近日，美国FDA批准艾尔建公司的0.7mg Ozurdex（地塞米松玻璃体腔植入物）可用于人工晶体眼或拟行白内障手术的成年人糖尿病黄斑水肿。
  Ozurdex为一种可以缓释、生物可降解的植入物，可以通过长期缓慢释放激素来抑制炎症，从而达到治疗糖尿病黄斑水肿的目的。据艾尔建发言称：Ozurdex长期有效，不需要每月注射。
  该植入物此前已经用于视网膜分支静脉阻塞、视网膜中央静脉阻塞引起的黄斑水肿及累及眼后节的非感染性葡萄膜炎的治疗。
  Ozurdex的新指征为：人工晶体眼或拟行白内障手术的成年人糖尿病黄斑水肿。
  FDA的批准Ozurdex的新用药指征基于长达3年的2项多中心、随机、空白对照、盲法临床试验，试验结果显示，与基线对照：植入物可增加15个字母或更大改善最佳矫正视力患者所占比例。
  研究中最常见的不良事件包括白内障及眼压升高。在每个治疗周期都可观察到平均眼压的升高，但是在每个治疗间期其均会回到基线水平。
  其它糖尿病黄斑水肿治疗中的不良效应包括：结膜点状出血、视力下降、结膜肿胀/炎症、黑影飘动、干眼、玻璃体脱离、玻璃体混浊、视网膜动脉瘤、异物感、角膜擦伤、角膜炎症、前房炎症、视网膜裂伤、上睑下垂、高血压。

Ozurdex(Dexamethasone Intravitreal Implant)
OZURDEX Rx
Generic Name and Formulations:
Dexamethasone 0.7mg in the Novadur delivery system; intravitreal implant; preservative-free.
Company:
Allergan
Select therapeutic use: Miscellaneous ocular agents
Indications for OZURDEX:
Macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Non-infectious uveitis affecting the posterior segment of the eye. Diabetic macular edema.
Adult:
For ophthalmic intravitreal injection only. One implant in each affected eye(s).
Children:
Not established.
Contraindications:
Ocular or periocular infections. Glaucoma (cup to disc ratio >0.8). Torn or ruptured posterior lens capsule.
Warnings/Precautions:
Monitor for intravitreal injection-related effects (eg, endophthalmitis, eye inflammation, increased intraocular pressure, retinal detachments) following the injection. Risk of potential steroid-related effects (eg, posterior subcapsular cataracts, glaucoma, secondary ocular infections). History of ocular herpes simplex: not recommended. Risk of implant migration to anterior chamber if posterior lens capsule is not intact. Pregnancy (Cat.C). Nursing mothers.
Pharmacological Class:
Corticosteroid.
Adverse Reactions:
Increased intraocular pressure, conjunctival hemorrhage, eye pain, conjunctival hyperemia, ocular hypertension, cataracts.
How Supplied:
Single-use intravitreal implant—1 (w. applicator)
完整治疗资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4b204f44-6e8a-4d17-803c-268f0b04679f