美国食品和药物管理局(FDA)已批准兰尼单抗(Ranibizumab，商品名lucentis)注射液(0.3 mg)适应证范围用于治疗糖尿病黄斑水肿患者的糖尿病视网膜病变。
FDA的药物评价和研究中心抗菌产品办公室主任Edward Cox， M.D.MPH.说“糖尿病是美国重大的公共卫生问题，每年影响到更多患者。今天的批准使糖尿病黄斑水肿患者的糖尿病视网膜病变患者获得治疗这视觉损害并发症的首个显着疗法。”
FDA称，兰尼单抗的安全性和有效性是基于涉及759例患者的，随访三年的两项临床研究，研究头24个月期间患者被随机赋予接受每月Lucentis注射0.3 mg或0.5 mg，或无注射。在24个月后，所有患者每个月接收Lucentis或 0.3 mg或0.5 mg.。研究表明，在治疗2年后，雷珠单抗治疗组患者症状得到显着改善。
兰尼单抗最常见的副作用包括结膜出血，眼痛，飞蚊症，眼内压增加。严重的副作用包括眼内炎和视网膜脱离。
FDA的先前之前已批准兰尼单抗治疗继发于视网膜静脉阻塞的DME和黄斑水肿，这两者均会引起液体渗漏到黄斑，从而导致视力模糊
在美国，兰尼单抗也被批准用于新生血管年龄相关性黄斑变性的治疗。兰尼单抗由玻璃体内注射给药，每月注射一次。
FDA称，糖尿病性视网膜病变是最常见的糖尿病眼病，是美国成年人失明的主要原因。（晓兰）
原文链接： http://www.medscape.com/viewarticle/839430
FDA clears Ranibizumab for Diabetic Retinopathy With DME
The US Food and Drug Administration (FDA) has expanded the approved use of ranibizumab (Lucentis， Genentech， Inc) injection (0.3 mg) to treat diabetic retinopathy in patients with diabetic macular edema (DME).
"Diabetes is a serious public health crisis， affecting more patients every year，" Edward Cox， MD， MPH， director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research， said in a news release. "Today's approval gives patients with diabetic retinopathy and diabetic macular edema the first significant therapy to treat this vision-impairing complication."
The safety and efficacy of ranibizumab to treat diabetic retinopathy with DME were established in two clinical studies involving 759 participants who were treated and followed for three years. In the two studies， treatment with ranibizumab led to significant improvement in severity of diabetic retinopathy at two years compared with that in patients who did not receive the drug， the FDA says.
The most common side effects include bleeding of the conjunctiva， eye pain， floaters， and increased intraocular pressure. Serious side effects include endophthalmitis and retinal detachment.
The FDA granted ranibizumab for diabetic retinopathy with DME breakthrough therapy designation and reviewed this new use for the drug under the agency's priority review program， which provides for an expedited review of drugs that demonstrate the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition.
The FDA previously had approved ranibizumab to treat DME and macular edema secondary to retinal vein occlusions， both of which cause fluid to leak into the macula， which can result in blurred vision.
Ranibizumab is also approved in the United States for the treatment of neovascular (wet) age-related macular degeneration. Ranibizumab is administered by intravitreal injection once monthly.
Diabetic retinopathy is the most common diabetic eye disease and is a leading cause of blindness in adults in the US， the FDA says.