Aldeyra Therapeutics · reproxalap · Mar – Sep 2026
What is Aldeyra appealing, and what had the FDA's 2026 letter recommended?
After Type A and Type D meetings, Aldeyra plans to appeal the March 2026 letter to the FDA's Office of New Drugs on the totality of evidence. The letter's recommendations, as Aldeyra reported them, were to explore reasons for failure and identify populations.
EphemerisX Research · Published · 3 source documents · 2 min read
Short answer
Aldeyra intends to submit a Formal Dispute Resolution Request appealing the March 16, 2026 letter, with a meeting with the Office of New Drugs expected in the fourth quarter of 2026 and a decision whose timing it calls uncertain. In March it reported that the FDA recommended exploring why certain trials failed and identifying populations or conditions where reproxalap may work; the September filing does not mention those recommendations.
What the evidence shows
March 2026: The FDA recommended that the reasons for failure in certain trials be explored, and that populations or certain conditions in which reproxalap may be effective be identified
8-K · Mar 17, 2026. The company's response: Aldeyra does not currently expect to pursue additional clinical trials, and intends to expeditiously request a Type A meeting to understand the actions needed for NDA approval
8-K · Mar 17, 2026.
September 2026: Aldeyra met with the Division of Ophthalmology and the Office of Specialty Medicine at an End of Review Type A meeting and again at a Type D meeting to present arguments supportive of the totality of evidence
8-K · Sep 29, 2026. The request is designed to appeal the March 16, 2026 Complete Response Letter that denied approval of a New Drug Application (NDA) for reproxalap for the treatment of dry eye disease
8-K · Sep 29, 2026.
The press release cites nine adequate and well-controlled clinical trials, five of which achieved all multiplicity-controlled primary endpoints
8-K · Sep 29, 2026, and says the most recent letter did not request further clinical trials
8-K · Sep 29, 2026. The September 2026 filing does not mention the FDA's recommendations to explore reasons for failure and to identify populations or conditions, or the letter's statement on inconsistency. 8-K · searched
On timing: Submission of the FDRR and a meeting with the OND are expected in the fourth quarter of 2026
8-K · Sep 29, 2026; the decision depends on factors the occurrence and timing of which are uncertain
8-K · Sep 29, 2026. The presentation adds: We are aware of two FDRRs in 2026 for ophthalmological drug products: one FDRR resulted in an Appeal Granted decision, and one FDRR is awaiting an advisory panel
8-K · Sep 29, 2026.
Not in this record: the minutes of the Type A and Type D meetings, the dispute resolution request itself, and any filing after September 29, 2026.
Follow the thread
- Did the FDA's 2025 letter ask Aldeyra for the same study as its 2023 letter?Three letters, two asking for another trial
- What changed between the FDA's 2025 and 2026 letters on reproxalap?The FDA's 2026 recommendations
- How does Aldeyra's own trial table record the FDA's position on reproxalap's trials?“Five of which achieved all ... primary endpoints”
This investigation connects to
- What happens after a second FDA Complete Response Letter?Cross-investigation · Divergent outcome · with CorMedix, Outlook Therapeutics, Replimune, Verrica Pharmaceuticals
- What is a Class 1 or Class 2 resubmission, and how did each play out in these records?Cross-investigation · Regulatory pathway · with CorMedix, Outlook Therapeutics, Replimune
- When is one trial enough? How the FDA weighed the evidence in three programsCross-investigation · Comparable evidence · with Outlook Therapeutics, Replimune
The documents, by date
The passages quoted
Aldeyra Therapeutics Form 8-K, filed March 17, 2026
The FDA recommended that the reasons for failure in certain trials be explored, and that populations or certain conditions in which reproxalap may be effective be identified. The FDA did not recommend conducting additional trials or request submission of additional confirmatory evidence. As such, Aldeyra does not currently expect to pursue additional clinical trials, and intends to expeditiously request a Type A meeting to understand the actions needed for NDA approval.Open at the source →
Aldeyra Therapeutics Form 8-K, filed September 29, 2026
The September 2026 filing does not mention the FDA's recommendations to explore reasons for failure and to identify populations or conditions, or the letter's statement on inconsistency.
Open the document →Aldeyra Therapeutics Form 8-K, filed September 29, 2026
The FDRR, which is expected to be reviewed by the FDA’s Office of New Drugs (OND), is designed to appeal the March 16, 2026 Complete Response Letter that denied approval of a New Drug Application (NDA) for reproxalap for the treatment of dry eye disease. Submission of the FDRR and a meeting with the OND are expected in the fourth quarter of 2026.Open at the source →
Aldeyra Therapeutics Form 8-K, filed September 29, 2026
Following an NDA submission and two NDA resubmissions of reproxalap for the treatment of dry eye disease, Aldeyra has received three Complete Response Letters, the first two of which recommended an additional clinical trial to “demonstrate a positive effect on the treatment of ocular symptoms of dry eye” and the most recent of which did not request further clinical trials but stated that the “totality of evidence from the completed clinical trials does not support the effectiveness of the product.” Over the course of the three NDA submissions, Aldeyra has provided data from nine adequate and well-controlled clinical trials, five of which achieved all multiplicity-controlled primary endpoints, consistent with or greater than the success rates of clinical trials conducted for approved dry eye disease products.Open at the source →
Aldeyra Therapeutics Form 8-K, filed September 29, 2026
The timing of the OND FDRR decision will depend on a number of factors, including whether the deciding official requests additional information or determines there is a need to discuss the FDRR with internal or external experts or convene an advisory panel, the occurrence and timing of which are uncertain.Open at the source →
Aldeyra Therapeutics Form 8-K, filed September 29, 2026
Aldeyra met with the Division of Ophthalmology and the Office of Specialty Medicine at an End of Review Type A meeting and again at a Type D meeting to present arguments supportive of the totality of evidence.Open at the source →
Aldeyra Therapeutics Form 8-K, filed September 29, 2026
We are aware of two FDRRs in 2026 for ophthalmological drug products: one FDRR resulted in an Appeal Granted decision, and one FDRR is awaiting an advisory panel.Open at the source →