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Outlook Therapeutics Receives FDA Agreement for Three Special Protocol Assessments for Additional Planned Clinical Trials of ONS-5010
ONS-5010, an investigational ophthalmic formulation of bevacizumab for retinal indications, is currently in two clinical trials to treat wet age-related
About this update from Outlook Therapeutics, Inc.
[{"type":"text","content":"ONS-5010, an investigational ophthalmic formulation of bevacizumab for retinal indications, is currently in two clinical trials to treat wet age-related macular degeneration (wet AMD – NORSE 1 and 2). SPAs for clinical trial protocols for NORSE 4 for branch retinal vein occlusion (“BRVO”) and NORSE 5 and NORSE 6 for diabetic macular edema (“DME”) indicate FDA agreement on overall protocol design (entry criteria, dose selection, endpoints and planned analyses). CRANBURY, N.J., Dec. 03, 2019 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the “Company”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that it has received agreement from the U.S. Food and Drug Administration (“FDA”) on three Special Protocol Assessments (“SPAs”) for three additional registration clinical trials for its ongoing Phase 3 program for ONS-5010, an investigational ophthalmic formulation of bevacizumab. The agreements reached with the FDA on these SPAs cover the protocols for NORSE 4, a registration clinical trial to treat BRVO, and NORSE 5 and NORSE 6, two registration clinical trials to treat DME. Outlook Therapeutics intends to initiate NORSE 4, 5 and 6 in 2020.\n “We are very pleased to reach these agreements with the FDA so that we can continue to build clinical data for additional retinal indications beyond wet AMD for ONS-5010,” said Lawrence A. Kenyon, President, Chief Executive Officer and Chief Financial Officer. “Anti-VEGF therapy has been the standard of care for years within the retinal community for wet AMD, DME and BRVO, and we hope that ONS-5010 will become the first FDA-approved bevacizumab indicated for these diseases. An on-label bevacizumab would enable clinicians to treat their retinal patients with a well-established therapy, and FDA approval would ensure sterility, potency and accurate, safe syringes for intravitreal injections.” “The Outlook Therapeutics team truly cares about improving the clinical landscape for retinal patients, and I want to commend our clinical team for the tremendous dedication they have shown in advancing our Phase 3 program for ONS-5010,” added Terry J. Dagnon, Chief Operating Officer. “ONS-5010, if approved, has the potential to help address the unmet medical needs o...