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Aldeyra Therapeutics Announces Positive Top-Line Results from Part 1 of Adaptive Phase 3 RENEW Trial in Dry Eye Disease
Primary objective of RENEW Part 1 achieved: Induction-maintenance dosing regimen of topical ocular reproxalap advanced to RENEW Part 2 Reproxalap
About this update from Aldeyra Therapeutics, Inc.
[{"type":"text","content":"\n\nPrimary objective of RENEW Part 1 achieved: Induction-maintenance dosing regimen of topical ocular reproxalap advanced to RENEW Part 2\n\n\nReproxalap statistically superior to vehicle in RENEW co-primary endpoint of ocular dryness score in induction-maintenance regimen - symptomatic improvement observed as early as one week after initiation of therapy and at all measured timepoints \n\n\nRelative to vehicle, induction-maintenance dosing regimen demonstrated broad and statistically significant activity across majority of assessed symptoms\n\n\nRENEW Part 2 expected to initiate in the first half of 2020\n\n\nConference call to be held at 8:00 AM Eastern Standard Time today\n\n\n LEXINGTON, Mass.--(BUSINESS WIRE)--\nAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases, announced today positive top-line results from Part 1 of the adaptive Phase 3 RENEW Trial of topical ocular reproxalap in patients with dry eye disease.\n\n\n“To our knowledge, reproxalap is the first topical dry eye disease drug to demonstrate statistically significant ocular dryness symptom improvement relative to vehicle as soon as one week after initiation of treatment, and thus has the potential to be first-line therapy,” commented Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “The breadth of symptomatic activity highlighted by the induction-maintenance dosing regimen results in RENEW Part 1 demonstrate the potential of reproxalap in treating dry eye disease, one of the largest - yet least-served - markets in ophthalmology.”\n\n\nThe RENEW Trial is an ongoing adaptive, two-part, multi-center, randomized, vehicle-controlled, double-masked, parallel-group Phase 3 trial of 0.25% topical ocular reproxalap compared to vehicle in patients with moderate to severe dry eye disease. The primary objective of RENEW Part 1 was to confirm dosing regimen, endpoints, and sample size for RENEW Part 2. In Part 1 of RENEW, 422 patients were randomized equally to receive either four-times-daily reproxalap or vehicle for twelve weeks (the constant dosing group) or four-times-daily reproxalap or vehicle for four weeks, followed by twice-daily reproxalap or vehicle for eight weeks (the induction-...