Aldeyra Therapeutics, Inc. (ALDX) has announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational drug aimed at treating the signs and symptoms of dry eye disease (DED). This action follows a Complete Response Letter (CRL) from the FDA in November 2023, which requested additional evidence of efficacy in treating ocular symptoms associated with dry eyes.
The resubmitted NDA includes positive results from a Phase 3 randomized, double-masked, vehicle-controlled dry eye chamber clinical trial. In this trial, reproxalap demonstrated statistical superiority over the vehicle for the primary endpoint of ocular discomfort (P=0.004), a symptom recognized by the FDA as relevant to DED. The resubmission also features a draft label that reflects acute activity in reducing dry eye symptoms in a dry eye chamber trial, chronic activity in reducing dry eye symptoms in a field trial, and acute activity in reducing ocular redness in two dry eye chamber trials.
Clinical Trial Details and Results
The Phase 3 trial involved 132 randomized patients, with 66 receiving reproxalap and 66 receiving the vehicle. Ocular discomfort was measured between 80 to 100 minutes within the dry eye chamber. Aldeyra believes these results support the potential for a rapid clinical effect of reproxalap in alleviating ocular discomfort associated with DED.
Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra, stated, "If approved, reproxalap would have the potential to be the first DED therapy for chronic use with pivotal data demonstrating acute activity in reducing dry eye symptoms and ocular redness, two characteristics of dry eye disease of primary importance to patients."
About Reproxalap
Reproxalap is a first-in-class small-molecule modulator of reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory diseases. It is also in development for allergic conjunctivitis. Clinical trials have studied reproxalap in over 2,500 patients, with mild and transient instillation site irritation being the most commonly reported adverse event.
Regulatory Timeline
Under the Prescription Drug User Fee Act (PDUFA), the FDA is expected to acknowledge acceptance of the resubmitted NDA for review within 30 days, with a completion of the review anticipated within 6 months.
