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Kala Pharmaceuticals Announces Statistically Significant Results for Primary and Key Secondary Endpoints in STRIDE 3 Clinical Trial Evaluating EYSUVIS™ for Signs and Symptoms of Dry Eye Disease
– STRIDE 3 Met Both Prespecified Primary Efficacy Endpoints, Ocular Discomfort Severity in the Overall ITT Population and in ITT Patients with More Severe
About this update from Kala Bio, Inc.
[{"type":"text","content":"\n– STRIDE 3 Met Both Prespecified Primary Efficacy Endpoints, Ocular Discomfort Severity in the Overall ITT Population and in ITT Patients with More Severe Baseline Discomfort –\n– STRIDE 3 Met Key Sign Endpoint of Conjunctival Hyperemia –\n– Data Enables EYSUVIS NDA Resubmission in 2Q 2020 –\n– Potential Approval and Launch by Year-End 2020 –\n– Conference Call and Webcast Today at 8:00 a.m. ET –\n\n WATERTOWN, Mass.--(BUSINESS WIRE)--\nKala Pharmaceuticals, Inc. (Kala) (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced positive topline results from STRIDE 3, a Phase 3 clinical trial evaluating KPI-121 0.25%, which Kala plans to commercialize under the brand name EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25%, for the treatment of dry eye disease. STRIDE 3 met both of its primary efficacy endpoints, demonstrating a statistically significant improvement in the symptom endpoint of ocular discomfort severity (ODS) at day 15 in the overall intent-to-treat (ITT) population (p=0.0002) and in the predefined subgroup of ITT patients with more severe ocular discomfort at baseline (p=0.0007). Statistical significance was also achieved in the key secondary endpoints of conjunctival hyperemia at day 15 in the ITT population (p","length":1570,"tagName":"div"}]