Aldeyra Seeks FDA Dispute Resolution After 3 Complete Responses

Aldeyra Therapeutics says it intends to submit a Formal Dispute Resolution Request to FDA, challenging a 3/16 Complete Response Letter that denied approval of the company’s NDA for reproxalap for treating dry eye disease.

“Following an NDA submission and two NDA resubmissions of reproxalap for the treatment of dry eye disease, Aldeyra has received three Complete Response Letters, the first two of which recommended an additional clinical trial to ‘demonstrate a positive effect on the treatment of ocular symptoms of dry eye’ and the most recent of which did not request further clinical trials but stated that the ‘totality of evidence from the completed clinical trials does not support the effectiveness of the product,’” the company says. “Over the course of the three NDA submissions, Aldeyra has provided data from nine adequate and well-controlled clinical trials, five of which achieved all multiplicity-controlled primary endpoints, consistent with or greater than the success rates of clinical trials conducted for approved dry eye disease products.”

The decision to submit the FDA dispute review was based on the outcome of recent Type A and Type D meetings with CDER’s Division of Ophthalmology and the Office of Specialty Medicine, according to the company. Aldeyra expects to hold a meeting with the Office of New Drugs before the end of the year.