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# FDA Rejects Aldeyra’s Dry Eye Drug Reproxalap
- URL: https://www.fdaweb.com/fda-rejects-aldeyras-dry-eye-drug-reproxalap/
- Published: 2026-03-17T12:00:00.000Z
- Updated: 2026-09-14T13:35:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160833

FDA has issued Aldeyra a complete response letter (CRL) for its investigational dry eye treatment reproxalap, concluding that the company failed to provide sufficient evidence the drug is effective. The action is the third CRL issued during its regulatory history, and it follows a three-month review extension by the agency in December.

In its decision, FDA said the NDA did not include “substantial evidence” from adequate and well-controlled studies demonstrating that reproxalap improves the signs and symptoms of dry eye disease. The agency also raised concerns about inconsistent trial results, stating that the overall body of clinical data does not support the drug’s effectiveness. Notably, the agency did not identify any safety or manufacturing issues — continuing a pattern seen in prior reviews — indicating that the rejection was driven solely by efficacy concerns.

According to the CRL, variability across clinical trials cast doubt on the reliability and clinical significance of positive findings. The agency emphasized that inconsistencies in study outcomes raised “serious concerns” about whether the drug delivers meaningful benefit to patients, according to the company.

Despite those concerns, FDA reportedly stopped short of requesting new clinical trials or additional confirmatory data. Instead, regulators recommended that Aldeyra further analyze why certain studies failed and identify patient populations or conditions where the drug may show clearer benefit.

Aldeyra said it does not currently plan to initiate new trials but intends to request a Type A meeting with FDA to clarify a potential path forward.

The 6/2025 resubmission of reproxalap addressed an agency complete response letter sent 4/2025 that found the NDA “failed to demonstrate efficacy in adequate and well-controlled studies in treating ocular symptoms associated with dry eye,” according to the company. That letter requested that one additional study be conducted to demonstrate a positive effect, and the company had earlier said its resubmission included new clinical data from a recently completed dry eye chamber trial, which achieved the primary endpoint.