Aldeyra Therapeutics Announces Positive Results from Dry Eye Disease Clinical Trial

Aldeyra Therapeutics announced positive results from its Phase 2b clinical trial of topical ocular reproxalap in patients with dry eye disease.

"The early onset and broad activity observed in the Phase 2b clinical trial suggests that reproxalap could be an important treatment option relative to existing therapies," said John Sheppard, M.D., Professor of Ophthalmology, Eastern Virginia Medical School. "The results announced today confirm the potential of reproxalap, a drug with a novel mechanism of action, as a promising and differentiated therapeutic agent for dry eye disease, which remains a persistently challenging condition for large numbers of patients worldwide."

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 (the first assessment following initiation of therapy). The early onset of symptomatic improvement is consistent with the Phase 2a clinical trial of topical ocular reproxalap in dry eye disease, and is supportive of a differentiated product profile relative to current standard of care. Patients treated with the 0.25% concentration of reproxalap also demonstrated reductions in ocular fluorescein staining score that were statistically superior to those of patients treated with vehicle (p<0.05).

Both 0.1% and 0.25% reproxalap concentrations demonstrated activity relative to vehicle, and a clear dose response was observed. Consistent with previous clinical trials, topical ocular reproxalap was well tolerated, and reported adverse events were generally mild.

Three hundred patients with dry eye disease were randomized equally to receive 0.1%, 0.25%, or vehicle for 12 weeks. The primary objective of the trial was to evaluate the safety and efficacy of reproxalap for the treatment of the symptoms and signs of dry eye disease in order to select a drug concentration, confirm endpoint selection, and determine sample size for a pivotal Phase 3 clinical program.

"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, M.D., Ph.D., 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."

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