PDUFA Date Extended for Aldeyra’s Reproxalap Dry Eye NDA
Aldeyra Therapeutics a biotechnology company focused on the discovery and development of innovative therapies for immune-mediated and inflammatory diseases, has announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the New Drug Application (NDA) of reproxalap for the treatment of dry eye disease. The revised PDUFA target action date is now set for March 16, 2026.
The extension follows a regulatory request from the FDA during the ongoing review process. Aldeyra originally submitted the NDA for reproxalap on June 16, 2025. The application was subsequently accepted for review by the FDA as a complete Class 2 resubmission on July 16, 2025, at which time the agency established an initial PDUFA target action date of December 16, 2025. The acceptance of the NDA marked a key milestone for Aldeyra as it advanced reproxalap toward potential regulatory approval for dry eye disease, a chronic and multifactorial condition affecting millions of patients worldwide.
On December 12, 2025, Aldeyra met with the FDA to discuss the ongoing NDA review. During this meeting, the FDA requested that Aldeyra submit the Clinical Study Report (CSR) for the dry eye disease field trial of reproxalap. The top-line results from this field trial had previously been disclosed by the company on May 5, 2025. Although the field trial demonstrated activity of reproxalap relative to vehicle, it did not meet its primary endpoint of statistically significant improvement in dry eye symptoms compared with the vehicle control.
Importantly, Aldeyra noted that the field trial and its results had been discussed with the FDA prior to the original NDA submission in June 2025. The CSR for the field trial had also been previously submitted to the Investigational New Drug (IND) application for reproxalap and had already undergone FDA review in that context. Following the December 12 meeting, Aldeyra submitted the CSR to the NDA on the same day. The FDA classified this submission as a major amendment to the NDA, which under regulatory guidelines resulted in a three-month extension of the PDUFA review timeline.
Aside from the request for the CSR, the FDA did not raise any additional questions or identify any other specific issues related to the NDA review during the December 12 meeting. Aldeyra also confirmed that, in accordance with an earlier FDA request, safety data from the dry eye disease field trial had been submitted to the NDA on August 21, 2025. This submission further supported the agency’s ongoing evaluation of reproxalap’s safety profile.
In early December 2025, the FDA shared a draft version of the proposed product label for reproxalap with Aldeyra. The company has since submitted its response to the draft labeling. According to Aldeyra, the FDA has indicated that if no major deficiencies are identified during the extended review period, the agency plans to communicate proposed labeling requests and any anticipated postmarketing requirements, if applicable, by February 16, 2026. This step would represent another important milestone in the regulatory process and could help clarify the path toward a potential approval decision.
Dry eye disease is a common and often chronic ocular condition characterized by tear film instability, ocular surface inflammation, and symptoms such as dryness, irritation, burning, and visual disturbance. Despite the availability of several approved therapies, many patients continue to experience inadequate symptom relief, underscoring the need for new treatment options. Reproxalap is a novel small-molecule reactive aldehyde species (RASP) inhibitor designed to address inflammatory pathways implicated in dry eye disease and other immune-mediated conditions.
Aldeyra has positioned reproxalap as a differentiated therapeutic candidate based on its proposed mechanism of action and clinical development program. The company believes that reproxalap has the potential to offer meaningful benefits to patients with dry eye disease, particularly those who do not respond adequately to existing treatments. While the outcome of the NDA review remains uncertain, Aldeyra continues to engage constructively with the FDA to address regulatory requirements and advance the application toward a final decision.
To provide additional context and discuss the implications of the PDUFA extension, Aldeyra announced that it will host a conference call at 8:00 a.m. Eastern Time on Tuesday, December 16, 2025. The call will include a discussion of the FDA’s request, the revised review timeline, and next steps in the regulatory process. Domestic callers may dial (833) 470-1428, while international callers may dial (646) 844-6383. The access code for the call is 438712. A live webcast of the conference call will also be available through the Investor Relations section of Aldeyra’s website.
This announcement contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding Aldeyra’s expectations, plans, and prospects, including anticipated timing of regulatory action; the potential outcome of the NDA for reproxalap for the treatment of dry eye disease; the possible labeling of reproxalap if approved; and the goals, opportunities, and commercial potential associated with reproxalap.
Forward-looking statements are subject to risks, uncertainties, and assumptions that could cause actual results to differ materially from those expressed or implied in such statements. In many cases, forward-looking statements can be identified by the use of words such as “may,” “might,” “will,” “should,” “could,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “plan,” “estimate,” “predict,” “potential,” “continue,” or similar expressions, as well as their negatives.
Aldeyra cautions that it is still at an early stage of development and may not ultimately succeed in developing or commercializing any product candidates that generate significant revenue. Development timelines may change based on a variety of factors, including regulatory review, clinical trial results, funding availability, and operational considerations. Regulatory approval is not guaranteed, and the FDA may require additional data, analyses, or clinical studies before approving reproxalap or any other Aldeyra product candidate.
Additional risks include the possibility that results observed in preclinical or clinical studies may not be replicated or sustained in future trials; delays in enrollment, completion, or analysis of clinical studies; challenges associated with manufacturing, commercialization, and reimbursement; competitive pressures; the company’s ability to attract and retain key personnel; and broader economic, political, legal, and public health factors that could impact Aldeyra’s business or the global healthcare environment.
Further information about these and other risks is included in Aldeyra’s filings with the U.S. Securities and Exchange Commission (SEC), including the company’s Annual Report on Form 10-K for the year ended December 31, 2024, and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2025. These documents are available on the SEC’s website and provide a more comprehensive discussion of the factors that could affect Aldeyra’s future performance.
The information contained in this release is provided as of the date of publication, and Aldeyra undertakes no obligation to update or revise any forward-looking statements as a result of new information, future events, or otherwise, except as required by law
About Aldeyra
Aldeyra Therapeutics is a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated diseases. Our approach is to develop pharmaceuticals that modulate protein systems, instead of directly inhibiting or activating single protein targets, with the goal of optimizing multiple pathways at once while minimizing toxicity. Our product candidates include RASP (reactive aldehyde species) modulators ADX-248, ADX-246, and chemically related molecules for the potential treatment of systemic and retinal immune-mediated diseases. Our late-stage product candidates are reproxalap, a RASP modulator for the potential treatment of dry eye disease and allergic conjunctivitis, and ADX-2191, a novel formulation of intravitreal methotrexate for the potential treatment of primary vitreoretinal lymphoma and retinitis pigmentosa.
