Aldeyra Therapeutics has officially resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for topical ocular reproxalap, targeting both the signs and symptoms of dry eye disease (DED).

阿尔德伊拉治疗公司已正式重新向美国食品和药物管理局 (FDA) 提交了其新药申请 (NDA)，用于局部眼部用药 reproxalap，针对干眼病 (DED) 的症状和体征。

New Data Aligned with FDA Guidance

新数据与FDA指南一致

According to Aldeyra, the only new clinical data included in the NDA resubmission were derived from a recently completed dry eye chamber trial, which successfully met its prespecified primary endpoint as agreed upon with the FDA.

根据Aldeyra的说法，NDA重新提交中包含的唯一新临床数据来自于最近完成的干眼症试验，该试验成功达到了与FDA商定的预定主要终点。

“Consistent with a number of clinical trials that suggest the potential of reproxalap to rapidly improve the symptoms of dry eye disease, we believe the clinical trial results included in the resubmission announced today are robust,” stated Todd C. Brady, MD, PhD, President and CEO of Aldeyra. “In conjunction with recent FDA discussions, we believe that previous concerns raised by the FDA have been addressed.”.

“与多项临床试验一致，这些试验表明reproxalap有潜力快速改善干眼病的症状，我们相信今天宣布的重新提交中包含的临床试验结果是强有力的，”Aldeyra公司总裁兼首席执行官Todd C. Brady医学博士表示，“结合最近与FDA的讨论，我们认为之前FDA提出的担忧已经得到了解决。”

Addressing FDA's Previous Concerns

解决FDA之前的担忧

The resubmission follows a Complete Response Letter (CRL) received in April 2025, which cited potential methodological issues in a previously completed dry eye chamber trial. Specifically, the FDA had noted baseline differences across treatment arms, potentially impacting result interpretation. The CRL requested an additional symptom trial to support a future NDA resubmission..

重新提交的申请是在2025年4月收到完整回应函（CRL）之后进行的，该函指出此前完成的干眼症试验中存在潜在的方法学问题。具体而言，FDA指出各治疗组之间基线存在差异，这可能会影响结果的解读。CRL要求额外进行一项症状试验，以支持未来的新药申请（NDA）重新提交。

Positive Phase 3 Results Support Resubmission

阳性III期结果支持重新提交

In May 2025, Aldeyra announced successful achievement of the primary endpoint in a phase 3 randomized, double-masked, vehicle-controlled dry eye chamber trial evaluating reproxalap’s ability to reduce ocular discomfort.

2025年5月，阿尔迪拉宣布在一项三期随机、双盲、载体对照的干眼症试验中，成功达成了评估雷普罗沙帕减轻眼部不适能力的主要终点。

Key findings include:

主要发现包括：

• Statistically significant improvement in ocular discomfort scores with reproxalap (n=58) versus vehicle (n=58)

• 与安慰剂（n=58）相比，使用Reproxalap（n=58）在眼部不适评分上有统计学意义上的显著改善

• P=0.002 for the prespecified endpoint measured 80–100 minutes after chamber entry

• P=0.002，用于在进入舱室后80-100分钟测量的预定终点指标

• LS mean difference [95% CI]: 6.5 [10.5, 2.5]

• LS 均值差异 [95% CI]：6.5 [10.5, 2.5]

• No safety concerns identified

• 未发现安全问题

• Most common adverse event: mild, transient instillation site discomfort, typically lasting less than one minute

最常见的不良事件：轻度、短暂的滴注部位不适，通常持续不到一分钟

Next Steps Under PDUFA Guidelines

PDUFA指南下的下一步

Per Prescription Drug User Fee Act (PDUFA) timelines, the FDA is expected to acknowledge acceptance for review within 30 days of submission and complete its review within 6 months.

根据《处方药使用者付费法案》（PDUFA）时间表，FDA预计会在提交后30天内确认接受审查，并在6个月内完成审查。