Harrow Announces Promising 52-Week Data from Vevye ESSENCE-2 Clinical Study

哈罗公布了Vevye ESSENCE-2临床研究52周的数据

June 06, 2024

2024年6月6日

Harrow, a leading pharmaceutical company, has revealed the encouraging results from its ESSENCE‑2 open-label extension (OLE) clinical study for Vevye (cyclosporine ophthalmic solution) 0.1%, a novel treatment for dry eye disease (DED).

领先的制药公司哈罗（Harrow）公布了其ESSENCE-2开放标签扩展（OLE）临床研究的令人鼓舞的结果，该研究针对0.1%的Vevye（环孢素眼用溶液），这是一种治疗干眼症（DED）的新型疗法。

Study Design and Outcomes: ESSENCE-2 OLE Analysis

研究设计和结果：Essential-2 OLE分析

The ESSENCE-2 OLE study, a phase 3, prospective, multicenter, open-label clinical trial involving 202 patients who had previously completed the ESSENCE‑2 study, evaluated the efficacy and safety of Vevye administered twice daily for 52 weeks. Published in Cornea, the 1-year study demonstrated the sustained effectiveness and safety of Vevye in managing the signs and symptoms of DED.

Essential-2 OLE研究是一项3期前瞻性多中心开放标签临床试验，涉及202名先前完成Essential-2研究的患者，评估了Vevye的疗效和安全性，每天两次，持续52周。这项为期1年的研究发表在《角膜》杂志上，证明了Vevye在管理DED症状和体征方面的持续有效性和安全性。

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Key findings include:

主要调查结果包括：

● Statistically significant enhancements in all prespecified efficacy endpoints compared to baseline at each visit.

● 与每次就诊时的基线相比，所有预先设定的疗效终点均有统计学意义上的显着增强。

● Early improvements in corneal staining, which stabilized over time, accompanied by continuous enhancement in tear production and subsequent symptom relief.

● 角膜染色的早期改善随着时间的推移而稳定，伴随着泪液产生的持续增强和随后的症状缓解。

● The most frequent ocular treatment-related adverse events were mild instillation site pain in 13 patients (6.5%) and reduced visual acuity in 6 patients (3.0%). Only one patient withdrew from the 52-week study due to an ocular adverse event (mild burning/stinging).

● 最常见的眼部治疗相关不良事件是13例患者（6.5%）的轻度滴注部位疼痛和6例患者（3.0%）的视力下降。由于眼部不良事件（轻度灼伤/刺痛），只有一名患者退出了为期52周的研究。

● When asked to rate their satisfaction with the study eye drop on a scale of 0 to 10, with 10 being the highest rating, 33.1% of patients gave the highest possible rating of 10. Approximately 91% of patients rated a score of 5 or higher, indicating satisfaction with the treatment.

● 当被要求对他们对研究滴眼液的满意度进行0到10的评分时，其中10分是最高评分，33.1%的患者给出了最高可能的评分10分。大约91%的患者评分为5分或更高，表明对治疗的满意度。

● Investigators concluded that water-free cyclosporine 0.1% ophthalmic solution was safe and well tolerated during long-term use.

● 研究人员得出结论，无水环孢素0.1%眼用溶液在长期使用期间安全且耐受性良好。

Expert Insights: Dr. Laura M. Periman's Commentary

专家见解：劳拉·M·佩里曼博士的评论

Commenting on the study findings, Dr. Laura M. Periman, ophthalmologist and Director of Dry Eye Services and Clinical Research at Periman Eye Institute, emphasized the significance of the results in addressing patient tolerability and treatment compliance. 'In this 52-week study, perhaps the most impressive data point was that only one patient stopped using Vevye because of an ocular adverse event, which was mild burning and stinging,' Dr.

佩里曼眼科研究所眼科医生兼干眼症服务和临床研究主任劳拉·佩里曼博士在评论研究结果时强调了研究结果在解决患者耐受性和治疗依从性方面的重要性。”在这项为期52周的研究中，最令人印象深刻的数据点可能是，只有一名患者因眼部不良事件停止使用Vevye，这是轻微的灼烧和刺痛。

Periman remarked in a company news release. 'ESSENCE-2 OLE data demonstrates the long-term potential of Vevye for patients suffering from chronic dry eye disease.'.

佩里曼在公司新闻稿中表示ESSENCE-2 OLE数据证明了Vevye对患有慢性干眼症的患者的长期潜力。”。

The study's outcomes underscore the promising role of Vevye in providing long-term relief to individuals grappling with the burdensome effects of chronic dry eye disease, offering hope for improved patient outcomes and treatment adherence.

这项研究的结果强调了Vevye在长期缓解慢性干眼症的沉重影响方面的有希望的作用，为改善患者预后和治疗依从性提供了希望。