Results from Adaptive Phase 3 RENEW Trial of Reproxalap for Dry Eye Disease
Aldeyra Therapeutics, Inc. announced positive top-line results from Part 1 of the adaptive Phase 3 RENEW Trial of topical ocular reproxalap in patients with dry eye disease.
The 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. Part 1’s primary objective was to confirm dosing regimen, endpoints, and sample size for Part 2. It included 422 patients who were randomized to receive either reproxalap or vehicle four times daily for 12 weeks (constant dosing group) or reproxalap or vehicle four times daily for 4 weeks, followed by twice-daily reproxalap or vehicle for 8 weeks (induction-maintenance dosing group).
Observed activity versus vehicle in the induction-maintenance group was greater than that in the constant dosing group. The induction-maintenance dosing regimen is advancing to Part 2.
Results showed that the primary objective was achieved. The co-primary endpoint of patient-reported visual analog scale (VAS) ocular dryness from Weeks 2 to 12 was achieved (p = .0004) in the induction-maintenance dosing group; activity was observed as early as 1 week after starting therapy (p = .001) and maintained until the end of the trial. In this same group, reproxalap was statistically better than vehicle in VAS ocular endpoints for itching (p = .03), foreign body sensation (p = .004), discomfort (p = .003), photophobia (p = .004), and pain (p = .03). It was also statistically better than vehicle in Ocular Discomfort & 4-Symptom Questionnaire ocular endpoints for dryness (p = .01), discomfort (p = .03), burning (p = .03), grittiness (p = .003), and stinging (p = .02). From Weeks 1 to 4, reproxalap was statistically better than vehicle in reduction from baseline (p = .03).
These initial results suggest reproxalap may be used to treat a range of dry eye disease states, especially as it is one of the first drugs to reduce ocular itching.
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