雷珠单抗获准用于治疗糖尿病黄斑水肿

美国食品药品管理局(FDA)已批准将雷珠单抗用于治疗糖尿病黄斑水肿(DME)。

根据FDA的统计，2010年约有400万成人糖尿病患者报告有视力问题。DME是一种危及视力的眼科疾病，好发于糖尿病患者，并可能导致失明。

雷珠单抗注射剂(或称Lucentis)是首个被批准用于治疗DME的药物，用法为每次0.3 mg，每月使用1次，并且必须由医务人员进行注射。目前对这一疾病的标准治疗为病灶激光治疗。Lucentis是由基因泰克公司生产的，之前已被批准用于治疗新生血管性年龄相关性黄斑变性和视网膜静脉阻塞后的黄斑水肿。

FDA药物评估与研究中心移植与眼科产品部门主管Renata Albrecht博士在声明中说：“Lucentis通过审批意味着对糖尿病并发DME并导致视力受损患者的治疗取得了一大进步。”基因泰克公司首席医学官兼全球产品研发部门主管Hal Barron博士在声明中指出：“我们非常荣幸地获得了Lucentis在美国的第三个适应证许可，视力受到糖尿病影响的新的患者群将从Lucentis治疗中获益。”

该药通过审批是基于包含759例接受治疗和3年随访患者的两项临床研究的结果。 研究结果显示，在每月接受Lucentis 0.3 mg 治疗的患者中，34%~45%的视力提高了至少3行，而在未接受药物注射的患者中，仅有12%~18%的视力提高了至少3行。更高的测试剂量0.5 mg未显示进一步收益。该药物最常见的不良反应为结膜出血。

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By: NASEEM S. MILLER, Clinical Endocrinology News Digital Network

The Food and Drug Administration has approved ranibizumab for treatment of diabetic macular edema.

Ranibizumab injection, or Lucentis, is the first approved drug treatment of diabetic macular edema (DME) to be administered at a dosage of 0.3 mg once a month by a health care professional. The standard therapy for the condition thus far has been focal laser treatment.
 
"Today’s approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease," said Dr. Renata Albrecht, director of the division of transplant and ophthalmology products in FDA’s Center for Drug Evaluation and Research, in a statement.

Lucentis, developed by Genentech, was previously approved for treatment of neovascular age-related macular degeneration and for macular edema following retinal vein occlusion.

"We developed Lucentis to treat diseases of the eye and are pleased to have received this third U.S. indication to help a new population of people whose eyesight may be affected by diabetes," said Dr. Hal Barron, chief medical officer and head of global product development for Genentech, in a statement.

Roughly 4 million adults with diabetes reporter vision problems in 2010, according to the FDA.

The drug’s approval is based on the results of two clinical studies including 759 patients who were treated and followed for 3 years.

Results showed that 34%-45% of the patients who were treated monthly with 0.3 mg of Lucentis, gained at least three lines of vision compared with 12%-18% of those who didn’t receive the injection, according to the FDA. The higher tested dose of 0.5 mg showed no additional benefit.

The most common side effects of the drug are bleeding of the conjunctiva.

DME is a sight-threatening eye disease, in which fluid leaks to the macula and causes blurred vision. The condition affects people with diabetes and can lead to blindness.

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