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Outlook Therapeutics® Announces Presentation of Efficacy and Safety Results from NORSE EIGHT Clinical Trial Evaluating ONS-5010 for the Treatment of Wet AMD
Data presented at Hawaiian Eye and Retina 2025 MeetingResults confirmed that intravitreal ONS-5010 provided early and sustained anatomic improvements, with
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"Data presented at Hawaiian Eye and Retina 2025 MeetingResults confirmed that intravitreal ONS-5010 provided early and sustained anatomic improvements, with steady gains in BCVA and reliable, consistent safetyONS-5010 demonstrated to be non-inferior to Lucentis at 4 and 12 weeksCompany on track for anticipated BLA resubmission in calendar Q1 2025 ISELIN, N.J., Jan. 23, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced the presentation of data from NORSE EIGHT at the Hawaiian Eye and Retina 2025 Meeting being held January 18-24, 2025 in Kauai, HI. As part of the meeting, Baruch D. Kuppermann, MD, PhD, of Gavin Herbert Eye Institute, University of California, Irvine, CA presented the abstract titled, “ONS-5010 (bevacizumab-vikg) versus Ranibizumab for Neovascular Age-related Macular Degeneration: Results from the NORSE-EIGHT Noninferiority Randomized Trial,” highlighting the Company’s recently announced 12-week safety and efficacy results for the NORSE EIGHT clinical trial evaluating ONS-5010 in wet AMD patients. The NORSE EIGHT clinical trial was a randomized, controlled, parallel-group, masked, non-inferiority study of newly diagnosed, wet AMD subjects randomized in a 1:1 ratio to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. Subjects received injections at day 0 (randomization), week 4, and week 8 visits, and returned for a final study visit at week 12. The primary endpoint was mean change in BCVA from baseline to week 8. “The NORSE EIGHT results provide additional evidence to the retina community that ONS-5010 meets the expectations for an ophthalmic formulation of bevacizumab, without the challenges that can arise from using repackaged, off-label formulations available today. The reductions in central retinal thickness observed in the trial confirmed that ONS-5010 reduced fluid in the retina on par with ranibizumab, and I’ve been encouraged with the consistency of this treatment across all NORSE clinical studies,” said Dr. Kuppermann. Key Highlights Mean BCVA at baseline was 58.8 ETDRS letters for the ONS-5010 gro...