Aldeyra Therapeutics, Inc. announced positive top-line data from a Phase 2 clinical trial comparing ocular discomfort and itching symptom scores of reproxalap ophthalmic solution 0.25% (reproxalap), an investigational new drug, versus Xiidra® (lifitegrast ophthalmic solution 5%) in patients with dry eye disease. Patient-reported ocular discomfort (p=0.002) and itching (p=0.01) were statistically lower with reproxalap than with Xiidra. The double-masked, crossover, single-center, Phase 2 clinical trial in 56 dry eye disease patients evaluated the activity of reproxalap compared to Xiidra for two endpoints: ocular discomfort symptom score and ocular itching symptom score.

A single dose of test article was administered to both eyes approximately 5 minutes prior to a dry eye chamber exposure lasting 45 minutes, during which humidity was maintained at low levels in a setting of regulated air flow, temperature, and visual tasking. Symptoms were assessed approximately 15 minutes prior to chamber entry, and every 5 minutes beginning 5 minutes after chamber entry. No safety signals were observed in the trial, and there were no treatment-related discontinuations or moderate or serious adverse events related to drug.

The most common adverse event in both treatment arms was mild instillation site discomfort. Reproxalap has now been evaluated in more than 1,500 patients. The approved commercial dosing regimen of Xiidra and the intended commercial dosing regimen of reproxalap include repeated administration of drug.