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Aldeyra Therapeutics Announces Positive Top-Line Symptom and Sign Results from Run-In Cohort of Phase 3 TRANQUILITY Trial in Dry Eye Disease
Statistical Significance of Reproxalap Over Vehicle Achieved for Ocular Redness, an FDA-Approvable Sign, and Clinical Symptoms of Ocular Dryness and
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":"\n\nStatistical Significance of Reproxalap Over Vehicle Achieved for Ocular Redness, an FDA-Approvable Sign, and Clinical Symptoms of Ocular Dryness and Discomfort\n\n\nAcute Improvement in Ocular Redness and Symptom Scores Demonstrated Within Minutes of Reproxalap Administration in Dry Eye Chamber\n\n\nMain Cohort of TRANQUILITY Expected to Begin Enrollment in February 2021, Following Completion of Tear RASP Analysis and Finalization of Trial Design\n\n\nManagement to Host Conference Call at 8:00 a.m. ET Today\n\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced positive top-line symptom, redness, and Schirmer’s test results from the run-in cohort of the Phase 3 TRANQUILITY clinical trial in patients with dry eye disease.\n\nThe double-masked, single-center, parallel-group run-in cohort enrolled 23 patients: 12 patients were randomized to receive 0.25% reproxalap ophthalmic solution and 11 patients were randomized to receive vehicle ophthalmic solution. Patients received four doses one day prior to and two doses on the day of exposure to a 90-minute dry eye chamber with minimal humidity, high airflow, and forced visual tasking.\n\nOver all time points in aggregate in the dry eye chamber, reproxalap was observed to be statistically superior to vehicle for the two assessed symptoms, visual analog scale (VAS) ocular dryness score (p = 0.001) and ocular discomfort score (p \n“The symptom improvement observed in the run-in cohort of TRANQUILITY announced today support the first-line potential use of reproxalap in dry eye disease, and represent the first results from an ophthalmic solution for chronic use that demonstrate activity acutely following drug administration,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “The activity of reproxalap in reducing ocular redness, initially demonstrated in the allergen chamber Phase 2 clinical trial, was also observed in the dry eye chamber run-in results of TRANQUILITY, and we look forward to initiating enrollment of the main cohort.”\n\nAmong many patients and physicians, current dry eye disease therapies are considered inadequate. Discontinuation rates for lifitegrast and cyclosporine, which currently comprise standard of care, exceed 60% within 12 months of initiation of therapy, in part due to ...