Aldeyra Therapeutics announced the resubmission of a new drug appli-cation (NDA) to the FDA for topical ocular reproxalap, an investigational new drug candidate, for the treatment of signs and symptoms of dry eye disease (DED). According to the company, the resubmission includes previously disclosed positive results from a recently completed DED symptom trial requested by the FDA following review of the previously submitted NDA. In addition, it includes 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 2024, 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 DED. Reproxalap was statistically superior to vehicle for the prespecified primary endpoint of ocular discomfort (P=0.004), an FDA-accepted symptom of DED, the company said in a press release. 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.

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 6 months.