Aldeyra Therapeutics Faces FDA PDUFA Date Extension for Dry Eye Disease Candidate
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) has received an extension from the U.S. Food and Drug Administration (FDA) for the Prescription Drug User Fee Act (PDUFA) target action date for its New Drug Application (NDA) for reproxalap, a potential treatment for dry eye disease. The new target date is now March 16, 2026, pushing back the original December 16, 2025 deadline.
The submission of the NDA on June 16, 2025, was initially accepted by the FDA on July 16, 2025, as a “complete class 2 response.” However, on December 12, 2025, the FDA requested the submission of the Clinical Study Report (CSR) for the dry eye disease field trial of reproxalap. This trial, while supportive of reproxalap’s activity compared to a vehicle, did not achieve its primary endpoint of improving dry eye symptoms over the vehicle control. Notably, this field trial was discussed with the FDA prior to the NDA submission in June.
During the December 12 meeting, the FDA did not raise any other issues or requests concerning the NDA review. The CSR, previously part of the Investigational New Drug (IND) filing for reproxalap, was submitted to the NDA on the same day as the meeting and was classified by the FDA as a major amendment. Safety data from the field trial had already been submitted to the NDA on August 21, 2025, as per the FDA’s earlier request. The CSR itself had been reviewed by the FDA under the IND.
In early December, Aldeyra received a draft of the prospective drug label from the FDA and has since submitted a response. The agency has indicated that if no significant deficiencies are identified during this extended review period, it plans to communicate proposed labeling requests and any potential postmarketing requirements by February 16, 2026.
The extension of the PDUFA date signifies a common, albeit sometimes frustrating, part of the drug development process. For Aldeyra, this delay means a longer wait to potentially bring a new therapeutic option to market for the millions suffering from dry eye disease. The company’s strategy of modulating protein systems, rather than directly targeting single proteins, aims to optimize multiple pathways simultaneously while mitigating toxicity. This approach is central to their pipeline, which includes other RASP (reactive aldehyde species) modulators.
The dry eye disease market is substantial, driven by factors such as aging populations, increased screen time, and environmental irritants. The success of reproxalap hinges not only on FDA approval but also on its clinical efficacy, safety profile, and its ability to differentiate itself from existing treatments in a competitive landscape. The company’s ability to address the FDA’s feedback on the CSR and labeling will be critical.
Aldeyra will host a conference call on December 16, 2025, at 8:00 a.m. ET to discuss the PDUFA extension. The company’s focus remains on its innovative therapeutic development for immune-mediated diseases, with reproxalap representing a key late-stage candidate.
About Aldeyra Therapeutics:
Aldeyra Therapeutics is a biotechnology firm dedicated to discovering and developing innovative therapies for immune-mediated diseases. Their core strategy involves creating pharmaceuticals that modulate protein systems, aiming for multi-pathway optimization with reduced toxicity. The company’s product candidates include RASP modulators such as ADX-248 and ADX-246 for systemic and retinal immune-mediated diseases. In addition, Aldeyra is advancing reproxalap for dry eye disease and allergic conjunctivitis, and ADX-2191, a novel formulation of intravitreal methotrexate for primary vitreoretinal lymphoma and retinitis pigmentosa.
Safe Harbor Statement:
This release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995, concerning Aldeyra’s future expectations, plans, and prospects, including anticipated regulatory action timelines and the potential outcome and labeling of the reproxalap New Drug Application for dry eye disease. These statements are based on current expectations and involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is in early development and actual results may differ materially from those projected. Factors that could cause such differences include delays in clinical trials, regulatory review, the ability to obtain and maintain regulatory approval, the success of ongoing and future studies, market acceptance, competition, and other risks detailed in Aldeyra’s filings with the Securities and Exchange Commission (SEC). Aldeyra undertakes no obligation to update forward-looking statements.
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