Aldeyra Therapeutics resubmits reproxalap new drug application to FDA for the treatment of dry eye disease

The resubmission includes previously disclosed positive results from a recently completed dry eye disease symptom trial requested by the FDA following review of the previously submitted NDA, as well as 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.

“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,” stated Todd C. Brady, M.D., Ph.D., Aldeyra’s President and Chief Executive Officer.

In August 2024, Aldeyra announced the achievement of the primary endpoint in a Phase III randomized, double-masked, vehicle-controlled dry eye chamber clinical trial of reproxalap in patients with dry eye disease. Reproxalap was statistically superior to vehicle for the prespecified primary endpoint of ocular discomfort (P=0.004), an FDA-accepted symptom of dry eye disease. To Aldeyra’s knowledge, the results represented the first positive Phase III clinical trial in a dry eye chamber with a symptom as a primary endpoint, and Aldeyra believes that results are supportive of the potential rapid clinical effect of reproxalap on reducing the ocular discomfort associated with dry eye disease.