2012年10月17日美国食品药品监督管理局(FDA)批准Jetrea(ocriplasmin)，第一个被批准治疗一种眼情况被称为症状性玻璃体黄斑粘连(VMA)。 玻璃体黄斑粘连可能对眼问题有贡献，如玻璃体(眼中果冻样物质)开始离开黄斑(视网膜负责阅读视力的部分)。这种运动由于拉或拽黄斑可导致黄斑损伤。 Jetrea是一种酶分解负责眼中玻璃体黄斑粘连的蛋白质。这些蛋白的分解玻璃体和黄斑间更好分离和可减少拉扯将出现的机会。这种情况的另外治疗是一种手术被称为玻璃体切除术. FDA的药品评价和研究中心抗微生物产品室主任Edward Cox，M.D.，M.P.H.说“今天的批准代表一个对患症状性玻璃体黄斑粘连患者治疗重要进展，”“那些有这种视力威胁的疾病患者现有一种非手术治疗选择。” 在两项临床研究涉及652例症状性玻璃体黄斑粘连患者中确定Jetrea的安全性和有效性。患者被随机赋予接受单次注射Jetrea至眼或一种无活性成分物质。 经历下一个28天患者被评价和对经历下6个月任何副作用。 研究发现玻璃体黄斑粘连用Jetrea治疗患者解决26 %与之比较用无活性产品治疗患者为10 %。 用Jetrea治疗患者中最常报道副作用包括眼飞蚊症；结膜出血，眼睑内侧衬里组织和覆盖眼白部分；眼痛；闪烁光(闪光)；视力模糊；视力不清；视力丧失；视网膜水肿(肿胀)；和黄斑水肿。. Jetrea由Iselin制造，位于N.J ThromboGenics Inc公司。 JETREA® (ocriplasmin)玻璃体注射，2.5mg/mL 美国初次批准：2012 适应症和用途 JETREA是一种蛋白水解酶适用于症状性玻璃体黄斑粘连的治疗。 剂量和给药方法 （1）用前必须稀释。 （2）只为单次眼玻璃体注射使用。 （3）推荐剂量为0.125mg(0.1mL稀释溶液)通过玻璃体注射给予受影响眼单剂量1次。 剂型和规格 单次使用玻璃小瓶含JETREA 0.5mg在0.2mL溶液中为玻璃体注射(2.5mg/mL)。 禁忌症 无。 警告和注意事项 （1）由于可能发生进展条件牵引视力减低需要手术干预。应监视患者和教导不延缓地报告任何症状。 （2）玻璃体注射后可能发生玻璃体内注射操作伴效应(眼内炎症/感染，眼内出血和眼内压增加)。应监视患者和教导不延缓地报告任何症状。 （3）晶状体半脱位的潜力。 不良反应 用Jetrea治疗患者中最常报道反应(≥ 5%)是玻璃体飞蚊症，结膜出血，眼痛，闪光，视力模糊，黄斑孔，视力下降，视力受损，和视网膜水肿。 Jetrea: first pharmacological treatment for vitreomacular adhesion Jetrea (ocriplasmin) is an intravitreal injection for the treatment of vitreomacular traction (VMT), including that associated with macular holes of up to 400 microns diameter. PHARMACOLOGY Ocriplasmin is a truncated form of human plasmin. It has a proteolytic effect on numerous components of the vitreous body and vitreoretinal interface, including collagen, fibronectin and laminin. It is the abnormal binding of these proteins that can result in vitreomacular adhesion (VMA), leading to VMT. 1 CLINICAL STUDIES The safety and efficacy of ocriplasmin was evaluated in two multicentre, randomised, double-blind, phase III studies involving 652 adults with VMT. In an analysis of the combined results, the incidence of VMA resolution at day 28 was significantly higher in patients treated with ocriplasmin than in those given placebo (26.5% vs 10.1%, p<0.001).2 With regard to secondary endpoints, total posterior vitreous detachment at day 28 was more common in the ocriplasmin group than in the placebo group (13.4% vs. 3.7%, p<0.001). Non-surgical closure of macular holes was achieved in 40.6% of ocriplasmin-injected eyes, compared with 10.6% of placebo-injected eyes (p<0.001).2 -------------------------------------------------- JETREA® (ocriplasmin) Intravitreal Injection, 2.5 mg/mL, is a proteolytic enzyme indicated for the treatment of symptomatic vitreomacular adhesion. Important Safety Information Warnings and Precautions ■A decrease of ≥ 3 lines of best-corrected visual acuity (BCVA) was experienced by 5.6% of patients treated with JETREA and 3.2% of patients treated with vehicle in the controlled trials. The majority of these decreases in vision were due to progression of the condition with traction and many required surgical intervention. Patients should be monitored appropriately. ■Intravitreal injections are associated with intraocular inflammation/infection, intraocular hemorrhage and increased intraocular pressure (IOP). Patients should be monitored and instructed to report any symptoms without delay. In the controlled trials, intraocular inflammation occurred in 7.1% of patients injected with JETREA vs 3.7% of patients injected with vehicle. Most of the post-injection intraocular inflammation events were mild and transient. If the contralateral eye requires treatment with JETREA, it is not recommended within 7 days of the initial injection in order to monitor the post-injection course in the injected eye. ■Potential for lens subluxation. ■In the controlled trials, the incidence of retinal detachment was 0.9% in the JETREA group and 1.6% in the vehicle group, while the incidence of retinal tear (without detachment) was 1.1% in the JETREA group and 2.7% in the vehicle group. Most of these events occurred during or after vitrectomy in both groups. ■Dyschromatopsia (generally described as yellowish vision) was reported in 2% of all patients injected with JETREA. In approximately half of these dyschromatopsia cases there were also electroretinographic (ERG) changes reported (a- and b-wave amplitude decrease). Adverse Reactions ■The most commonly reported reactions (≥ 5%) in patients treated with JETREA were vitreous floaters, conjunctival hemorrhage, eye pain, photopsia, blurred vision, macular hole, reduced visual acuity, visual impairment, and retinal edema. Jetrea是欧盟首个推荐用于治疗玻璃体黄斑牵引综合征的药物 欧洲药品管理局（EMA）人用药品委员会（CHMP）推荐批准用于治疗玻璃体黄斑牵引综合征（VMT）的首个药物Jetrea上市。 玻璃体液随年龄增长而出现皱缩，进而导致黄斑牵拉，后者可引起视力降低和成像变性，并且是黄斑裂孔形成的危险因素之一。目前唯一可选的VMT有效疗法为移除玻璃体液的玻璃体切割术。然而，玻璃体切割术后患者将有4至6周无法正常工作和生活，并且需在1至2周内采用极为不便的俯卧位。 近日，欧洲药品管理局（EMA）人用药品委员会（CHMP）推荐批准用于治疗玻璃体黄斑牵引综合征（VMT）的首个药物Jetrea上市。 Jetrea含有新型活性物质重组人蛋白奥克纤溶酶（ocriplasmin）。Ocriplasmin对玻璃体液和视网膜交界面的蛋白具有酶活性。通过降解上述蛋白，Ocriplasmin可松解玻璃体液与黄斑之间的粘连，进而消除黄斑牵引。CHMP推荐批准Jetrea用于治疗VMT，其中包括直径≤400μm的相关性黄斑裂孔。推荐剂量为患目单剂量125mg玻璃体内注射。CHMP同时要求生产商向计划应用Jetrea的医务人员提供相关信息。 美国食品与药物管理局（FDA）也于2012年10月批准了Jetrea用于治疗症状性玻璃体黄斑黏连（VWA）。 -------------------------------------------------- 产地国家: 美国 原产地英文商品名: JETREA 0.5MG/0.2ML SINGLE USE VIAL 原产地英文药品名: OCRIPLASMIN 中文参考商品译名: JETREA玻璃体注射剂 0.5毫克 0.2毫升 中文参考药品译名: OCRIPLASMIN 生产厂家中文参考译名: THROMBOGENICS, INC 生产厂家英文名: THROMBOGENICS, INC