FDA Rejects Aldeyra's Reproxalap For Dry Eye Disease Again, Citing Efficacy Concerns

The U.S. Food and Drug Administration (FDA) on Thursday issued a Complete Response Letter for Aldeyra Therapeutics, Inc.’s ALDX resubmission of the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for dry eye disease.

The FDA stated that the NDA “failed to demonstrate efficacy in adequate and well-controlled studies in treating ocular symptoms associated with dry eyes” and that “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of a dry eye” should be conducted.

The letter identified concerns with the trial data submitted to the NDA that may have affected the interpretation of the results.

The FDA stated that these concerns may be related to methodological issues, including a difference in baseline scores across treatment arms.

The agency said no manufacturing or safety issues with reproxalap were identified.

Per draft FDA dry eye disease guidance, to be considered for regulatory approval in the United States, efficacy in dry eye disease may be demonstrated with two symptom and two sign trials.

Among other clinical trials of reproxalap, Aldeyra previously conducted two trials for ocular redness (a dry eye disease sign) in a dry eye chamber and two dry eye disease symptom field (environmental exposure) trials, which were submitted as part of an initial NDA in November 2022.

In November 2023, the FDA issued a Complete Response Letter to the initial NDA stating that at least one additional symptom trial was required.

Aldeyra initiated three clinical trials assessing dry eye disease symptoms: a dry eye chamber trial, a clinical trial in a different dry eye chamber, and a six-week field trial.

In August 2024, Aldeyra announced the achievement of the primary endpoint in the first dry eye chamber clinical trial of reproxalap, and the NDA was resubmitted in October 2024.

Aldeyra expects to announce topline results from the ongoing dry eye disease field trial and the chamber clinical trial in the second quarter of 2025.

Aldeyra intends to resubmit the NDA by mid-year 2025. The review period for the potential NDA resubmission is expected to be six months.

As of December 31, 2024, Aldeyra reported $101 million in cash, cash equivalents, and marketable securities.

Price Action: ALDX stock is down 74.5% at $1.36 during the premarket session at the last check Thursday.

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