Aldeyra Therapeutics Inc ALDX develops therapies for treating inflammation, inborn errors of metabolism and other diseases related to endogenous aldehyde toxicity.
What Happened
The clinical-stage biotech announced a Phase 2b clinical trial that evaluated its topical ocular reproxalap in patients with dry eye disease produced positive results.
Dry eye is a condition where the eyes don't produce enough tears or when one or more of the layers of the tear film layers are affected.
The 300-patient mid-stage trial is a randomized, double-masked trial that investigated two formulations –- 0.1 percent and 0.25 percent concentration of reproxalap –- relative to vehicle over a period of 12 weeks.
The 0.25 percent concentration of reproxalap showed statistically significant and clinically relevant reductions in Four-symptom Ocular Dryness score and the Overall Ocular Discomfort Symptom score, with the improvement seen as early as two weeks, when the first assessment was made following initiation of the therapy.
The candidate differentiated it from the current standard-of-care by the early onset of symptomatic improvement, according to Aldeyra. The company added the candidate was well tolerated, with the reported adverse events being mild.
Why It's Important
The dry eye disease population, according to the company, is a common inflammatory disease estimated to affect approximately 20 million people in the United States.
The company expects to initiate a Phase 3 program in dry eye disease in 2019 following a discussion with regulatory authorities. It's also evaluating reproxalap for allergic conjunctivitis and noninfectious anterior uveitis in separate late-stage trials.
At time of publication, Aldeyra's stock as trading up more than 43 percent to $14.20.
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