Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) shares rose Wednesday after reporting positive results from Phase 2b dry eye disease clinical trial. The study showed statistically significant improvement across multiple symptom and sign measures.
The Lexington, Mass.-based Aldeyr is a biotechnology company devoted to development of next-generation medicines to improve the lives of patients with immune-mediated diseases.
The randomized, vehicle-controlled, parallel-group, multi-center, double-masked Phase 2b clinical trial investigated 0.1% and 0.25% concentrations of reproxalap topical ophthalmic solution versus vehicle.
Relative to patients treated with vehicle, patients treated with the 0.25% concentration of reproxalap had statistically significant and clinically relevant reductions in the Four-Symptom Ocular Dryness Score (p<0.05) and the Overall Ocular Discomfort Symptom Score (p<0.05).
Symptom improvement greater than that of vehicle was consistently observed across all measures, and activity versus vehicle was demonstrated as early as two weeks
In all, 300 patients with dry eye disease were randomized equally to receive 0.1%, 0.25%, or vehicle for 12 weeks.
According to CEO Todd Brady "Based on the successful Phase 2b results, we look forward to initiating a Phase 3 program in dry eye disease in 2019 following our discussion with regulatory authorities.
"The addition of dry eye disease to our late-stage clinical portfolio, which includes Phase 3 clinical trials in allergic conjunctivitis and noninfectious anterior uveitis, highlights the potential of reproxalap as a highly differentiated and novel ophthalmic therapy."
Shares leaped $2.29, or 23.1%, to $12.19, establishing a fresh new 52-week high.
