trends and had a safety profile consistent with that of prior published data undertaken by the National Eye Institute (2011 CATT trial).
“ONS-5010 has the potential to close the gap on a high unmet need for patients and retinal clinicians,” Professor Timothy L. Jackson, PhD, MB ChB FRCOphth, Ophthalmic and Retinal Surgeon and Professor of Retinal Research at King’s College London and data presenter at EURETINA, said in a company news release. “If approved, ONS-5010 ophthalmic bevacizumab may improve clinical outcomes of patients with wet AMD while potentially avoiding serious adverse events associated with off-label repackaging of IV bevacizumab, including variability in potency, eye infections and loss of sight.”
The NORSE THREE study was conducted to ensure an adequate number of patients with wet AMD and other retinal diseases had been dosed with ONS-5010 to support Outlook Therapeutics’ planned new biologics license application (BLA) submission in the United States and for other global regulatory filings. The open-label study met its goal of ensuring that a sufficient number of individuals have now been treated with ONS-5010 by enrolling 197 treatment-naïve and previously treated subjects with a range of retinal diseases for which an anti-VEGF drug is a therapeutic option, including wet AMD, diabetic macular edema (DME) and branch retinal vein occlusion (BRVO). Subjects enrolled in the study received three monthly intravitreal doses of ONS-5010 ophthalmic bevacizumab.
“ONS-5010 has been rigorously tested to support our efforts to provide the first approved ophthalmic formulation of bevacizumab,” said C. Russell Trenary III, President and Chief Executive Officer, Outlook Therapeutics. “With the trial data and market insight seen to date, we believe ONS-5010 has the potential to become the cornerstone of care for multiple retinal indications and we look forward to working closely with the U.S. Food and Drug Administration and other global regulatory authorities toward our goal of bringing this important therapy to market.”
Outlook Therapeutics’ wet AMD ONS-5010 clinical program for the planned BLA submission consists of three clinical trials, NORSE ONE, NORSE TWO, and NORSE THREE, all of which have now been completed. Most recently, Outlook Therapeutics reported positive topline data from its NORSE TWO pivotal phase 3 clinical trial. In NORSE TWO, ONS-5010 achieved statistically significant and clinically relevant primary (P=0.0052) and key secondary (P=0.0043) efficacy endpoints with 41% of subjects gaining at least 15 letters of BVCA. ONS-5010 was also found to be safe and well tolerated in the NORSE TWO trial.
With the registration clinical trials now completed, Outlook Therapeutics plans to submit a new BLA under the Public Health Service Act (PHSA) 351(a) regulatory pathway in the first quarter of calendar 2022. If the BLA is approved, it is expected to result in 12 years of marketing exclusivity for ONS-5010 as the first and only ophthalmic formulation of bevacizumab approved by the FDA to treat wet AMD.