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Aldeyra Therapeutics Announces Completion of Enrollment in Phase 3 TRANQUILITY-2 Trial in Patients with Dry Eye Disease
Top-Line Results from TRANQUILITY-2 Expected in the Second Quarter of 2022 LEXINGTON, Mass.--(BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX)
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":"\nTop-Line Results from TRANQUILITY-2 Expected in the Second Quarter of 2022\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company discovering and developing innovative therapies for the treatment of immune-mediated diseases, today announced completion of enrollment in the Phase 3 TRANQUILITY-2 Trial of 0.25% reproxalap ophthalmic solution (reproxalap) in patients with dry eye disease.\n\nThe multi-center, double-masked, parallel-group TRANQUILITY-2 Trial enrolled 361 patients randomized to receive either reproxalap or vehicle over two days. On the first day, patients received four doses, and Schirmer testing (a measure of tear volume) was performed before and after the fourth dose. On the second day, doses were administered just prior to and at the mid-point of a 90-minute dry eye chamber with minimal humidity, high airflow, and forced visual tasking. The primary endpoints of the TRANQUILITY-2 Trial are Schirmer test on the first day of dosing and ocular redness on the second day of dosing during the dry eye chamber. Top-line results from the trial are expected to be announced this quarter.\n\nBased on the results of the previously completed Phase 2 and TRANQUILITY clinical trials, TRANQUILITY-2 is at least 90% powered to detect a statistically significant difference in Schirmer test or ocular redness endpoints. If successful in meeting one of the primary endpoints, TRANQUILITY-2 could complete New Drug Application (NDA) submission requirements for demonstration of improvement in an objective sign of dry eye disease.\n\nPer draft U.S. Food and Drug Administration (FDA) guidance, to be considered for regulatory approval in the United States, a product candidate for the treatment of dry eye disease must demonstrate efficacy in an objective sign in at least two clinical trials and efficacy in a subjective symptom in at least two clinical trials. To satisfy the symptom efficacy requirements, Aldeyra intends to submit two previously completed 12-week adequate and well-controlled symptom trials that pre-specified patient-reported ocular dryness score as a primary endpoint, the Phase 3 RENEW-Part 1 Trial and the Formulation Phase 2 clinical trial.\n\nAldeyra’s previously announced Phase 2 clinical trial achieved the primary endpoint of ocular redness, an approvable sign o...