Aldeyra Therapeutics Tanks In Pre-Market As FDA Denies Reproxalap's NDA Resubmission

(RTTNews) - Aldeyra Therapeutics, Inc. (ALDX), Thursday announced that the company has received a Complete Response Letter from the U.S. Food and Drug Administration for the re-submission of the New Drug Application of reproxalap for the treatment of dry eye disease and allergic conjunctivitis.

In the letter, the FDA stated that the NDA "failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes".

Moreover, the agency recommended that "at least one additional adequate and well controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye" should be conducted.

Further, the FDA pointed out concerns with the data from the trial submitted to the NDA that may have affected interpretation of the results, which might be related to methodological issues, including a difference in baseline scores across treatment arms.

The company expects a Type A meeting to be held within approximately 30 days to discuss further about the letter and the ongoing clinical trials of reproxalap in dry eye disease.

Earlier, Aldeyra submitted an NDA in November 2022 supported by data from two two trials for ocular redness in a dry eye chamber, and two dry eye disease symptom field trials.

In response to the initial NDA, the FDA stated that at least one additional symptom trial was required.

Following this, 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, the biotechnology company 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. Notably, Aldeyra expects to announce top-line results from the ongoing dry eye disease field trial and the ongoing chamber clinical trial in the second quarter of 2025, with a potential re-submission of NDA in mid-year 2025. The company expects the review period for the potential NDA resubmission to be six months.

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

In the pre-market hours, Aldeyra's stock is plummeting 73.71 percent, to $1.40 on the Nasdaq.