CONCORD, Mass. — September 29, 2026
Aldeyra Therapeutics announced plans to submit a Formal Dispute Resolution Request (FDRR) to the U.S. Food and Drug Administration (FDA) seeking review of the March 16, 2026 Complete Response Letter that denied approval of reproxalap for dry eye disease. The request is expected to be submitted in the fourth quarter of 2026 and reviewed by the FDA’s Office of New Drugs (OND). Aldeyra’s decision follows recent Type A and Type D meetings with the FDA Division of Ophthalmology and Office of Specialty Medicine. The company has received three Complete Response Letters across its NDA and two resubmissions for reproxalap, with the latest letter stating that the totality of evidence from completed clinical trials did not support effectiveness.
Aldeyra Seeks Review of Reproxalap Dry Eye Decision
The planned FDRR is intended to formally appeal the FDA’s most recent regulatory decision on reproxalap, an investigational therapy being developed for dry eye disease. According to Aldeyra, the first two Complete Response Letters recommended an additional clinical trial to demonstrate a positive effect on ocular symptoms, while the March 2026 letter did not request another clinical trial but concluded that the completed evidence did not establish effectiveness. Across its three NDA submissions, Aldeyra said it provided data from nine adequate and well-controlled clinical trials, including five trials that achieved all multiplicity-controlled primary endpoints. The company believes the broader clinical dataset supports reconsideration, although the FDA’s prior determination remains that the totality of evidence did not support approval.
FDA OND Meeting Expected in Fourth Quarter
Aldeyra expects to submit the FDRR and meet with the FDA’s Office of New Drugs during the fourth quarter of 2026. The dispute-resolution process is governed by FDA procedures and PDUFA target timelines, but the timing and outcome of the review remain uncertain. The deciding official may request additional information, seek input from internal or external experts or determine that an advisory committee discussion is appropriate. The company said the FDRR decision will therefore depend on the FDA’s review of the request and any additional procedural steps. Aldeyra’s management has expressed optimism regarding the potential outcome based on the company’s interpretation of reproxalap clinical data, but that view is not an FDA determination.
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Aldeyra Extends Cash Runway Into 2029
Aldeyra also updated its financial guidance, stating that reported cash and cash equivalents of $45.1 million as of June 30, 2026 are expected to support an operational cash runway into 2029. Reproxalap is a late-stage RASP (reactive aldehyde species) modulator being developed for dry eye disease and allergic conjunctivitis. Aldeyra’s broader pipeline includes ADX-248 and related RASP modulators for systemic and retinal immune-mediated diseases, as well as ADX-2191, an intravitreal methotrexate formulation being developed for primary vitreoretinal lymphoma. The FDRR represents a regulatory appeal rather than an approval or a new clinical efficacy result, and reproxalap remains investigational pending further FDA action.
Source :Aldeyra Therapeutics, press release
