Aldeyra Therapeutics has reported positive results from its Phase llb clinical trial of topical ocular reproxalap for the treatment of patients with dry eye disease.
The trial was a randomised, vehicle-controlled, parallel-group, multi-centre, double-masked study that enrolled 300 patients.
It evaluated 0.1% and 0.25% concentrations of reproxalap topical ophthalmic solution in comparison with a vehicle in the enrolled patients who were randomised equally to receive the drug or vehicle for 12 weeks.
The trial’s primary objective was to analyse the safety and efficacy of reproxalap to treat the symptoms and signs of dry eye disease in order to select a drug concentration, confirm endpoint selection, as well as establish sample size for a pivotal Phase lll clinical programme.
Results showed that compared to the patients treated with a vehicle, the patients receiving 0.25% concentration of reproxalap experienced statistically and clinically relevant reductions in the Four-Symptom Ocular Dryness Score and the Overall Ocular Discomfort Symptom Score.
The trial also observed more improvement in symptoms than that of a vehicle.
The early onset of symptomatic improvement is also reported to be consistent with the Phase lla clinical trial of topical ocular reproxalap in dry eye disease.
In addition, patients who received the 0.25% concentration of reproxalap had reductions in ocular fluorescein staining score that were statistically better those of patients treated with vehicle.
Topical ocular reproxalap was also well tolerated and reported mild adverse events, thereby showing consistency with results from previous clinical trials.
Aldeyra Therapeutics CEO Todd Brady said: “Based on the successful Phase llb results, we look forward to initiating a Phase lll programme 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 lll clinical trials in allergic conjunctivitis and noninfectious anterior uveitis, highlights the potential of reproxalap as a highly differentiated and novel ophthalmic therapy.”
Dry eye disease is a frequently reported inflammatory disease that is estimated to affect around 20 million people in the US.