Aldeyra Therapeutics resubmits New Drug Application for reproxalap for the treatment of dry eye disease
The resubmission comes after receiving a Complete Response Letter at the end of 2023.
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Aldeyra Therapeutics has resubmitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for topical ocular reproxalap, an investigational new drug candidate in development for the treatment of dry eye disease.
Aldeyra previously received a Complete Response Letter from the FDA at the end of 2023 for reproxalap.
Previously, the company noted that while no safety or manufacturing issues with reproxalap were identified, the FDA stated in the letter that the NDA did not demonstrate “efficacy in treating ocular symptoms associated with dry eyes” and 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.
According to the company, the new NDA contains previously disclosed positive results from a recently completed dry eye disease symptom trial that was requested by the FDA following review of the previously submitted NDA. The application also includes a draft label reflecting acute activity in reducing dry eye symptoms in a dry eye chamber trial, chronic activity in reducing dry eye symptoms in a field trial, and acute activity in reducing ocular redness in two dry eye chamber trials.1
The data mentioned is from the Phase 3 randomized, double-masked, vehicle-controlled dry eye chamber clinical trial of reproxalap in patients with dry eye disease. Results showed that reproxalap was statistically superior to vehicle for the primary endpoint of ocular discomfort (P=0.004).1
Todd C. Brady, MD, PhD, Aldeyra’s President and CEO commented on the NDA in a press release from the company stating, “If approved, reproxalap would have the potential to be the first dry eye disease therapy for chronic use with pivotal data demonstrating acute activity in reducing dry eye symptoms and ocular redness, two characteristics of dry eye disease of primary importance to patients.”
Completion of submission review is expected to be completed within 6 months by the FDA.
Reproxalap is also under development for the treatment of allergic conjunctivitis, a common inflammatory disease that affects an estimated 20% of the worldwide population.
References:
Aldeyra Therapeutics Resubmits Reproxalap New Drug Application for the Treatment of Dry Eye Disease. Press Release; October 3, 2024. Accessed October 3, 2024. https://ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-resubmits-reproxalap-new-drug-application
