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Aldeyra Therapeutics Announces Completion of Enrollment in Phase 3 TRANQUILITY Trial in Patients with Dry Eye Disease and Reiterates New Drug Application (NDA) Submission Guidance
Top-Line Results from TRANQUILITY Expected This Quarter Together with Recently Completed Phase 2 Clinical Trial, Positive Ocular Redness Results from
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":"\n\nTop-Line Results from TRANQUILITY Expected This Quarter\n\n\nTogether with Recently Completed Phase 2 Clinical Trial, Positive Ocular Redness Results from TRANQUILITY Could Satisfy NDA Submission Requirements as Pivotal Trials for Improvement in an Objective Sign of Dry Eye Disease\n\n\nCompleted Phase 3 RENEW-Part 1 and Formulation Phase 2 Clinical Trials to be Submitted as Pivotal Trials in Satisfaction of NDA Symptom Requirements\n\n\nAnticipated NDA Submission Expected in Early 2022\n\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra or the Company), a biotechnology company developing novel immune-modulating therapies to treat ocular and systemic diseases, today announced completion of enrollment in the Phase 3 TRANQUILITY Trial of 0.25% reproxalap ophthalmic solution (reproxalap) for the treatment of patients with dry eye disease.\n\n“Following the recent announcement of top-line results from our Phase 2 clinical trial, which achieved the primary endpoint of ocular redness and which we intend to submit as a pivotal trial, completion of enrollment in TRANQUILITY is a significant milestone as we advance reproxalap toward an anticipated NDA submission early next year for the treatment of dry eye disease,” stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “If the primary endpoint of ocular redness in TRANQUILITY is achieved, and in conjunction with two previously announced clinical trials demonstrating improvement in ocular dryness symptoms, we believe that the efficacy requirements for NDA submission will have been met.”\n\nThe multi-center, double-masked, parallel-group TRANQUILITY Trial enrolled 300 patients randomized equally to receive either reproxalap or vehicle. 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. The primary endpoint of the TRANQUILITY Trial is ocular redness. Top-line results from the trial are expected this quarter.\n\n\nBased on the results of the recently completed Phase 2 clinical trial, which enrolled 158 patients and achieved statistical significance in the primary endpoint of ocular redness, TRANQUILITY is at least 90% powered to detect a statistically significant difference in ocular redness. TRANQUILITY is o...