Aldeyra Therapeutics (NASDAQ:ALDX) said the U.S. Food and Drug Administration has extended the PDUFA target action date for its reproxalap New Drug Application (NDA) for dry eye disease to March 16, 2026, adding roughly three months to the original timeline.
The NDA, submitted on June 16, 2025, had been accepted as a complete Class 2 response with an initial action date of December 16, 2025.
But following a December 12 meeting, the FDA asked Aldeyra to formally submit the Clinical Study Report (CSR) from a reproxalap dry eye field trial as part of the NDA.
The field trial, whose top-line results were released in May, demonstrated activity for reproxalap relative to vehicle but did not meet its primary symptom endpoint.
Aldeyra had previously discussed the trial with the agency ahead of the NDA filing.
The CSR had already been reviewed under the therapy’s IND, but its addition to the NDA was deemed a major amendment, triggering the PDUFA extension.
Aldeyra submitted the requested safety data from the field trial on August 21, 2025, per a prior FDA request.
At the December meeting, the FDA raised no other concerns or deficiencies with the ongoing review.
The agency had earlier provided Aldeyra with a draft label, to which the company has responded.
The FDA said that—barring the emergence of major issues during the extended review—it expects to communicate proposed labeling revisions and any postmarketing requirements no later than February 16, 2026.
The decision delay marks a regulatory setback but keeps the pathway open for reproxalap, as dry eye disease remains a large and competitive market with few recently approved mechanisms.