LEXINGTON, Mass. — Aldeyra Therapeutics said it has received a Complete Response Letter from the U.S. Food and Drug Administration for its New Drug Application seeking approval of reproxalap as a treatment for dry eye disease, with regulators citing insufficient evidence of efficacy.
The FDA stated in the letter that there is “a lack of substantial evidence consisting of adequate and well-controlled investigations … that the drug product will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in its proposed labeling” and that “the application has failed to demonstrate efficacy in adequate and well controlled studies in the treatment of signs and symptoms of dry eye disease.” The agency also noted that the “inconsistency of study results raises serious concerns about the reliability and meaningfulness of the positive findings” and that the “totality of evidence from the completed clinical trials does not support the effectiveness of the product.” No safety or manufacturing concerns were identified.
The company said draft labeling had been provided by the FDA in December 2025 and again in March 2026, though Aldeyra does not believe label negotiations were completed during the review process.
The FDA recommended further analysis to better understand why certain trials failed and to identify patient populations or conditions in which reproxalap may be effective. The agency did not request additional clinical trials or new confirmatory evidence. Aldeyra said it does not currently plan to initiate new trials and intends to request a Type A meeting with the FDA to determine the next steps for potential approval. Under Prescription Drug User Fee Act guidelines, such meetings are typically scheduled within 30 days of a request.
“To the thousands of American and Canadian patients who participated in our clinical trials and to the tens of millions of patients with dry eye disease worldwide, I want to assure you that we will work with urgency to support the FDA in enabling market access to what is, to our knowledge, the only drug with clinical activity within minutes of administration in patients with dry eye disease, a condition that is today treated with medications that require weeks or months of treatment to achieve even modest improvement,” said Todd C. Brady, M.D., Ph.D., president and chief executive officer of Aldeyra.
As of December 31, 2025, the company reported $70 million in cash, cash equivalents, and marketable securities, which it said is expected to fund operations into 2028.
