Aldeyra Therapeutics Announces Positive Top-Line Results from 12-Month Safety Clinical Trial of Reproxalap in Patients with Dry Eye Disease

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced top-line results from a 12-month, vehicle-controlled, multicenter, parallel-group safety clinical trial of reproxalap, an investigational new drug, in dry eye disease patients. The primary endpoints of treatment-related serious adverse events in ocular safety were not observed in any patient. Ocular safety events were similar across reproxalap and vehicle treatment groups. In a post-hoc analysis, reproxalap was statistically superior to vehicle in improvement from baseline in distance visual acuity, potentially representing the first demonstration of improvement in distance visual acuity with a topically administered therapy.

“The lack of treatment-related serious adverse events over 12 months confirms the safety profile of reproxalap observed in prior clinical trials, and the potentially landmark evidence of improvement in visual acuity may differentiate reproxalap, if approved for sale, from other therapeutic options for the treatment of dry eye disease,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra.

The 12-month safety clinical trial population was comprised of 447 dry eye disease patients; 299 patients were treated with reproxalap and 148 patients were treated with vehicle. Visual acuity and ocular safety assessments, including assessment of intraocular pressure, slit-lamp examination, corneal endothelial cell density, and dilated fundoscopy, were performed at baseline, and after 4 weeks, 6 weeks, 3 months, 6 months, and one year of treatment. The primary endpoints were the proportion of treatment-related ocular safety events related to visual acuity, intraocular pressure, slit-lamp examination, and dilated fundoscopy in reproxalap-treated patients compared to vehicle-treated patients. Change from baseline in visual acuity, as assessed by the logarithm of the minimum angle of resolution (logMAR, lower values indicate better visual acuity), was analyzed post-hoc over 12 months using a repeated measures analysis.

No serious adverse events related to treatment were observed in any patient. Ocular safety parameters were similar between treatment groups. Consistent with prior experience with reproxalap and other topical ocular medications, the most common adverse event in reproxalap-treated patients was mild and transient instillation site irritation.

Visual acuity improved over 12 months in both treatment groups, and improvement in patients treated with reproxalap was statistically superior (P=0.018) to that in patients treated with vehicle. In the reproxalap treatment group, logMAR improved by approximately 37% (P<0.0001), from 0.13 (Snellen 20/27) to 0.08 (Snellen 20/24).