Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for reproxalap, an investigational treatment for dry eye disease.
The FDA advised that the reasons for the drug’s failure in certain trials should be investigated, and that specific populations or conditions where reproxalap might be effective should be identified. However, the FDA did not recommend additional clinical trials or request further confirmatory evidence.
The CRL noted a lack of substantial evidence from adequate and well-controlled studies to demonstrate that reproxalap is effective for treating the signs and symptoms of dry eye disease as proposed in its labeling.
During the NDA review process, the FDA provided label drafts in December 2025 and March 2026. Aldeyra stated that it does not believe the label negotiations were finalized.
Aldeyra currently does not plan to conduct further clinical trials and intends to promptly request a Type A meeting with the FDA to clarify the steps required for NDA approval.
As of December 31, 2025, Aldeyra reported having $70 million in cash, cash equivalents, and marketable securities, which it expects will fund operations through 2028.
In pre-market trading, shares of Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) fell 73.29% to $1.13, a decrease of $3.10 from the previous close of $4.13. The stock continues to trade within its 52-week range of $1.14 to $7.01.
 received a Complete Response Letter from the FDA regarding its reproxalap NDA for dry eye disease, citing insufficient evidence of efficacy.){kind=link}