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Outlook Therapeutics Reports New Positive 12-Month Safety Data from Pivotal Phase 3 NORSE TWO Trial
Full year data reinforce strong safety profile consistent with previous trials of ONS-5010 and with prior published data on ophthalmic bevacizumab Full data
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"Full year data reinforce strong safety profile consistent with previous trials of ONS-5010 and with prior published data on ophthalmic bevacizumab Full data to be presented at American Academy of Ophthalmology’s Retina Subspecialty Meeting, RET13 - Section X: Late Breaking Developments, Part II on November 13th at 9:17 AM ET ISELIN, N.J., Sept. 28, 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 new 12-month safety data from the pivotal Phase 3 NORSE TWO trial that further confirm the strong safety profile in this study of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for treatment of neovascular age-related macular degeneration (wet AMD). In August 2021, Outlook Therapeutics announced the topline readout of pivotal data from its NORSE TWO trial, which included 11 months of safety data. The topline data previously reported from NORSE TWO demonstrated clinically relevant and highly statistically significant results as well as a robust safety profile indicating that in the trial ONS-5010 was well tolerated and showed no unanticipated safety signals. “The full 12-month safety data results move us one step closer to providing patients with an FDA-approved, cGMP-produced drug product that meets ophthalmic FDA standards and avoids the potential risks of repackaged IV bevacizumab,” said C. Russell Trenary III, President and CEO of Outlook Therapeutics. “Our goal is to offer patients, in the United States and globally, a safe and effective, approved ophthalmic bevacizumab. ONS-5010 is specifically formulated to meet requirements to treat retinal diseases like wet AMD. We continue to work towards submitting a Biologics License Application for ONS-5010 to the U.S. Food and Drug Administration for ONS-5010 in the first calendar quarter of 2022.” The NORSE TWO pivotal Phase 3 clinical trial enrolled a total of 228 subjects with wet AMD across 39 clinical trial sites in the United States. Participants in the trial were followed for 12 months. The primary endpoint for the study was the proportion of patients who gained at least 15 letters in the best corrected visual acuity (BCVA) at 11 months. The trial compared ONS-5010 dosed monthly to LUCENTIS®, which was dosed...