Aldeyra Therapeutics (ALDX) has announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for their investigational topical ocular therapy, reproxalap. This drug candidate is aimed at treating the symptoms and signs associated with dry eye disease. The resubmission incorporates promising outcomes from a recent dry eye disease symptom study, as requested by the FDA after an initial review of the previous NDA. Additionally, the application includes a proposed label that highlights reproxalap's acute efficacy in alleviating symptoms within a dry eye chamber setting, its long-term efficacy in a field trial, and its short-term effectiveness in reducing ocular redness across two dry eye chamber studies.
"If approved, reproxalap holds the potential to become the first chronic-use therapy for dry eye disease, supported by pivotal data showcasing its immediate efficacy in symptom reduction and ocular redness—key concerns for patients suffering from this condition," stated CEO Todd Brady.
