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Outlook Therapeutics Presents Positive NORSE THREE Safety Data for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) at EURETINA Virtual 2021 Medical Conference
ISELIN, N.J., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"ISELIN, N.J., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today 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,” said 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. “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 d...