Aldeyra's Reproxalap NDA Accepted for Review by FDA for Dry Eye Disease Treatment

Aldeyra Therapeutics announced that the FDA has accepted for review the resubmitted new drug application for topical ocular reproxalap, a treatment for dry eye disease. The FDA assigned a Prescription Drug User Fee Act target action date of December 16.

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) has announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ocular reproxalap, an investigational new drug candidate for the treatment of the signs and symptoms of dry eye disease. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2025 [1].

Reproxalap is a first-in-class small-molecule modulator of reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory diseases. The drug has demonstrated statistically significant and clinically relevant activity in reducing ocular discomfort and redness in pivotal trials simulating the disease flares that are likely the most bothersome aspects of dry eye disease [2].

In response to the FDA's requirement for an additional clinical trial, Aldeyra conducted a randomized, double-masked, vehicle-controlled dry eye chamber trial (ClinicalTrials.gov Identifier: NCT06493604). The study evaluated reproxalap ophthalmic solution 0.25% in 116 patients with dry eye disease. The findings showed that reproxalap 0.25% was superior to vehicle-control in reducing ocular discomfort, as assessed by ocular discomfort symptom score, from 80 to 100 minutes after chamber entry (least squares mean difference, -6.5 [95% CI, -10.5, -2.5]; P =.002) [1].

The most common adverse event reported was mild instillation site discomfort, usually lasting less than 1 minute. "We look forward to a productive dialogue with the FDA during the NDA review of reproxalap," stated Todd C. Brady, MD, PhD, President and Chief Executive Officer of Aldeyra [1].

Aldeyra Therapeutics is a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated and metabolic diseases. The company's approach involves developing pharmaceuticals that modulate protein systems, aiming to optimize multiple pathways at once while minimizing toxicity [2].

References:

[1] https://www.empr.com/news/reproxalap-faces-third-fda-review-for-dry-eye-disease/
[2] https://www.lelezard.com/en/news-21891180.html