Aldeyra resubmits NDA for dry eye disease drug after trial success

LEXINGTON, Mass. - Aldeyra Therapeutics, Inc. (NASDAQ:ALDX), whose stock has surged over 12% in the past week according to InvestingPro data, has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration for topical ocular reproxalap to treat signs and symptoms of dry eye disease, according to a company press release. The company, currently valued at approximately $181 million, maintains a strong financial position with more cash than debt on its balance sheet.

The resubmission follows the FDA’s Complete Response Letter issued in April 2025, which cited concerns about methodological issues in a previously completed dry eye chamber trial. The agency had requested an additional symptom trial for resubmission. Despite recent regulatory challenges, InvestingPro data shows the company maintains a healthy current ratio of 6.49, indicating strong ability to meet short-term obligations.

In May 2025, Aldeyra completed a new Phase 3 randomized, double-masked, vehicle-controlled dry eye chamber trial that achieved its primary endpoint with statistical significance (P=0.002) in reducing ocular discomfort, an FDA-accepted symptom of dry eye disease.

"Based on the lack of notable baseline differences across treatment arms and the highly statistically significant achievement of the prespecified primary endpoint in favor of reproxalap over vehicle, we believe that previous concerns raised by the FDA have been addressed," said Todd C. Brady, President and Chief Executive Officer of Aldeyra.

The most common adverse event reported in clinical trials was mild and transient instillation site discomfort, typically lasting less than one minute.

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 candidate has been studied in more than 2,900 patients.

Under Prescription Drug User Fee Act guidelines, the FDA is expected to acknowledge acceptance of the resubmission within 30 days and complete its review within six months.

The information in this article is based on a press release statement from Aldeyra Therapeutics.

In other recent news, Aldeyra Therapeutics has faced significant regulatory challenges concerning its drug candidate, Reproxalap, intended for treating dry eye disease. The company received a Complete Response Letter from the U.S. Food and Drug Administration, indicating that their New Drug Application did not demonstrate adequate efficacy in controlled studies. This setback has prompted Aldeyra to conduct additional trials, with results expected in the second quarter of 2025. Despite these hurdles, several analysts maintain a positive outlook on Aldeyra’s potential. BTIG, Jefferies, Laidlaw, and H.C. Wainwright all continue to endorse a Buy rating, although some have adjusted their price targets. BTIG reduced its target to $9, Jefferies to $6, while Laidlaw and H.C. Wainwright maintain targets at $11 and $10, respectively. The company’s financial position remains stable, with $101 million in cash and equivalents reported at the end of 2024. Aldeyra plans to resubmit its application to the FDA by mid-2025, pending positive trial outcomes.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.