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Aldeyra Therapeutics has met the primary endpoint in a Phase III clinical trial of the Reproxalap drug for dry eye disease.
Reproxalap is an investigational new drug candidate which is also being developed for the treatment of allergic conjunctivitis.
The Phase III randomised, double-masked, vehicle-controlled dry eye chamber study demonstrated that 0.25% reproxalap ophthalmic solution was statistically superior to vehicle in reducing ocular discomfort.
In the trial, 132 patients were exposed to a dry eye chamber, with half of them receiving Reproxalap and the other half a vehicle.
The primary endpoint measured ocular discomfort from 80 to 100 minutes within the chamber.
The US Food and Drug Administration (FDA) has provided feedback on the trial protocol and statistical plan, and the positive results are expected to support a potential new drug application (NDA) resubmission this year, the company said.
A first-in-class small-molecule modulator of RASP, reproxalap has shown improved results in reducing symptoms of dry eye disease and ocular redness.
The drug has been well-tolerated in trials, with over 2,500 patients studied and no significant safety concerns reported. The most common adverse event was mild and transient instillation site discomfort.
Aldeyra president and CEO Todd Brady said: “To our knowledge, the results announced today represent the first positive Phase III clinical trial in a dry eye chamber with a symptom as a primary endpoint, and we believe that the results are supportive of the potential rapid clinical effect of reproxalap on reducing the ocular discomfort associated with dry eye disease.”
"Aldeyra’s Phase III clinical trial of Reproxalap meets primary endpoint" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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