FDA Accepts Resubmitted Marketing Application for Aldeyra's Lead Dry Eye Disease Drug

Aldeyra Therapeutics announced that the FDA has accepted for review its resubmitted NDA for reproxalap, a drug for dry eye disease. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 30, 2023. The company's shares surged 18% in pre-market trading following the announcement.

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical ocular reproxalap. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2025. The company's shares surged 18% in pre-market trading following the announcement.

Reproxalap is a first-in-class investigational new drug candidate designed to treat the signs and symptoms of dry eye disease. It is a small-molecule modulator of RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory diseases. The drug has demonstrated statistically significant and clinically relevant activity in multiple physiologically distinct late-phase clinical indications. Reproxalap has been studied in more than 2,900 patients with no observed safety concerns; mild and transient instillation site irritation is the most commonly reported adverse event in clinical trials.

Aldeyra Therapeutics is a biotechnology company focused on discovering innovative therapies for immune-mediated and metabolic diseases. The company's approach involves developing pharmaceuticals that modulate protein systems to optimize multiple pathways simultaneously while minimizing toxicity. Reproxalap is one of Aldeyra's late-stage product candidates, along with ADX-2191, a novel formulation of intravitreal methotrexate for the potential treatment of primary vitreoretinal lymphoma and retinitis pigmentosa.

The FDA's acceptance of the NDA for reproxalap marks a significant milestone for Aldeyra Therapeutics. The company anticipates a productive dialogue with the FDA during the NDA review process. If approved, reproxalap could become the first dry eye disease investigational therapy to demonstrate acute activity in reducing ocular discomfort and redness in pivotal trials, setting it apart from existing treatments.

Investors and financial professionals should note that Aldeyra Therapeutics' stock price surged following the announcement, reflecting market optimism about the potential success of reproxalap. However, the company's development timelines may be subject to adjustment depending on various factors, including recruitment rates, regulatory review, preclinical and clinical results, funding, and other uncertainties.

References:
[1] https://www.morningstar.com/news/business-wire/20250717410973/aldeyra-therapeutics-announces-fda-acceptance-for-review-of-reproxalap-new-drug-application-for-the-treatment-of-dry-eye-disease
[2] https://www.businesswire.com/news/home/20250717410973/en/Aldeyra-Therapeutics-Announces-FDA-Acceptance-for-Review-of-Reproxalap-New-Drug-Application-for-the-Treatment-of-Dry-Eye-Disease