First patient enrolled in the RENEW phase III clinical trialof reproxalap for dry eye disease

Aldeyra Therapeutics, Inc.announced enrollment of the first patient into the RENEW Phase III clinical trial of topical ocular reproxalap for the treatment of dry eye disease . The RENEW Trial is a two-part, multi-center, randomized, double-masked, parallel-group, vehicle-controlled, adaptive Phase III clinical trial evaluating the efficacy of reproxalap ophthalmic solution (0.25%) vs. vehicle in 400 patients with moderate-to-severe dry eye disease. Results from the first part of the trial will confirm the dosing regimen and sample size for the second part. The co-primary endpoints of the trial will be ocular dryness and fluorescein nasal region ocular staining in pre-specified moderate to severe patient subsets analyzed over twelve weeks of therapy using Mixed effects Model Repeated Measures (MMRM).

In September 2018, Aldeyra reported results from a Phase IIb dry eye disease clinical trial, which demonstrated statistical superiority of reproxalap versus vehicle across multiple symptoms and signs. In the Phase IIb clinical trial, the MMRM p values for the Phase III co-primary endpoints of dryness and staining were 0.0048 and 0.0007, respectively.