The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for reproxalap for the treatment of the signs and symptoms of dry eye disease.
Reproxalap covalently binds to free aldehydes and diminishes excessive reactive aldehyde species (RASP) levels, which are generally elevated in ocular and systemic inflammatory disease. The NDA is supported by efficacy and safety data from 5 clinical trials, including the phase 3 TRANQUILITY-2 study (ClinicalTrials.gov Identifier: NCT05062330), which included 361 patients with dry eye disease.
Findings from TRANQUILITY-2 showed that reproxalap was statistically superior to vehicle for each of the 2 prespecified primary endpoints, Schirmer test (a measure of ocular tear production; P =.0001) and 100mm or greater Schirmer test responder proportions (P <.0001) after a single day of dosing.
In a phase 2 study (ClinicalTrials.gov Identifier: NCT05102409), patient-reported ocular discomfort and itching were found to be statistically lower in patients treated with reproxalap than with lifitegrast, an FDA-approved treatment for dry eye disease.
Across all clinical trials, the most common adverse event reported with reproxalap was instillation site irritation. No clinically significant safety concerns were observed.
“NDA acceptance marks a critical regulatory milestone for Aldeyra as reproxalap continues to advance toward potential regulatory approval for the treatment of dry eye disease,” said Todd C. Brady, MD, PhD, President and CEO of Aldeyra. “Based on data from a number of late-stage clinical trials, we believe reproxalap has the potential to address the need for a rapid and durable ophthalmic therapy for the millions of dry eye disease patients who are dissatisfied with currently available therapies.”
A Prescription Drug User Fee Act target date of November 23, 2023 has been set for the application.
- Aldeyra Therapeutics announces FDA acceptance of New Drug Application for reproxalap for the treatment of dry eye disease. News release. Aldeyra Therapeutics. Accessed February 7, 2023. https://www.businesswire.com/news/home/20230206005693/en/Aldeyra-Therapeutics-Announces-FDA-Acceptance-of-New-Drug-Application-for-Reproxalap-for-the-Treatment-of-Dry-Eye-Disease.
- Aldeyra Therapeutics achieves primary endpoint in phase 3 TRANQUILITY‑2 trial in dry eye disease and intends to submit New Drug Application for symptoms and three sign endpoints of dry eye disease. News release. Aldeyra Therapeutics. June 8, 2022. Accessed February 7, 2023. https://ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-achieves-primary-endpoint-phase-3.
- Aldeyra Therapeutics announces positive top-line data from phase 2 dry eye chamber clinical trial of reproxalap, an investigational new drug, compared to Xiidra. News release. Aldeyra Therapeutics. January 11, 2022. Accessed February 7, 2023. https://ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-announces-positive-top-line-data-phase-2.
This article originally appeared on MPR