Aldeyra to File Formal Dispute Resolution Request With FDA Over Reproxalap Rejection in Dry Eye Disease

Aldeyra Therapeutics查看公司主页 plans to submit a Formal Dispute Resolution Request (FDRR) to the FDA for reproxalap查看药品详情, its investigational drug candidate for dry eye disease (搜索)搜索该疾病, appealing the March 16, 2026 Complete Response Letter (CRL) that denied approval of the company's New Drug Application. The FDA's Office of New Drugs (OND) is expected to review the request, and Aldeyra expects to submit the FDRR and meet with the OND in the fourth quarter of 2026.

The move escalates the company's regulatory effort beyond discussions with the FDA's Division of Ophthalmology, shifting the program toward formal review at a higher level within the agency.

Three Complete Response Letters

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

The third CRL, issued in March 2026, took a different position. The FDA did not request another trial but stated that the "totality of evidence from the completed clinical trials does not support the effectiveness of the product."

Across the three submission processes, Aldeyra said it provided data from nine adequate and well-controlled clinical trials, five of which met all multiplicity-controlled primary endpoints. The company says this success rate matches or exceeds that of trials for approved dry eye disease (搜索)搜索该疾病 products.

Basis for the Appeal

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 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 additional information, consult internal or external experts, or convene an advisory panel. Aldeyra said it is uncertain whether and when any of these steps will occur.

Because the latest CRL did not explicitly require another clinical trial, the immediate question before the agency is how it interprets the clinical evidence already submitted rather than whether an additional study is needed.

Company Position

Todd C. Brady, MD, PhD, president and chief executive officer of Aldeyra Therapeutics查看公司主页, said the company remains committed to working with the FDA on a novel therapeutic approach for dry eye disease (搜索)搜索该疾病, which he described as a condition often regarded by patients and physicians as inadequately addressed by available therapies.

"We remain steadfast in our commitment to working with the FDA to provide a novel therapeutic approach for the treatment of dry eye disease (搜索)搜索该疾病, a condition often regarded by patients and physicians as inadequately addressed by available therapies," Brady said. "Based on the activity of reproxalap查看药品详情 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."

That assessment reflects management's view and does not indicate how the FDA will decide the appeal.

What to Watch

Submission of the FDRR and the expected fourth-quarter meeting with the OND are the next regulatory milestones for the program. The subsequent OND response will clarify whether the existing reproxalap查看药品详情 clinical package can support another path toward approval or whether further regulatory or clinical work will be required.

Any FDA request for additional information, involvement of outside experts, or convening of an advisory panel could affect both the timing and the direction of the dispute resolution process.