Aldeyra resubmits topical ocular reproxalap NDA to FDA

Aldeyra announced the resubmission of a new drug application, or NDA, to the FDA for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease. The resubmission includes previously disclosed positive results from a recently completed dry eye disease symptom trial requested by the FDA following review of the previously submitted NDA, as well as a draft label reflecting 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. In August, Aldeyra announced the achievement of the primary endpoint in a Phase 3 randomized, double-masked, vehicle-controlled dry eye chamber clinical trial of reproxalap in patients with dry eye disease. Reproxalap was statistically superior to vehicle for the prespecified primary endpoint of ocular discomfort, an FDA-accepted symptom of dry eye disease. To Aldeyra’s knowledge, the results represented the first positive Phase 3 clinical trial in a dry eye chamber with a symptom as a primary endpoint, and Aldeyra believes that results are supportive of the potential rapid clinical effect of reproxalap on reducing the ocular discomfort associated with dry eye disease. The Prescription Drug User Fee Act target guidelines for NDA resubmissions include acknowledgment of acceptance for review within 30 days of submission, and completion of submission review within six months.