Aldeyra shows dry eye treatment candidate improves symptoms

Dry eye symptoms improved in patients treated with Aldeyra Pharmaceutical’s topical ophthalmic reproxalap more than in control patients, according to data released by the company.

The phase 2b randomized, vehicle-controlled, parallel-group, double-masked clinical trial assessed safety and efficacy of reproxalap for treatment of signs and symptoms of dry eye disease.

The study included 300 patients with dry eye disease randomized equally to receive 0.1% or 0.25% reproxalap or vehicle for 12 weeks.

Patients treated with 0.25% reproxalap experienced a statistically significant and clinically relevant reduction in the four-symptom ocular dryness score (P < .05) and overall ocular discomfort symptom score (P < .05), according to a company press release.

Patients treated with reproxalap experienced greater symptom improvement across all measures when compared with patients treated with the vehicle. Patients treated with the 0.25% concentration demonstrated reduction in ocular fluorescein staining score that was statistically superior to patients treated with the vehicle.

“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,” said Todd C. Brady, MD, PhD, chief executive officer of Aldeyra. “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.”