Aldeyra Resubmits NDA for Topical Ocular Reproxalap for Dry Eye Disease

Aldeyra Therapeutics announced the resubmission of a new drug application (NDA) to the FDA for its investigational topical drug, reproxalap, which is intended to treat the signs and symptoms of dry eye disease.

The resubmission follows a recent FDA-requested trial that demonstrated positive results in reducing symptoms of dry eye disease, according to Aldeyra. The updated NDA also includes a draft label outlining reproxalap’s ability to reduce dry eye symptoms both acutely and chronically. In clinical trials, the drug demonstrated acute activity in reducing ocular discomfort and redness during dry eye chamber tests, and chronic benefits during field trials.

“If approved, reproxalap would potentially become the first chronic-use therapy for dry eye disease, backed by pivotal data showing its effectiveness in rapidly reducing both ocular discomfort and redness—two symptoms of critical importance to patients,” Todd C. Brady, MD, PhD, President and CEO of Aldeyra Therapeutics, said in a company news release. 

In November 2023, the FDA issued a complete response letter to Aldeyra's new drug application (NDA) submission for reproxalap. No safety or manufacturing issues with reproxalap were identified, however, the FDA letter stated that the NDA did not demonstrate “efficacy in treating ocular symptoms associated with dry eyes” and that “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye” should be conducted.

In August 2024, Aldeyra reported that its phase 3 clinical trial of reproxalap met the primary endpoint in a randomized, double-masked, vehicle-controlled dry eye chamber study. Reproxalap was statistically superior to the vehicle in reducing ocular discomfort, a key symptom of dry eye disease, with a P-value of 0.004, supporting the drug's potential for rapid clinical benefit. According to the company, this marks the first positive phase 3 trial in a dry eye chamber study that used symptom reduction as the primary endpoint.

Under the Prescription Drug User Fee Act (PDUFA), the FDA is expected to acknowledge receipt of the resubmitted NDA within 30 days, with a review expected to be completed within 6 months.