Aldeyra Therapeutics announced on October 3, 2024, the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap. This investigational drug candidate is intended for the treatment of the signs and symptoms of dry eye disease. The resubmission follows a previous Complete Response Letter from the FDA, which had requested additional efficacy data.
The updated NDA includes positive results from a recently completed dry eye disease symptom trial, which was specifically requested by the FDA. Additionally, the submission features a draft label that highlights reproxalap's acute activity in reducing dry eye symptoms in a dry eye chamber trial, chronic activity in a field trial, and acute activity in reducing ocular redness in two dry eye chamber trials. These data points aim to demonstrate the drug's comprehensive efficacy profile.
According to FDA guidelines, the company expects an acknowledgment of acceptance for review within 30 days of submission, with the full review process anticipated to conclude within six months. This resubmission is a pivotal step for Aldeyra, as reproxalap, if approved, could be the first dry eye disease therapy for chronic use with pivotal data demonstrating acute activity in reducing both symptoms and ocular redness.
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