新型玻璃体内植入剂Ozurdex(Dexamethasone)获FDA批准用于治疗视网膜中央静脉和分支静脉阻塞。 近日，美国食品药物管理局(FDA)已批准地塞米松玻璃体内植入剂dexamethasoneOzurdex（商标名：OZURDEX 0.7mg）用于治疗视网膜分支静脉阻塞(BRVO)或视网膜中央静脉阻塞 (CRVO) 后黄斑水肿。根据Allergan公司提供的数据，视网膜静脉阻塞，包括BRVO和CRVO，是继糖尿病视网膜病变之后第2大常见的视网膜血管病变，是视力下降的重要原因。 Ozurdex是一种可生物降解的植入剂，它被放置于眼睛后段的玻璃体腔内。该药通过玻璃体内注射。通过Allergan公司被称为Novadur的专有固体聚合物释放系统释放地塞米松注射液。 批准日期：2009年6月18日  公司：Allergan公司 OZURDEX（地塞米松[dexamethasone]）内植入物，用于玻璃体内注射 最初的美国批准：1958年 最近的主要变化 适应症和用法：9/2014 禁忌症：9/2014 警告和注意事项：9/2014 作用机制 已显示地塞米松是一种皮质类固醇，通过抑制多种炎性细胞因子来抑制炎症，导致水肿，纤维蛋白沉积减少，毛细血管渗漏和炎性细胞迁移。 适应症和用法 OZURDEX®是一种皮质类固醇，适用于： 视网膜分支静脉阻塞（BRVO）或视网膜中央静脉阻塞（CRVO）后黄斑水肿的治疗。 治疗影响眼后节的非感染性葡萄膜炎 糖尿病性黄斑水肿的治疗。 剂量和给药 用于眼科玻璃体内注射。 玻璃体内注射过程应在受控无菌条件下进行。 玻璃体内注射后，应监测患者眼内压升高和眼内炎。 剂型和强度 在NOVADUR®固体聚合物药物输送系统中含有0.7mg地塞米松的玻璃体内植入物。 禁忌症 眼或眼周感染 青光眼 撕裂或破裂的晶状体后囊 过敏症 警告和注意事项 玻璃体内注射与眼内炎，眼睛炎症，眼内压升高和视网膜脱离有关。注射后应监测患者。 使用皮质类固醇可能会导致后囊下白内障，眼内压升高，青光眼，并可能增加由细菌，真菌或病毒引起的继发性眼部感染。 不良反应 在对照研究中，20-70％的患者报告的最常见的不良反应是白内障，眼内压升高和结膜出血。 包装提供/储存和处理 OZURDEX®（地塞米松玻璃体内植入物）0.7mg以1个一次性塑料涂药器NDC 0023-3348-07提供在箔袋中。 储存：储存于15°-30°C（59°-86°F）。 美国包装 OZURDEX IMPLANT 0.7MG KIT DPSH 1/EA  DEXAMETHASONE INTRAVITREAL "ALLERGAN SALES, LLC"  00023-3348-07             OZURDEX INTRAVITR IMPLANT D/S DEXAMETHASONE  ALLERGAN PHARMACEUTICAL  00023-3348-07 完整治疗资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4b204f44-6e8a-4d17-803c-268f0b04679f Ozurdex(Dexamethasone Intravitreal Implant) OZURDEX® (dexamethasone intravitreal implant) is a prescription medicine that is an implant injected into the eye (vitreous) and used: To treat adults with diabetic macular edema To treat adults with swelling of the macula (macular edema) following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) To treat adults with noninfectious inflammation of the uvea (uveitis) affecting the back segment of the eye IMPORTANT SAFETY INFORMATION (continued) When Not to Use OZURDEX® (continued) OZURDEX® should not be used if you have glaucoma that has progressed to a cup-to-disc ratio of greater than 0.8. OZURDEX® should not be used if you have a posterior lens capsule that is torn or ruptured. OZURDEX® should not be used if you are allergic to any of its ingredients. Warnings and Precautions Injections into the vitreous in the eye, including those with OZURDEX®, are associated with serious eye infection (endophthalmitis), eye inflammation, increased eye pressure, and retinal detachments. Your eye doctor should monitor you regularly after the injection. Use of corticosteroids including OZURDEX® may produce posterior subcapsular cataracts, increased eye pressure, glaucoma, and may increase the establishment of secondary eye infections due to bacteria, fungi, or viruses. Let your doctor know if you have a history of ocular herpes simplex as corticosteroids are not recommended in these patients. Common Side Effects in Diabetic Macular Edema The most common side effects reported in patients with diabetic macular edema include: cataract, increased eye pressure, conjunctival blood spot, reduced vision, inflammation of the conjunctiva, specks that float in the field of vision, swelling of the conjunctiva, dry eye, vitreous detachment, vitreous opacities, retinal aneurysm, foreign body sensation, corneal erosion, inflammation of the cornea, anterior chamber inflammation, retinal tear, drooping eyelid, high blood pressure, and bronchitis. Common Side Effects in Retinal Vein Occlusion and Uveitis The most common side effects reported in patients for retinal vein occlusion and uveitis include: increased eye pressure, conjunctival blood spot, eye pain, eye redness, ocular hypertension, cataract, vitreous detachment, and headache. Patient Counseling Information After repeated injections with OZURDEX®, a cataract may occur. If this occurs, your vision will decrease and you will need an operation to remove the cataract and restore your vision.You may develop increased eye pressure with OZURDEX® that will need to be managed with eye drops, and rarely, with surgery. In the days following injection with OZURDEX®, you may be at risk for potential complications including in particular, but not limited to, the development of serious eye infection or increased eye pressure. If your eye becomes red, sensitive to light, painful, or develops a change in vision, you should seek immediate care from your eye doctor. You may experience temporary visual blurring after receiving an injection and should not drive or use machinery until your vision has resolved.