The U.S. Meals and Drug Administration (FDA) on Thursday issued a Full Response Letter for Aldeyra Therapeutics, Inc.’s ALDX resubmission of the New Drug Software (NDA) of reproxalap, an investigational drug candidate, for dry eye illness.
The FDA acknowledged that the NDA “didn’t exhibit efficacy in enough and well-controlled research in treating ocular signs related to dry eyes” and that “at the least one extra enough and well-controlled examine to exhibit a constructive impact on the remedy of ocular signs of a dry eye” ought to be carried out.
The letter recognized considerations with the trial information submitted to the NDA which will have affected the interpretation of the outcomes.
The FDA acknowledged that these considerations could also be associated to methodological points, together with a distinction in baseline scores throughout remedy arms.
The company stated no manufacturing or issues of safety with reproxalap had been recognized.
Per draft FDA dry eye illness steering, to be thought of for regulatory approval in the USA, efficacy in dry eye illness could also be demonstrated with two symptom and two signal trials.
Amongst different scientific trials of reproxalap, Aldeyra beforehand carried out two trials for ocular redness (a dry eye illness signal) in a dry eye chamber and two dry eye illness symptom discipline (environmental publicity) trials, which had been submitted as a part of an preliminary NDA in November 2022.
In November 2023, the FDA issued a Full Response Letter to the preliminary NDA stating that at the least one extra symptom trial was required.
Aldeyra initiated three scientific trials assessing dry eye illness signs: a dry eye chamber trial, a scientific trial in a distinct dry eye chamber, and a six-week discipline trial.
In August 2024, Aldeyra introduced the achievement of the first endpoint within the first dry eye chamber scientific trial of reproxalap, and the NDA was resubmitted in October 2024.
Aldeyra expects to announce topline outcomes from the continuing dry eye illness discipline trial and the chamber scientific trial within the second quarter of 2025.
Aldeyra intends to resubmit the NDA by mid-year 2025. The assessment interval for the potential NDA resubmission is predicted to be six months.
As of December 31, 2024, Aldeyra reported $101 million in money, money equivalents, and marketable securities.
Worth Motion: ALDX inventory is down 74.5% at $1.36 through the premarket session on the final examine Thursday.
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