FDA Extends Review of Reproxalap for Dry Eye Disease to March 16 Amid Clinical Study Requests

The U.S. Food and Drug Administration extended its review of Aldeyra Therapeutics’ new drug application for reproxalap to March 16, 2026, the company announced following a December 12 meeting. The delay was prompted by the FDA’s request for a Clinical Study Report from a dry eye disease field trial, which was classified as a major amendment requiring additional review time, officials said.

The extension follows a December 12 meeting between Aldeyra Therapeutics and the FDA, during which the agency requested a Clinical Study Report (CSR) from a dry eye disease field trial, officials said.

The FDA classified the CSR submission as a major amendment, triggering additional review time that postponed the Prescription Drug User Fee Act (PDUFA) target action date from December 16, 2025, to March 16, 2026, according to company statements and FDA records.

Aldeyra Therapeutics submitted the new drug application (NDA) for reproxalap on June 16, 2025, with the FDA accepting it for review as a “complete class 2 response” on July 16, 2025, sources confirmed. This submission followed a prior resubmission in October 2024 and came after the agency issued a second Complete Response Letter (CRL) in April 2025, which raised questions addressed in the current filing, according to regulatory documents.

The requested CSR pertains to a dry eye disease field trial whose topline results were announced by Aldeyra on May 5, 2025. Safety data from this trial were submitted to the FDA on August 21, 2025, in response to agency requests, according to company disclosures. The FDA has reviewed the CSR under an Investigational New Drug (IND) application, officials said, and the new data supported the NDA resubmission process.

The December 12 meeting occurred within the original PDUFA review period, which was set to expire on December 16, 2025. Following the FDA’s request and Aldeyra’s CSR submission, the agency extended the review period to accommodate the major amendment, according to Aldeyra’s announcement and FDA communications. No further details about the meeting’s discussions or additional requirements were disclosed.

Reproxalap is a first-in-class investigational treatment targeting dry eye disease through a novel mechanism, according to Aldeyra Therapeutics. The NDA focuses on a prescription eye drop formulation intended to address symptoms associated with the condition. The drug has undergone multiple regulatory interactions, including three Complete Response Letters, reflecting the agency’s ongoing evaluation process, records show.

The regulatory timeline for reproxalap includes the initial NDA acceptance on July 16, 2025, followed by the submission of safety data on August 21, 2025, and topline trial results in early May 2025. The April 2025 CRL marked a significant milestone leading to the June 2025 NDA resubmission. The recent FDA extension moves the PDUFA date to March 16, 2026, according to Aldeyra Therapeutics.

Aldeyra has complied with FDA requests throughout the review process, including the submission of the CSR classified as a major amendment. The company has not announced any additional amendments or changes beyond the CSR submission, officials said. The FDA’s ongoing review under the IND application continues as the agency evaluates the safety and efficacy data supporting reproxalap’s potential approval.