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Outlook Therapeutics Reports Completion of Patient Dosing in the ONS-5010 Pivotal Phase 3 NORSE TWO Trial
Topline readout of data from NORSE TWO targeted for calendar Q3 2021New Biologics License Application (BLA) filing anticipated in calendar Q1 2022 ISELIN,
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"Topline readout of data from NORSE TWO targeted for calendar Q3 2021New Biologics License Application (BLA) filing anticipated in calendar Q1 2022 ISELIN, N.J., June 08, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, reported today that it has administered the final dose to the last patient enrolled in its pivotal NORSE TWO safety and efficacy study evaluating ONS-5010 (bevacizumab-vikg) for treatment of wet age-related macular degeneration (wet AMD). Topline data are expected to be reported for NORSE TWO in the third calendar quarter of 2021. The NORSE TWO pivotal Phase 3 clinical trial enrolled a total of 228 wet AMD patients at 39 clinical trial sites in the United States. Patients in the trial are being treated for 12 months. The primary endpoint for the study is the difference in proportion of patients who gain at least 15 letters in the best corrected visual acuity (BCVA) at 11 months for ONS-5010 dosed on a monthly basis, compared to LUCENTIS®, which is being dosed quarterly per the PIER regimen. “We are very pleased to have completed patient dosing and take another step forward in completing our wet AMD clinical program for ONS-5010. On behalf of the Outlook Therapeutics team, I would like to thank the clinicians and participants in the study, whose dedication has made it possible,” said Lawrence A. Kenyon, President, CEO and CFO, Outlook Therapeutics. “We remain on track to report topline data in the third quarter and continue to execute against our plan to advance this much-needed ophthalmic formulation of bevacizumab to market. Following the upcoming data readout, we look forward to our planned new BLA submission for wet AMD in the first quarter of calendar 2022.” ONS-5010 (bevacizumab-vikg) registration clinical trial program The clinical program for the planned ONS-5010 wet AMD BLA consists of three clinical trials: NORSE ONE, a proof-of-concept clinical experience trial in wet AMD patients; NORSE TWO, the pivotal Phase 3 wet AMD trial powered for statistical significance; and NORSE THREE, a supplemental safety study in patients with wet AMD and other retina diseases undertaken to ensure that a sufficient number of patients have been dose...