Concord, Mass. — Aldeyra Therapeutics announced plans to submit a Formal Dispute Resolution Request to the U.S. Food and Drug Administration seeking review of the agency’s decision not to approve reproxalap for the treatment of dry eye disease.
The company said the request will appeal a March 16, 2026 Complete Response Letter denying approval of its New Drug Application for reproxalap. Aldeyra expects to submit the request and meet with the FDA’s Office of New Drugs in the fourth quarter of 2026.
Reproxalap is an investigational drug candidate being developed for dry eye disease.
Aldeyra has submitted one NDA and two resubmissions for reproxalap and has received three Complete Response Letters from the FDA.
The company said the first two letters recommended an additional clinical trial to demonstrate an effect on ocular symptoms of dry eye disease. The most recent letter did not request another clinical trial but stated that the totality of evidence from completed studies did not support the effectiveness of the product.
Aldeyra said it has submitted data from nine adequate and well-controlled clinical trials, five of which met all multiplicity-controlled primary endpoints.
The decision to pursue the formal dispute process follows Type A and Type D meetings with the FDA’s Division of Ophthalmology and Office of Specialty Medicine.
The timing of an FDA decision on the dispute will depend on whether the agency requests additional information, consults internal or external experts, or convenes an advisory panel.
“We remain steadfast in our commitment to working with the FDA to provide a novel therapeutic approach for the treatment of dry eye disease, a condition often regarded by patients and physicians as inadequately addressed by available therapies,” said Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra Therapeutics.
Brady said the company remains optimistic about the outcome of the dispute resolution process based on clinical trial results for reproxalap and prior FDA decisions involving dry eye disease therapies.
Aldeyra also said that, based on cash and cash equivalents of $45.1 million as of June 30, 2026, it now expects its operational cash runway to extend into 2029.
