Key Takeaways
- Aldeyra plans to formally appeal the FDA's March 2026 Complete Response Letter for reproxalap through a Formal Dispute Resolution Request, with submission and a meeting expected in the fourth quarter of 2026
- The company has received 3 complete response letters for the dry eye disease NDA and says it has submitted data from 9 adequate and well-controlled trials
Aldeyra Therapeutics announced plans to submit a Formal Dispute Resolution Request (FDRR) to the FDA regarding reproxalap, its investigational therapy for dry eye disease, following the agency's March 16, 2026, Complete Response Letter (CRL) denying approval of the drug's new drug application (NDA).
The company expects to submit the FDRR and meet with the FDA's Office of New Drugs (OND) in the fourth quarter of 2026. The dispute resolution process is intended to appeal the agency's most recent decision on the reproxalap NDA.
Aldeyra has received 3 CRLs following an initial NDA submission and 2 resubmissions for reproxalap in dry eye disease. According to the company, the first 2 CRLs recommended an additional clinical trial to “demonstrate a positive effect on the treatment of ocular symptoms of dry eye.”
The March 2026 CRL did not request another clinical trial but stated that the “totality of evidence from the completed clinical trials does not support the effectiveness of the product,” according to Aldeyra.
Across the 3 NDA submissions, Aldeyra said it has provided data from 9 adequate and well-controlled clinical trials, 5 of which met all multiplicity-controlled primary endpoints. The company said those results are consistent with or exceed success rates observed in clinical trials conducted for approved dry eye disease therapies.
Aldeyra's decision to pursue formal dispute resolution follows recent Type A and Type D meetings with the FDA's Division of Ophthalmology and Office of Specialty Medicine.
Under Prescription Drug User Fee Act target timelines for the FDRR process, Aldeyra expects a meeting with OND during the fourth quarter. The timing of a subsequent FDA decision remains uncertain and could be affected if the deciding official requests additional information, seeks input from internal or external experts, or convenes an advisory committee.
“We remain steadfast in our commitment to working with the FDA to provide a novel therapeutic approach for the treatment of dry eye disease, a condition often regarded by patients and physicians as inadequately addressed by available therapies,” Todd C. Brady, MD, PhD, president and CEO of Aldeyra Therapeutics, said in a statement.
Dr. Brady added that the company remains optimistic about the dispute resolution process, citing reproxalap's activity across multiple clinical trial designs and what he characterized as discretion applied by the FDA in previous dry eye disease product approvals.
Aldeyra also updated its financial guidance. Based on $45.1 million in reported cash and cash equivalents as of June 30, 2026, the company said it now expects its operational cash runway to extend into 2029.
