FDA accepts Aldeyra’s resubmitted NDA for dry eye disease drug

LEXINGTON, Mass. - Aldeyra Therapeutics, Inc. (NASDAQ:ALDX), whose stock has surged over 26% in the past year according to InvestingPro data, announced Thursday that the U.S. Food and Drug Administration has accepted its resubmitted New Drug Application for topical ocular reproxalap for the treatment of dry eye disease. The FDA has assigned a PDUFA target action date of December 16, 2025. The company’s shares, currently trading at $5.16, are showing strong momentum with a 7.5% gain in the past week.

The resubmission included data from a clinical trial that met its primary endpoint of reducing ocular discomfort compared to the vehicle control. This additional trial was conducted based on FDA requirements following a previous submission. With a solid current ratio of 6.49 and more cash than debt on its balance sheet, InvestingPro analysis shows Aldeyra is well-positioned to continue its clinical development programs.

"We look forward to a productive dialog with the FDA during the NDA review of reproxalap, which, to our knowledge, remains the only dry eye disease investigational therapy to have demonstrated acute activity in reducing ocular discomfort and redness in pivotal trials," said Todd C. Brady, President and Chief Executive Officer of Aldeyra.

Reproxalap is a first-in-class small-molecule modulator of reactive aldehyde species (RASP), which are elevated in ocular inflammatory diseases. The drug candidate has been studied in more than 2,900 patients with mild and transient instillation site irritation reported as the most common adverse event in clinical trials.

Aldeyra describes reproxalap as potentially addressing two of the largest markets in ophthalmology: dry eye disease and allergic conjunctivitis. The company is also developing other product candidates including ADX-2191, a novel formulation of intravitreal methotrexate for potential treatment of primary vitreoretinal lymphoma and retinitis pigmentosa.

The acceptance of the NDA resubmission comes after Aldeyra conducted the additional clinical trial as required by the FDA to demonstrate the drug’s efficacy in treating dry eye disease symptoms.

This information is based on a press release statement from Aldeyra Therapeutics. Looking ahead, analysts maintain a strong bullish consensus on the stock, with price targets ranging from $6 to $11. InvestingPro offers additional insights with 8 more key tips about Aldeyra’s financial health and market position, available to subscribers.

In other recent news, Aldeyra Therapeutics has secured a Special Protocol Assessment Agreement Letter from the U.S. Food and Drug Administration for its investigational drug ADX-2191, aimed at treating primary vitreoretinal lymphoma (PVRL). The upcoming clinical trial will compare cancer cell clearance in patients receiving either a single or multiple intraocular injections of ADX-2191, with the study set to begin in the second half of 2025 and conclude in 2026. This development follows a Complete Response Letter from the FDA in June 2023, which highlighted the need for controlled trials to demonstrate efficacy. Aldeyra has also resubmitted its New Drug Application for reproxalap, a treatment for dry eye disease, after a successful Phase 3 trial that met its primary endpoint. The FDA is expected to review this resubmission within six months. Additionally, Aldeyra ended the first quarter of 2025 with $90.1 million in cash, which is projected to fund operations through 2026. Analyst Catherine Novack from Jones Trading reiterated a Buy rating on Aldeyra, suggesting that approval of ADX-2191 could open doors for its use in other conditions. These developments signal significant steps forward for Aldeyra in its ongoing efforts to bring new treatments to market.

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