Wirta David L, Galor Anat, Aune Carol A, Vollmer Patrick M, Liang Eva, Meides Alice S, Krösser Sonja
Eye Research Foundation, Newport Beach, CA.
Miami Veterans Administration Medical Center and Bascom Palmer Eye Institute, University of Miami, Miami, FL.
Cornea. 2024 May 21;44(6):692-700. doi: 10.1097/ICO.0000000000003567.
The ESSENCE-2 Open-Label Extension study aimed to demonstrate long-term safety, tolerability, and efficacy of a novel water-free, nonpreserved topical cyclosporine 0.1% ophthalmic solution (US brand name VEVYE) for patients with dry eye disease (DED).
This was a Phase 3, prospective, multicenter, open-label, clinical study. All patients received cyclosporine 0.1% ophthalmic solution and dosed each eye twice a day for 52 weeks. Primary safety end points were ocular and nonocular adverse events (AEs). Secondary safety end points included visual acuity, biomicroscopy, intraocular pressure, and dilated fundoscopy. Efficacy end points, such as total corneal fluorescein staining (tCFS) score (National Eye Institute [NEI] Scale), ocular symptoms (visual analog scale [VAS]), and Schirmer tear test, were also assessed.
A total of 202 patients were enrolled from the ESSENCE-2 study. At week 52, 175 patients (86.6%) completed ESSENCE-2 open-label extension. A total of 55 patients (27.5%) reported 74 ocular treatment-emergent adverse events (TEAEs). The most common ocular AE was instillation site pain (6.5%), which was of mild intensity in all cases. Patients showed statistically significant improvements in all prespecified efficacy end points compared with baseline at each visit. Corneal staining improvements were early and stabilized over time while tear production improved continuously. Symptomatology improvement followed these effects with scores reaching a minimum after 1 year of treatment.
The water-free cyclosporine 0.1% ophthalmic solution was safe and well tolerated during long-term use. The results demonstrated sustained 1-year efficacy, in both signs and symptoms of DED, and may help understand short and long-term healing dynamics in a predominant inflammatory DED population.
ESSENCE - 2开放标签扩展研究旨在证明一种新型无水、无防腐剂的0.1%环孢素滴眼液（美国品牌名VEVYE）用于干眼症（DED）患者的长期安全性、耐受性和疗效。
这是一项3期、前瞻性、多中心、开放标签的临床研究。所有患者均接受0.1%环孢素滴眼液治疗，每只眼睛每天滴眼两次，持续52周。主要安全性终点为眼部和非眼部不良事件（AE）。次要安全性终点包括视力、生物显微镜检查、眼压和散瞳眼底检查。还评估了疗效终点，如总角膜荧光素染色（tCFS）评分（美国国立眼科研究所[NEI]量表）、眼部症状（视觉模拟量表[VAS]）和泪液分泌试验。
共有202例患者从ESSENCE - 2研究中入组。在第52周时，175例患者（86.6%）完成了ESSENCE - 2开放标签扩展研究。共有55例患者（27.5%）报告了74例眼部治疗中出现的不良事件（TEAE）。最常见的眼部AE是滴眼部位疼痛（6.5%），所有病例均为轻度。与每次访视时的基线相比，患者在所有预先设定的疗效终点上均有统计学意义的改善。角膜染色改善出现较早且随时间稳定，而泪液分泌持续改善。症状改善在这些效果之后出现，治疗1年后评分达到最低。
长期使用无水0.1%环孢素滴眼液是安全且耐受性良好的。结果表明，在DED的体征和症状方面均有持续1年的疗效，并且可能有助于了解以炎症为主的DED人群的短期和长期愈合动态。
