Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Aldeyra Therapeutics for its new drug application (NDA) of reproxalap to treat dry eye disease.
Aldeyra Therapeutics will not pursue new trials and will request a Type A meeting with the FDA. Credit: Sai Thaw Kyar / Shutterstock.com.
Subscribe to our email newsletter
This CRL stated that the application lacks substantial evidence of efficacy from adequate and well-controlled clinical investigations under the proposed conditions of use.
The FDA noted inconsistencies in study results, raising concerns about the meaningfulness and reliability of positive outcomes.
The letter also stated that the totality of evidence from completed studies does not support reproxalap’s effectiveness for dry eye disease. However, the review did not identify any safety or manufacturing issues related to the product.
During the review process, the FDA provided label drafts in December 2025 and March 2026. Aldeyra Therapeutics noted that label negotiations were not completed.
The agency recommended further exploration into reasons for failure in certain trials and suggested identifying populations or conditions where reproxalap may be effective.
The FDA did not advise conducting additional trials or request further confirmatory evidence at this time.
As a result, the company does not expect to pursue new trials and plans to request a Type A meeting with the agency to clarify actions required for approval.
The target date for this meeting is within 30 days of receipt of the meeting request, in line with Prescription Drug User Fee Act goals.
Aldeyra Therapeutics president and CEO Todd Brady said: “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.”
As of 31 December 2025, Aldeyra Therapeutics reported cash, cash equivalents, and marketable securities totalling $70m, which are expected to support operations into 2028.
