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# FDA Extends Review Timeline for Aldeyra’s Dry Eye Drug
- URL: https://www.fdaweb.com/fda-extends-review-timeline-for-aldeyras-dry-eye-drug/
- Published: 2025-12-16T12:00:00.000Z
- Updated: 2026-09-14T15:29:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160392

FDA has extended the review of Aldeyra Therapeutics’ NDA resubmission for reproxalap, pushing back a regulatory decision on the investigational dry eye disease treatment by three months. Aldeyra says the agency has set a new user fee review action target date of 3/16/2026 after classifying the company’s recent submission of a clinical study report as a major amendment to the application.

The June resubmission of reproxalap addressed an agency complete response letter sent in April that said the NDA “failed to demonstrate efficacy in adequate and well-controlled studies in treating ocular symptoms associated with dry eye,” according to the company. That letter requested that one additional study be conducted to demonstrate a positive effect, and the company had earlier said its resubmission included new clinical data from a recently completed dry eye chamber trial, which achieved the primary endpoint.

According to the company, during a 12/12 meeting, FDA reviewers requested that it formally submit the full clinical study report from a dry eye disease field trial whose top-line results were disclosed in May. That field trial supported reproxalap’s activity compared with vehicle, but did not meet its primary endpoint of improving dry eye symptoms relative to the control. Aldeyra said the trial and its results had been discussed with the agency before the NDA was re-filed. The agency made no additional requests and did not flag other specific review issues during the meeting, according to the company.

The clinical study report had previously been submitted to FDA under reproxalap’s IND and was reviewed in that context, Aldeyra says. Safety data from the trial were added to the NDA in August, following an earlier FDA request.

Reproxalap is being developed as a novel treatment for dry eye disease, a common inflammatory condition that affects millions of patients and has limited therapeutic options.