当前位置：药品说明书与价格首页 >> 眼科 >> 新药动态 >> FDA批准新型眼用溶液Cequa用于治疗干燥性角膜结膜炎

FDA批准新型眼用溶液Cequa用于治疗干燥性角膜结膜炎

2018-09-12 03:17:40 作者：新特药房来源：互联网浏览次数：15 文字大小：【大】【中】【小】

简介： 首个环孢霉素A结合纳米胶束技术：Cequa(cyclosporine 环孢霉素眼用溶液,0.09%)-获美国FDA批准用于治疗干眼症 2018年8月17日，印度太阳制药公司（Sun Pharma）宣布，其眼科药物Cequa（cyclosporine 环孢霉 ...

关键字：环孢霉素眼用溶液 0.09% cyclosporine 商标名CEQUA 治疗干燥性角膜结膜炎

首个环孢霉素A结合纳米胶束技术：Cequa(cyclosporine 环孢霉素眼用溶液,0.09%)-获美国FDA批准用于治疗干眼症
2018年8月17日，印度太阳制药公司（Sun Pharma）宣布，其眼科药物Cequa（cyclosporine 环孢霉素眼用溶液，0.09%）已获美国食品和药物管理局（FDA）批准，用于干眼症患者的治疗。Cequa是环孢霉素A浓度为0.09%的新型专利纳米胶束配方，是一种不含防腐剂的清透水溶液，每日2次滴于眼部可增加泪液产品。
值得一提的是，Cequa是首个也是唯一一个结合了环孢霉素A和纳米胶束技术的干眼症治疗药物，可提供获FDA批准的最高浓度的环孢霉素A。这种创新性的纳米胶束配方允许环孢霉素A分子克服溶解度方面的挑战，穿透眼睛的水层，并能防止活性亲脂性分子在渗透之前释放。
Cequa获批是基于一项为期12周的多中心、随机、双盲、赋形剂对照III期验证性临床研究的数据。该研究入组了744例干眼症患者，研究中患者随机分配接受Cequa或其赋形剂治疗。
数据显示，经过12周的治疗，与赋形剂相比，Cequa在主要终点泪液分泌试验得分（泪液分泌的衡量指标）方面实现了统计学意义的显著改善（p＜0.01）。与其他同类干眼病治疗药物相比，Cequa在12周治疗过程中起效更早。此外，与赋形剂相比，Cequa在多个关键次要终点方面也表现出统计学意义的显著改善，其中有些次要终点（例如，眼部染色评估）甚至更早地（早至治疗1个月时）就表现出改善作用。
安全性方面，该研究中报告的不良事件大多轻微，Cequa治疗组最常见的不良反应为滴液部位疼痛（22%）和结膜充血（6%），其他不良反应（1%-5%）包括眼部刺激、睑缘炎、尿路感染、头痛和支气管炎。
干眼症又名角结膜干燥症，是指由任何原因（包括老龄、配戴隐形眼镜、某些药物、眼疾、其他疾病或环境因素等）造成的泪液质、量异常或动力学异常，导致泪膜稳定性下降（泪膜破坏并在角膜上形成干斑），并伴有眼部不适（眼睛干涩、刺痛、灼痛、砂砾感等）和/或眼表组织病变特征的多种疾病的总称，，主要治疗方法是使用人工泪液。据估计，在美国有多大1600万成年人被诊断患有干眼症。
环孢霉素A是一种免疫调节剂与抗炎药，能抑制促炎症细胞因子的生成与释放水平，并上升抗炎症细胞因子的释放水平，临床上可有效地改善由长期炎症所致的干眼症状与体征。环孢素A能以滴眼液的形式眼部给药，但由于其在水中的溶解度较低，因此常采用亲脂性载体提高药物的穿透力。艾尔建的Restasis（丽眼达，0.05%环孢霉素A）是2003年在美国上市的一种水包油阴离子型环孢霉素A乳剂，用于慢性、中至重度干眼的长期治疗，该药在2017年的销售额高达14.7亿美元。
Cequa采用了纳米胶束配方技术，胶束是两亲性（疏水性和亲水性）分子在特定的浓度下形成的胶状团聚体，能以一种澄清溶液的形式递送亲脂性分子环孢霉素A。同时，纳米胶束的小尺寸有利于进入角膜和结膜细胞，从而能够递送高浓度的环孢霉素A。
太阳制药北美公司首席执行官Abhay Gandhi表示，干眼症是一个医疗需求高度未满足的治疗领域，有相当多的患者目前未接受治疗。Cequa获得FDA批准，代表着一个备受期待的干眼症新治疗选择，同时也是太阳制药眼科事业发展的一个重要里程碑。
Cequa III期临床首席研究员Jodi Luchs表示，干眼症是一种复杂的疾病，缺乏一种“普适性（one-size-fits-all）”的治疗方法，并且我认为，干眼症最重要的是有多种治疗方式可供选择。鉴于强劲的临床研究表现，Cequa的获批非常令人激动，我期待着为我的患者提供这种令人信服的新治疗选择。
U.S. FDA Approval of CEQUA™ to Treat Dry Eye Disease
US Food and Drug Administration (FDA) has approved cyclosporine A ophthalmic solution 0.09% (Cequa, Sun Pharmaceuticals) to increase tear production in patients with keratoconjunctivitis sicca (dry eye), the company has announced.
Cequa is a patented, novel, proprietary nanomicellar formulation of cyclosporine A, 0.09% in a clear, preservative-free, aqueous solution.
Cequa was assessed in a phase 3 confirmatory study involving 744 patients with dry eye who were treated with Cequa or its vehicle. After 12 weeks of treatment, Cequa led to a statistically significant improvement in the primary endpoint, Schirmer's score (a measurement of tear production; P<.01) compared with vehicle.
Improvements in ocular staining assessments (secondary endpoints) were evident as early as 1 month after starting treatment. Cequa is dosed twice daily and will be available as a single-use vial, the company said.
In a prior phase 2b/3 clinical trial with 455 patients, Cequa demonstrated increased tear production (P<.01) and was well tolerated. Several key secondary endpoints also showed statistically significant improvements compared with vehicle.
The most common adverse reaction following the use of cyclosporine ophthalmic solution 0.09% was instillation site pain (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of the patients were eye irritation, blepharitis, urinary tract infection, headache, and bronchitis.
About CEQUA™
CEQUA(cyclosporine A, ophthalmic solution) is a patented, novel, proprietary nanomicellar formulation of cyclosporine A, 0.09% in a clear, preservative-free, aqueous solution. In a multicentered, randomized, double-masked, vehicle-controlled Phase 3 confirmatory study, 744 patients with dry eye were treated either with CEQUA or its vehicle. After 12 weeks of treatment, as compared to vehicle, CEQUA showed statistically significant improvement in the primary end point, Schirmer’s score (a measurement of tear production) (p<0.01). Additionally, several key secondary endpoints showed statistically significant improvements compared to vehicle, with some showing improvement as early as 1 month following treatment. Adverse events reported in the trial were mostly mild in nature. In a prior Phase 2b/3 clinical trial with 455 patients, CEQUA demonstrated increased tear production (p<0.01) and was well tolerated by the study population. Additionally, several key secondary endpoints showed statistically significant improvements compared to vehicle. The most common adverse reaction following the use of cyclosporine ophthalmic solution 0.09% was instillation site pain (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of the patients were eye irritation, blepharitis urinary tract infection, headache, and bronchitis.
INDICATIONS AND USAGE
CEQUA (cyclosporine ophthalmic solution) 0.09% is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye).
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Potential for Eye Injury and Contamination: To avoid the potential for eye injury and contamination, advise patients not to touch the vial tip to the eye or other surfaces.
Use with Contact Lenses: CEQUA should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of CEQUA ophthalmic solution.
ADVERSE REACTIONS
The most common adverse reactions reported in greater than 5% of patients were pain on instillation of drops (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of patients were blepharitis, eye irritation, headache, and urinary tract infection.