FDA Extends Review Timeline For Aldeyra's Reproxalap NDA In Dry Eye Disease

(RTTNews) - Aldeyra Therapeutics Inc. (ALDX) announced that the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) target action date for the New Drug Application (NDA) of reproxalap, its investigational therapy for dry eye disease. The new target date is March 16, 2026.

The NDA was submitted on June 16, 2025, and accepted for review as a complete class 2 response on July 16, 2025, with an initial action date of December 16, 2025. Ahead of that deadline, the FDA met with Aldeyra on December 12, 2025, requesting the Clinical Study Report (CSR) from a field trial of reproxalap. While the trial supported activity relative to vehicle, it did not meet the primary endpoint of symptom improvement. The CSR was submitted the same day and deemed a major amendment, prompting the extension of the review timeline.

The FDA had previously requested safety data from the trial, which Aldeyra submitted in August 2025. The CSR had already been reviewed under the investigational new drug file. At the December meeting, the FDA raised no additional issues with the NDA.

Earlier in December, the FDA provided Aldeyra with a draft of the prospective product label, to which the company has responded. The agency indicated that, if no major deficiencies are identified during the extended review, it expects to communicate proposed labeling changes and any potential postmarketing requirements by February 16, 2026.

ALDX closed Monday's regular trading at $3.99, down $0.55 or 12.11%. In after-hours trading, the stock declined further to $3.32, a drop of $0.67 or 16.79%.

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