Aldeyra to challenge FDA rejection of dry eye drug reproxalap

Aldeyra Therapeutics (Nasdaq: ALDX) announced plans to submit a Formal Dispute Resolution Request (FDRR) to the U.S. Food and Drug Administration appealing the rejection of its dry eye disease drug reproxalap.

The FDA issued a Complete Response Letter on March 16, 2026, denying approval of the New Drug Application for reproxalap, stating that the "totality of evidence from the completed clinical trials does not support the effectiveness of the product." It was the third such rejection Aldeyra has received for the drug, following an original NDA submission and two resubmissions.

The FDRR is expected to be reviewed by the FDA's Office of New Drugs. Aldeyra said it expects to submit the FDRR and hold a meeting with that office in the fourth quarter of 2026.

Across the three NDA submissions, Aldeyra provided data from nine clinical trials, five of which it said achieved all multiplicity-controlled primary endpoints. The first two rejection letters had recommended an additional clinical trial, while the most recent did not request further trials.

The company said its decision to pursue the FDRR follows Type A and Type D meetings with the FDA Division of Ophthalmology and the Office of Specialty Medicine.

Aldeyra also updated its financial guidance, saying cash and cash equivalents of $45.1 million as of June 30, 2026, support an operational cash runway into 2029.

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