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Outlook Therapeutics Announces Initiation of Supplemental Open-Label Safety Study for ONS-5010 / LYTENAVA™ (bevacizumab-vikg)
First subjects have been enrolled in supplemental open-label safety studyStudy being conducted to ensure the requisite number of patient exposures to ONS-5010
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"First subjects have been enrolled in supplemental open-label safety studyStudy being conducted to ensure the requisite number of patient exposures to ONS-5010 to support new BLA filing to the FDA in 2021 ONS-5010, an investigational ophthalmic formulation of bevacizumab-vikg for the treatment of wet AMD and other retinal diseases, on track to report pivotal data in mid-2021 from ongoing, fully enrolled Phase 3 registration trial MONMOUTH JUNCTION, N.J., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced the initiation and enrollment of the first patients in its planned supplemental open-label safety study evaluating ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (AMD) (NORSE THREE).\n The open-label safety study is being conducted to ensure that an adequate number of safety exposures to ONS-5010 / LYTENAVA™ (bevacizumab-vikg) are available to support Outlook Therapeutics’ initial Biologics License Application (BLA) filing for wet AMD with the U.S. Food and Drug Administration (FDA). In total, approximately 180 patients with a wide range of different retinal diseases for which an anti-VEGF drug can be used as a therapeutic option, including wet AMD, diabetic macular edema (DME) and branch retinal vein occlusion (BRVO), are expected to be enrolled. Patients in the safety study will receive three doses of ONS-5010 over a three-month period. “The initiation of this open-label safety study, the third clinical trial in our wet AMD program, is an important step in our overall development plan for ONS-5010. This study is intended to ensure that enough patients have been treated with ONS-5010 in our streamlined clinical program to support submission for a new BLA,” said Lawrence Kenyon, President, CEO and CFO of Outlook Therapeutics. “With both this supplemental safety study and our fully enrolled pivotal Phase 3 trial moving towards completion in the first half of 2021, we remain on track to report the full complement of data needed for our new BLA filing for wet AMD in the third quarter of 2021.” The data from this supplemental safety study, the results from a previously completed c...