Aldeyra Therapeutics Announces Positive Top-Line Data from Phase 2 Trial of Reproxalap Versus Xiidra for the Treatment of Dry Eye

Aldeyra Therapeutics Announces Positive Top-Line Data from Phase 2 Trial of Reproxalap Versus Xiidra for the Treatment of Dry Eye

Aldeyra Therapeutics announced positive top-line data from a Phase 2 clinical trial comparing reproxalap ophthalmic solution 0.25% (reproxalap) versus Novartis’ Xiidra (lifitegrast ophthalmic solution 5%), a common standard treatment in patients with dry eye disease. A statistically significant symptom improvement was reported in patients treated with reproxalap versus Xiidra. Aldeyra plans to present full data from the trial at an upcoming medical meeting.

The double-masked, crossover, single-center trial enrolled 56 dry eye disease patients. The trial 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.

Patient-reported ocular discomfort and itching were statistically lower with reproxalap than with X...

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