Aldeyra Therapeutics completes enrollment in Phase 3 dry eye chamber clinical trial of reproxalap

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The trial is designed to enable a resubmission of a New Drug Application to the US FDA for reproxalap after receiving a Complete Response Letter last year.

(Image Credit: AdobeStock/Monkey Business)

(Image Credit: AdobeStock/Monkey Business)

Aldeyra Therapeutics announced enrollment in its Phase 3 dry eye chamber clinical trial of topical ocular 0.25% reproxalap for the treatment of dry eye disease (DED) has been completed.

The company stated the trial is designed to enable a resubmission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for reproxalap,1 after the FDA issued a Complete Response Letter to their previous submission.

In the previous CRL from the FDA, it was stated “at least one additional adequate and well-controlled study to demonstrate a positive effect on the treatment of ocular symptoms of dry eye” needed to be conducted. After receiving feedback from the FDA on a clinical trial protocol, Aldeyra outlined a path forward earlier this year.

In the Phase 3 clinical trial, 132 patients were enrolled with the primary endpoint of assessing ocular discomfort. In the previous discussions Aldeyra had with the FDA, the FDA noted that ocular discomfort in the dry eye chamber following treatment with reproxalap was statistically lower than that of vehicle (p=0.0003) in 4 previously completed trials.1

Todd C Brady, MD, PhD, president and CEO of Aldeyra, discussed the trial in a press release from the company.

“We believe the rapid enrollment of the Phase 3 clinical trial is consistent with the unmet medical need that exists for patients suffering from dry eye disease,” said Brady. “We anticipate receiving results from the clinical trial in the third quarter of 2024, and, contingent on positive results, we remain on track to resubmit the dry eye disease NDA for reproxalap in the second half of 2024.”

In the potential NDA resubmission, Aldeyra plans to include a draft label for reproxalap describing chronic and acute improvement in symptoms and ocular redness. The company stated that this could be “the first dry eye disease label that incorporates clinical data assessed acutely in a dry eye chamber, and potentially the first dry eye disease label that includes reduction in ocular redness for a chronically administered drug.”1

A Phase 3 clinical trial of reproxalap at a different dry eye chamber and a traditional 6-week field clinical trial are being conducted in parallel.

References:
  1. Aldeyra Therapeutics Completes Enrollment in Phase 3 Clinical Trial of Reproxalap in Dry Eye Disease. Press Release; June 13, 2024. Accessed June 13, 2024. https://www.businesswire.com/news/home/20240613335679/en/Aldeyra-Therapeutics-Completes-Enrollment-in-Phase-3-Clinical-Trial-of-Reproxalap-in-Dry-Eye-Disease
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