Aldeyra Therapeutics, Inc. announced on September 29, 2026, its intent to submit a Formal Dispute Resolution Request (FDRR) to the U.S. Food and Drug Administration’s Office of New Drugs (OND). This move follows a Complete Response Letter issued on March 16, 2026, which denied approval of a New Drug Application (NDA) for reproxalap, a topical ocular drug candidate for the treatment of dry eye disease.
The company stated that the FDA’s decision did not request additional clinical trials but concluded that the "totality of evidence from the completed clinical trials does not support the effectiveness of the product." Aldeyra disputes this finding. The company notes that over the course of three NDA submissions, it provided data from nine adequate and well-controlled clinical trials. According to the filing, five of these trials achieved all multiplicity-controlled primary endpoints, and the P-values for 9 of 14 endpoints were less than 0.05.
Aldeyra held a Type D meeting with the FDA on September 25, 2026, to discuss the matter. Following this meeting, the company plans to submit the FDRR in the fourth quarter of 2026. The company expects to meet with the OND regarding this request in the same quarter. The outcome of the FDRR decision is subject to various factors, including whether the deciding official requests additional information or convenes an advisory panel.
In addition to the regulatory update, Aldeyra reported that it has extended its projected operational cash runway into 2029. The company is scheduled to hold a conference call on September 29, 2026, to discuss these developments.
