ALISO VIEJO, Calif.--(BUSINESS WIRE)--Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and medical technology company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced that the second Phase 3 confirmatory pivotal trial for Epioxa™ (Epi-on), its next-generation corneal cross-linking iLink therapy for the treatment of keratoconus, successfully met the study’s pre-specified primary efficacy endpoint, demonstrating a clinically relevant and statistically significant improvement in maximum corneal curvature (Kmax) at 12 months from baseline between the Epioxa treated arm and the sham/placebo-controlled arm.

加利福尼亚州ALISO VIEJO——（商业新闻短讯）——Glaukos Corporation（纽约证券交易所代码：GKOS）是一家专注于治疗青光眼、角膜疾病和视网膜疾病的新型疗法的眼科制药和医疗技术公司，今天宣布，其用于治疗圆锥角膜的下一代角膜交联iLink疗法Epioxa™（Epi-on）的第二阶段3验证性关键试验成功达到了该研究预先指定的主要疗效终点，证明了Epioxa治疗组和假/安慰剂对照组之间在基线12个月时最大角膜曲率（Kmax）的临床相关和统计学显着改善。

Kmax is a U.S. FDA-accepted primary efficacy outcome for keratoconus pivotal trials and an objective measurement of the steepest corneal curvature based on corneal topography, where an increasing Kmax denotes corneal steepening and keratoconus disease progression..

Kmax是美国FDA接受的圆锥角膜关键试验的主要疗效结果，是基于角膜地形图的最陡角膜曲率的客观测量，其中Kmax增加表示角膜变陡和圆锥角膜疾病进展。。

“We are excited to announce these positive Phase 3 confirmatory results that met the study’s primary efficacy endpoint and once again demonstrated the potential of Epioxa to halt or reduce the advancement of keratoconus, a progressive, sight-threatening corneal disease. These results further underscore our view that Epioxa may provide the ophthalmic community and keratoconus patients with the first FDA-approved, non-invasive, bio-activated drug treatment alternative designed to reduce procedure time, improve patient comfort and shorten recovery time,” said Thomas Burns, Glaukos chairman and chief executive officer.

Glaukos董事长兼首席执行官托马斯·伯恩斯（Thomas Burns）表示：“我们很高兴宣布这些符合研究主要疗效终点的阳性3期确证结果，并再次证明了Epioxa有可能阻止或减少圆锥角膜的进展，圆锥角膜是一种进行性威胁视力的角膜疾病。这些结果进一步强调了我们的观点，即Epioxa可能为眼科社区和圆锥角膜患者提供首个FDA批准的非侵入性生物激活药物治疗替代方案，旨在减少手术时间，提高患者舒适度并缩短恢复时间。”。

“We appreciate the commitment and dedication of the clinical investigators, who play a vital role in bringing new innovations to patients suffering from keratoconus and at risk for significant vision loss. We expect these data to support our anticipated NDA targeted for FDA submission by the end of this year.”.

“我们感谢临床研究人员的承诺和奉献精神，他们在为圆锥角膜患者带来新的创新方面发挥着至关重要的作用，并且有严重视力丧失的风险。我们希望这些数据能够支持我们预期的NDA，目标是在今年年底之前提交FDA。”。

Topline summary results and observations from the Phase 3 confirmatory pivotal trial are as follows:

第三阶段验证性关键试验的总结结果和观察结果如下：

The Epioxa Phase 3 clinical trial successfully achieved its primary efficacy outcome by demonstrating a Kmax treatment effect of –1.0 diopter (D) (p <0.0001), determined as prospectively defined least square mean Kmax change from baseline in the Epioxa treated arm versus the sham/placebo-controlled arm at the Month 12 study endpoint..

Epioxa 3期临床试验通过证明Kmax治疗效果为-1.0屈光度（D）（p<0.0001），成功实现了其主要疗效结果，该治疗效果为在第12个月的研究终点，Epioxa治疗组与假/安慰剂对照组相比，前瞻性定义的最小二乘平均Kmax从基线变化。。

The treatment was generally well-tolerated, with 91.5% of enrolled treatment patients completing the 12-month trial, compared to 90.9% of enrolled control patients. No patients randomized to Epioxa treatment discontinued early due to an adverse event and there were no ocular serious adverse events reported.

该治疗总体上耐受性良好，91.5%的登记治疗患者完成了12个月的试验，而登记对照患者为90.9%。没有随机接受Epioxa治疗的患者因不良事件而提前停止，也没有眼部严重不良事件的报告。

The majority of adverse events reported were mild and transient in nature. There was no evidence of treatment-related systemic effects reported in the study and there was no change in corneal endothelial cell counts over the 12-month evaluation period..

报告的大多数不良事件性质轻微且短暂。研究中没有报道与治疗相关的全身效应的证据，并且在12个月的评估期内角膜内皮细胞计数没有变化。。

The multi-center, randomized, placebo and sham controlled Phase 3 confirmatory pivotal trial randomized 312 eyes and was designed to evaluate the safety and efficacy of Glaukos’ Epioxa therapy in impeding the progression of, and/or reducing Kmax, in eyes with progressive keratoconus. The study eyes were randomized in a 2:1 ratio to receive Epioxa therapy or placebo and sham procedure control treatment.

多中心，随机，安慰剂和假对照的3期验证性关键试验将312只眼随机分组，旨在评估Glaukos Epioxa疗法在阻止和/或减少进行性圆锥角膜患者Kmax进展方面的安全性和有效性。研究对象的眼睛以2:1的比例随机接受Epioxa治疗或安慰剂和假手术对照治疗。

The study’s primary efficacy endpoint was the mean change in Kmax from baseline to Month 12. Based on a special protocol assessment (SPA) agreement with the U.S. FDA, the study was to be considered a success if the difference between the treatment and control arm in the primary efficacy endpoint is statistically significant and the difference is ≥ 1.0 D..

该研究的主要疗效终点是Kmax从基线到第12个月的平均变化。根据与美国FDA的特别方案评估（SPA）协议，如果治疗组和对照组在主要疗效终点之间的差异具有统计学意义且差异≥1.0 D，则该研究被认为是成功的。。

Results from this second Phase 3 confirmatory pivotal trial together with the already-completed first Phase 3 pivotal trial are expected to support Glaukos’ anticipated NDA submission for Epioxa by the end of 2024. As a reminder, the U.S. FDA has confirmed Glaukos’ first Phase 3 pivotal trial for Epioxa, which met the pre-specified primary efficacy endpoint, would be adequate to support the submission and review of an eventual NDA, in conjunction with this second Phase 3 trial..

第二阶段3验证性关键试验的结果以及已经完成的第一阶段3关键试验的结果预计将支持Glaukos在2024年底之前为Epioxa提交预期的NDA。作为提醒，美国FDA已确认Glaukos针对Epioxa的第一个3期关键试验符合预先规定的主要疗效终点，足以支持最终NDA的提交和审查，以及第二个3期试验。。

Glaukos recently completed a successful clinical pre-NDA meeting with the U.S. FDA regarding Epioxa as a novel treatment for keratoconus. The purpose of the meeting was to obtain agreement from the FDA on the content of the proposed NDA, and in particular, to confirm that the company’s clinical data package, including the two completed Phase 3 pivotal studies, would be sufficient to support an NDA submission and review.

Glaukos最近成功完成了与美国FDA关于Epioxa作为圆锥角膜新疗法的NDA前临床会议。会议的目的是获得FDA对拟议NDA内容的同意，特别是确认该公司的临床数据包，包括两项完成的3期关键研究，足以支持NDA提交和审查。

As an outcome of this pre-NDA meeting, the FDA agreed that the proposed clinical data package is sufficient to support an NDA submission and review..

作为这次NDA前会议的结果，FDA同意拟议的临床数据包足以支持NDA的提交和审查。。

Glaukos’ corneal cross-linking iLink therapies use proprietary, bio-activated, single-use drug formulations to strengthen corneal tissue and halt progression of keratoconus. Typically diagnosed in a patient’s teenage years, keratoconus is a debilitating eye condition characterized by progressive thinning and weakening of the cornea.

Glaukos的角膜交联iLink疗法使用专有的生物活化一次性药物制剂来增强角膜组织并阻止圆锥角膜的进展。圆锥角膜通常在患者十几岁时被诊断出，是一种使人衰弱的眼部疾病，其特征是角膜逐渐变薄和变弱。

If left untreated, keratoconus can lead to loss of vision and even blindness and is one of the leading causes of corneal transplant (penetrating keratoplasty) in the United States. Approximately 90% of cases of keratoconus are bilateral and as many as 20% of patients ultimately require a corneal transplant.

如果不及时治疗，圆锥角膜可能导致视力丧失甚至失明，并且是美国角膜移植（穿透性角膜移植）的主要原因之一。大约90%的圆锥角膜病例是双侧的，多达20%的患者最终需要进行角膜移植。

Conventional keratoconus treatments such as eyeglasses or contact lenses address symptoms but Glaukos’ first-generation iLink therapy, known as Photrexa®, or Epi-off, is the first and only FDA-approved therapy that has been shown to slow or halt disease progression. There are more than 300 peer-reviewed publications supporting the performance and safety of Glaukos’ iLink therapy..

。有300多篇同行评审的出版物支持Glaukos的iLink疗法的性能和安全性。。

Epioxa, which is designed to preserve the corneal epithelium, reduce procedure times, improve patient comfort and shorten recovery time, utilizes a proprietary, novel drug formulation designed to penetrate the epithelial layer of the cornea, a stronger UV-A irradiation protocol and the ability to deliver increased levels of supplemental oxygen to enhance cross-linking.

Epioxa旨在保护角膜上皮，减少手术时间，提高患者舒适度并缩短恢复时间，它利用了一种专有的新型药物制剂，旨在穿透角膜上皮层，更强的UV-a照射方案以及提供更高水平的补充氧气以增强交联的能力。

If approved, the company anticipates Epioxa would be the first FDA-approved, non-invasive corneal cross-linking therapy that does not require removal of the corneal epithelium, the outermost layer of the front of the eye..

如果获得批准，该公司预计Epioxa将是FDA批准的第一种无创性角膜交联疗法，不需要去除角膜上皮（眼睛前部的最外层）。。

About Glaukos

劳科斯

Glaukos (www.glaukos.com) is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. Glaukos first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012.

Glaukos（www.Glaukos.com）是一家眼科制药和医疗技术公司，专注于开发和商业化治疗青光眼，角膜疾病和视网膜疾病的新型疗法。Glaukos首先开发了微创青光眼手术（MIGS），作为传统青光眼治疗范式的替代方案，并于2012年推出了其首款MIGS设备。

In 2024, Glaukos commenced commercial launch activities for iDose® TR, a first-of-its-kind, long-duration, intracameral procedural pharmaceutical designed to deliver 24/7 glaucoma drug therapy inside the eye for extended periods of time. Glaukos also markets the only FDA-approved corneal cross-linking therapy utilizing a proprietary bio-activated pharmaceutical for the treatment of keratoconus, a rare corneal disorder.

2024年，Glaukos开始了iDose®TR的商业启动活动，iDose®TR是同类产品中第一种持续时间长的前房内手术药物，旨在长时间提供24/7的眼内青光眼药物治疗。Glaukos还销售唯一一种FDA批准的角膜交联疗法，该疗法利用专有的生物活化药物治疗圆锥角膜，这是一种罕见的角膜疾病。

Glaukos continues to successfully develop and advance a robust pipeline of novel, dropless platform technologies designed to meaningfully advance the standard of care and improve outcomes for patients suffering from chronic eye diseases..

Glaukos继续成功开发和推进新型无滴平台技术的强大管道，旨在有意义地提高护理标准，改善慢性眼病患者的预后。。