Pieramici Dante J, Avery Robert L
The California Retina Consultants and Research Foundation, 515 East Micheltorena St, Suite C, Santa Barbara, California 93103, USA.
Expert Opin Biol Ther. 2006 Nov;6(11):1237-45. doi: 10.1517/14712598.6.11.1237.
Vascular endothelial growth factor (VEGF)-A is a major regulator of angiogenesis and vascular permeability implicated in the development of diseases involving pathological angiogenesis and increased vascular permeability, such as neovascular age-related macular degeneration (AMD). LUCENTIS (ranibizumab), a humanized antigen-binding fragment (Fab) that neutralizes all VEGF-A isoforms and their biologically active degradation products, was recently approved by the FDA. Ranibizumab is the first FDA-approved treatment for neovascular AMD that maintains or improves vision in > or = 90% patients and provides a > or = 15-letter improvement in visual acuity for a quarter to a third of patients with all choroidal neovascularisation subtypes. Ranibizumab was associated with a < or = 1.7% rate of key serious ocular adverse events, such as endophthalmitis and uveitis, in two pivotal Phase III trials.
血管内皮生长因子(VEGF)-A是血管生成和血管通透性的主要调节因子,与涉及病理性血管生成和血管通透性增加的疾病发展有关,如新生血管性年龄相关性黄斑变性(AMD)。雷珠单抗(LUCENTIS)是一种人源化抗原结合片段(Fab),可中和所有VEGF-A异构体及其生物活性降解产物,最近获得了美国食品药品监督管理局(FDA)的批准。雷珠单抗是FDA批准的首个用于治疗新生血管性AMD的药物,在≥90%的患者中可维持或改善视力,并且对于所有脉络膜新生血管亚型的患者,四分之一至三分之一的患者视力可提高≥15个字母。在两项关键的III期试验中,雷珠单抗导致严重眼部不良事件(如眼内炎和葡萄膜炎)的发生率≤1.7%。