Aldeyra Therapeutics outlines clinical development plan for resubmission of reproxalap NDA

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Aldeyra Therapeutics has outlined a clinical development plan for the resubmission of a New Drug Application (NDA) of topical ocular 0.25% reproxalap for the treatment of dry eye disease (DED) to the US Food and Drug Administration (FDA).

Reproxalap is a first-in-class small-molecule modulator of reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory diseases.¹

Previously in November 2023, Aldeyra received a Complete Response Letter (CRL) from the FDA for the NDA of reproxalap. In the CRL the FDA 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. According to the company, feedback was received from the FDA on a clinical trial protocol to assess symptoms in a dry eye chamber.²

The company announced its plans to initiate a dry eye chamber clinical trial in the first half of 2024, with NDA resubmission expected in the second half of 2024 contingent on positive results from the trial.

The proposed dry eye chamber trial will be randomized, double-masked, and vehicle controlled with approximately 100 patients being enrolled. The primary endpoint will be measuring ocular discomfort.²

Furthermore, the design of the trial is based on 4 previously completed dry eye chamber clinical trials with reproxalap. The previous clinical trials showed ocular discomfort in the dry eye chamber following treatment with reproxalap was statistically lower than that of vehicle (p=0.0003).¹

“The planned dry eye chamber clinical trial, if successful, could represent the first pivotal demonstration of rapid improvement in the symptoms of dry eye disease, a potentially debilitating and increasingly pervasive condition that affects millions of patients worldwide,” stated Todd C. Brady, MD, PhD, president and CEO of Aldeyra in a press release from the company.

In addition to the planned clinical trial, a clinical trial at a different dry eye chamber and a 6-week field clinical trial will be conducted in parallel. The company states this is a “comprehensive strategy designed to account for disease heterogeneity and potential differences in clinical sites and environment.”¹

References:

1. Aldeyra Therapeutics Announces Clinical Development Plan for Resubmission of New Drug Application for Reproxalap in Dry Eye Disease. Press release; March 28, 2024. Accessed March 28, 2024. https://ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-announces-clinical-development-plan

2. Aldeyra Therapeutics. Clinical Development Plan for Resubmission of New Drug Application for Reproxalap in Dry Eye Disease. March 28, 2024. Accessed March 28, 2024. https://ir.aldeyra.com/static-files/d273ea2b-f983-4240-8d3e-fe059a611c29