Aldeyra Therapeutics (ALDX, Financial) announced that the U.S. Food and Drug Administration (FDA) has accepted its resubmitted New Drug Application (NDA) for reproxalap, a novel ocular treatment for dry eye disease. The Prescription Drug User Fee Act (PDUFA) target action date is set for April 2, 2025.
Reproxalap is a promising "first-in-class" small molecule inhibitor targeting reactive aldehyde species, which increase during ocular or systemic inflammation. High levels of these species in the eyes can lead to inflammation, reduced tear production, redness, and altered tear lipid composition, common in patients with dry eye disease.
In addition, Aldeyra announced an expansion of its exclusive option agreement with AbbVie, potentially broadening the collaborative development and commercialization efforts for reproxalap.
