Aldeyra resubmits reproxalap NDA for treatment of dry eye
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Aldeyra Therapeutics has resubmitted a new drug application for topical reproxalap for the treatment of signs and symptoms of dry eye disease, the company announced in a press release.
“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,” Todd C. Brady, MD, PhD, Aldeyra’s president and CEO, said in the release.
According to the release, the resubmission includes previously disclosed positive results from a recent trial, requested by the FDA after review of the previous NDA. In addition, the resubmission includes a draft label describing acute improvement in dry eye symptoms and ocular redness in dry eye chamber trials, as well as chronic improvement in dry eye symptoms in a field trial.
The company recently announced that the primary endpoint was achieved in a phase 3, vehicle-controlled dry eye chamber trial, in which reproxalap was statistically superior to vehicle for ocular discomfort in patients with dry eye disease, the release stated.
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