Aldeyra to appeal FDA rejection of reproxalap as a treatment for dry eye disease

Aldeyra Therapeutics, Inc. plans to submit a Formal Dispute Resolution Request (FDRR) to the FDA for reproxalap, its investigational drug candidate for dry eye disease. The request appeals the March 16, 2026 Complete Response Letter (CRL) that denied approval of the company's New Drug Application (NDA). The FDA's Office of New Drugs (OND) is expected to review it. It expects to submit the FDRR and meet with the OND in the fourth quarter of 2026.¹

Regulatory history

Aldeyra submitted the NDA once and resubmitted it twice. Each submission ended in a CRL: Regarding the first and second CRLs, the FDA recommended an additional clinical trial to "demonstrate a positive effect on the treatment of ocular symptoms of dry eye."

After the third CRL was submitted in March 2026), the FDA did not ask for more trials. It stated that the "totality of evidence from the completed clinical trials does not support the effectiveness of the product."

Throughout the three submission processes, the company provided data from what the company described as nine adequate and well-controlled clinical trials, of which five met all multiplicity-controlled primary endpoints. The company says this success rate matches or exceeds that of trials for approved dry eye disease products.

Basis for the appeal and timeline

Aldeyra filed the FDRR after recent Type A and Type D meetings with the FDA Division of Ophthalmology and the Office of Specialty Medicine. Under the Prescription Drug User Fee Act target timelines for the FDRR process, the company expects to meet with the OND in the fourth quarter of 2026.

The timing of the OND's decision depends on several factors: the deciding official may request more information, consult internal or external experts, or convene an advisory panel. It is uncertain whether and when any of these will happen.

Company perspective

Todd C. Brady, MD, PhD, president and chief executive officer of Aldeyra Therapeutics, emphasized, "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. Based on the activity of reproxalap across a number of clinical trial designs, and against a backdrop of FDA dry eye disease product approvals that have applied considerable discretion, we are optimistic in the outcome of the FDRR."

Reference

1. Aldeyra Therapeutics announces intent to submit Formal Dispute Resolution Request for reproxalap to treat dry eye disease. News release. Aldeyra Therapeutics. September 29, 2026. Accessed September 29, 2026. https://ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-announces-intent-submit-formal-dispute