Aldeyra plans FDA appeal for reproxalap dry eye treatment application

• Aldeyra Therapeutics plans to submit a Formal Dispute Resolution Request (FDRR) to the FDA regarding the rejection of reproxalap for dry eye disease.
• The appeal will challenge the FDA’s March 2026 Complete Response Letter, which denied approval of the drug candidate.
• Aldeyra extended its expected cash runway into 2029, supported by $45.1 million in cash and cash equivalents as of June 30, 2026.

Aldeyra Therapeutics (NASDAQ:ALDX) announced plans to submit a Formal Dispute Resolution Request (FDRR) to the U.S. Food and Drug Administration (FDA) seeking review of the agency’s decision not to approve reproxalap, its investigational therapy for dry eye disease.

The FDRR is expected to be reviewed by the FDA’s Office of New Drugs (OND) and is intended to appeal the March 16, 2026 Complete Response Letter (CRL) that denied approval of Aldeyra’s New Drug Application (NDA) for reproxalap.

Aldeyra expects to submit the FDRR and hold a meeting with the OND during the fourth quarter of 2026.

The timing of the FDA’s decision will depend on factors including whether additional information is requested, whether internal or external experts are consulted, or whether an advisory panel is convened.

The company said it has received three CRLs related to reproxalap following an initial NDA submission and two resubmissions.

Aldeyra noted that the first two FDA responses requested additional clinical evidence, while the most recent CRL stated that the overall clinical evidence did not support effectiveness.

Aldeyra said it has submitted data from nine adequate and well-controlled clinical trials across the three NDA submissions, including five trials that achieved all multiplicity-controlled primary endpoints.

The decision to pursue an FDRR followed recent Type A and Type D meetings with the FDA Division of Ophthalmology and the Office of Specialty Medicine.

Separately, Aldeyra updated its financial outlook, stating that cash and cash equivalents of $45.1 million as of June 30, 2026, support an extension of its operational runway into 2029.