Aldeyra Therapeutics has announced that the US Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for reproxalap, a topical ocular treatment developed for dry eye disease.

阿尔德亚治疗公司宣布，美国食品药品监督管理局（FDA）已接受重新提交的雷帕沙普新药申请（NDA），这是一种用于治疗干眼症的局部眼科药物。

Dry eye disease is a common condition that occurs when the eyes do not produce enough tears or when the tears evaporate too quickly. This leads to inflammation and damage to the surface of the eye. People with dry eye disease often experience symptoms such as stinging, burning, redness, blurred vision, and a gritty sensation in the eyes..

干眼症是一种常见疾病，当眼睛泪液分泌不足或泪液蒸发过快时会发生这种情况。这会导致眼部表面的炎症和损伤。干眼症患者常出现刺痛、灼热感、发红、视力模糊以及眼中有异物感等症状。

Reproxalap is a first-in-class investigational small molecule designed to modulate reactive aldehyde species (RASP), which are linked to ocular and systemic inflammation. It is being developed for both dry eye disease and allergic conjunctivitis—two of the most common conditions in ophthalmology.

Reproxalap 是一种首创的研究性小分子，旨在调节与眼部和全身炎症相关的活性醛类物质 (RASP)。它正被开发用于治疗干眼病和过敏性结膜炎——这是眼科最常见的两种疾病。

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of 16 December 2025.

FDA 已将处方药使用者费用法案（PDUFA）的目标行动日期定为 2025 年 12 月 16 日。

The NDA resubmission follows the FDA’s previous request for an additional clinical trial demonstrating reproxalap’s effectiveness in reducing symptoms of dry eye disease. The revised application includes data from a single trial that successfully met its primary endpoint, showing a reduction in ocular discomfort when compared to a vehicle control..

新药申请（NDA）的重新提交是遵循美国食品药品监督管理局（FDA）此前要求提供额外临床试验数据的请求，以证明reproxalap在减轻干眼病症状方面的有效性。修订后的申请包含了一项成功达到其主要终点的试验数据，与对照组相比，该药物显示出眼部不适的减少。

The investigational therapy has been tested in more than 2,900 individuals across multiple late-stage clinical studies. The results have shown statistically significant and clinically meaningful effects without major safety concerns.

该研究性疗法已在多个后期临床研究中对超过2900名个体进行了测试。结果显示具有统计学显著性和临床意义的效果，且没有重大安全隐患。

The most frequently reported side effect was mild and temporary irritation at the site of application.

最常报告的副作用是应用部位出现轻微且短暂的刺激。