Aldeyra Therapeutics announced it has completed enrolment for its new phase 3 clinical trial of topical ocular 0.25% reproxalap, an investigational RASP modulator for the treatment of dry eye disease. The trial is designed to allow the company to reapply for a new drug application in late 2024 after the US FDA requested additional data to demonstrate efficacy in late 2023.
The new trial includes 132 patients who will be randomised to receive either the drug or control vehicle before and during exposure to a dry eye chamber, with the primary endpoint being ocular discomfort, said the company. “The planned dry eye chamber clinical trial, if successful, could represent the first pivotal demonstration of rapid improvement in the symptoms of dry eye disease,” said Dr Todd Brady, Aldeyra president and CEO.
