Aldeyra Therapeutics said it plans to submit a Formal Dispute Resolution Request to the U.S. Food and Drug Administration over the rejection of reproxalap, its investigational treatment for dry eye disease. The company expects to submit the request and meet with the FDA’s Office of New Drugs in the fourth quarter of 2026, according to a Sept. 29 regulatory filing.
The dispute follows three Complete Response Letters issued by the FDA after an original New Drug Application and two resubmissions for reproxalap. Aldeyra said the first two letters called for an additional clinical trial to demonstrate a positive effect on ocular symptoms, while the latest letter, issued in March 2026, did not request another trial but said the totality of completed clinical evidence did not support the drug’s effectiveness.
Aldeyra’s decision to pursue the formal dispute process follows recent Type A and Type D meetings with the FDA’s Division of Ophthalmology and Office of Specialty Medicine. The company said it presented arguments supporting the overall evidence for reproxalap during those discussions. The FDA process can involve requests for additional information, internal or external expert consultation or an advisory panel, meaning the timing and outcome of the review remain uncertain.
The company said it submitted data from nine adequate and well-controlled clinical trials across the three NDA submissions. According to Aldeyra’s regulatory presentation, five of those trials achieved all multiplicity-controlled primary endpoints. Those figures represent the company’s characterization of its clinical evidence and do not change the FDA’s current regulatory decision on the application.
The March Complete Response Letter was the third regulatory setback for reproxalap. The FDA said in that decision that the completed clinical evidence did not establish effectiveness, while Aldeyra has continued to argue that the broader data set supports the drug’s potential in dry eye disease. The company has also said the FDA did not identify safety or manufacturing concerns in its review.
Alongside the regulatory strategy, Aldeyra updated its financial outlook. The company reported $45.1 million in cash and cash equivalents as of June 30, 2026, and said that amount is expected to provide an operational cash runway into 2029. The updated runway guidance does not include potential licensing or product revenue associated with reproxalap.
The longer runway gives Aldeyra additional time to pursue the FDA dispute process while advancing its other development programs. The company’s regulatory presentation said it expects to initiate a Phase 3 trial of ADX-2191 in primary vitreoretinal lymphoma in 2027, while other pipeline programs remain at earlier stages of development.
Reproxalap is a topical ocular drug candidate designed for dry eye disease and allergic conjunctivitis and has not been approved by the FDA. Aldeyra said its FDRR will be reviewed by the Office of New Drugs, with the eventual decision dependent on the FDA’s review and any additional information or discussions requested during the process.
The company’s Sept. 29 announcement therefore combines a new regulatory appeal strategy with an extension of its expected operating runway. Both elements remain subject to future regulatory and development outcomes, and Aldeyra cautioned that its projected timelines could change based on regulatory review, funding and clinical-development factors.
