ST LOUIS (MD Consult) - On June 22, 2010, Genentech announced that the US Food and Drug Administration (FDA) has approved Lucentis (ranibizumab) for the treatment of macular edema that can occur after retinal vein occlusion (RVO). Lucentis is a vascular endothelial growth-factor inhibitor (VEGF) that was first approved by the FDA in 2006 for the treatment of neovascular age-related macular degeneration.
Lucentis is designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in angiogenesis and the hyperpermeability of blood vessels. In RVO, angiogenesis and hyperpermeability can lead to macular edema, with the macula being the portion of the eye responsible for fine, detailed, central vision. According to Hal Barron, MD, executive vice president of global development and chief medical officer of Genentech, "In the Lucentis RVO clinical trials, significantly more people treated with monthly Lucentis showed sustained vision improvement during the 6-month study with an effect seen as early as seven days."
Lucentis is administered by intraocular injection. Treatment with Lucentis has been associated with retinal detachment and serious eye infections and should not be used in patients who are experiencing an infection in or around the eye. Increases in eye pressure have been seen within 1 hour of an injection. Although uncommon, conditions associated with eye- and non-eye-related arterial thromboembolic events may occur. Serious adverse effects include inflammation inside the eye and, rarely, effects related to the injection procedure (eg, cataract).
The most common non-eye-related adverse effects associated with the use of Lucentis include nasal and pharyngeal infections, headache, and respiratory and urinary tract infections. The most common eye-related untoward effects are a perception of foreign body in the eye and increased tear production. Patients should be instructed to seek immediate ophthalmologic care if they experience redness, light sensitivity, visual changes, or pain in the eye after treatment with Lucentis.
圣路易斯(MD Consult)——2010年6月22日，基因泰克宣布，美国食品药品管理局(FDA)已批准Lucentis(兰尼单抗)用于治疗可继发于视网膜静脉阻塞(RVO)的黄斑水肿。Lucentis是一种血管内皮生长因子(VEGF)抑制剂，于2006年首次获准用于治疗新生血管性老年黄斑变性。
Lucentis可结合并抑制VEGF-A，VEGF-A被认为是一种在血管新生过程及血管高渗性中起关键作用的蛋白。在RVO中，血管新生和高渗性可导致黄斑水肿，而黄斑是形成精细的中央视力的部位。据基因泰克公司全球发展执行副主席兼首席医学官Hal Barron博士称，“在有关Lucentis 的RVO临床试验中，接受每月1次Lucentis治疗者中6个月研究期内视力获得持续改善的患者例数明显增加，早在7天即可显效。”
Lucentis 经眼内注射用药。Lucentis治疗一直与视网膜剥脱及严重眼部感染有关，不宜用于眼内或眼周存在感染的患者。注射后1 h内可观察到眼压增加。眼部和非眼部相关的动脉血栓事件尽管不多见，但也可能会发生。严重不良反应包括眼内炎症，在极少数情况下，还可发生与注射过程相关的不良反应(如白内障)。
与使用Lucentis有关的最常见的非眼部不良反应包括鼻咽部感染、头痛以及呼吸道和泌尿道感染。最常见的眼部不良反应为眼部异物感 和泪液分泌过多。应指导患者在使用Lucentis治疗后出现发红、光敏感、视力改变或眼部疼痛时立即前去眼科就诊。
