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Aldeyra Announces First Patient Enrolled in the Phase 3 TRANQUILITY Trial of Reproxalap for the Treatment of Dry Eye Disease
LEXINGTON, Mass.--(BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":" LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today announced enrollment of the first patient in the Phase 3 TRANQUILITY Trial of 0.25% reproxalap ophthalmic solution for the treatment of dry eye disease.\n\nThe multi-center randomized, double-masked, parallel design, vehicle-controlled clinical trial will assess the efficacy and safety of reproxalap compared to vehicle in objective sign endpoints of dry eye disease, including tear RASP (reactive aldehyde species) levels after single and multiple doses, and after exposure to a dry eye chamber; Schirmer test (tear volume) following a single dose; and conjunctival redness in the dry eye chamber over 90 minutes. A run-in cohort of 20 patients is expected to be completed this year. Results from the run-in will be used to power the main cohort of the trial, and will confirm primary and secondary endpoints.\n\n“Initiation of the Phase 3 TRANQUILITY Trial, the first trial designed to characterize the acute effects of reproxalap on RASP and other objective signs of dry eye disease, marks another important step toward a planned NDA submission in dry eye disease by the end of 2021,” said Todd C. Brady, M.D., Ph.D. “For the more than 30 million U.S. patients with dry eye disease, we believe that reproxalap has the potential to fulfill significant unmet need as a treatment with rapid onset of action and durable symptom control.”\n\nAbout Reproxalap\n\nReproxalap is a novel small-molecule immune-modulating covalent inhibitor of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease. Reproxalap’s mechanism of action has been validated with the demonstration of statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications. Reproxalap is currently in Phase 3 clinical development as a 0.25% ophthalmic solution for the treatment of dry eye disease and allergic conjunctivitis, two ocular inflammatory diseases that often occur together in the same patient.\n\nAbout Dry Eye Disease\n\nDry eye disease is a common inflammatory disease estimated to affect 34 million or more adults in the...