DEVELOPMENT OF RANIBIZUMAB, AN ANTI–VASCULAR ENDOTHELIAL GROWTH FACTOR ANTIGEN BINDING FRAGMENT, AS THERAPY FOR NEOVASCULAR AGE-RELATED MACULAR DEGENERATION

The safety and efficacy of ranibizumab in the treatment of neovascular AMD have been evaluated in two large phase III, multicenter, randomized, double-masked, controlled pivotal trials in different neovascular AMD patient populations. Combined, the trial results indicate that ranibizumab results not only in a slowing down of vision loss but also in a significant proportion of patients experiencing a clinically meaningful vision gain. The visual acuity benefit over control was observed regardless of CNV lesion type. Furthermore, the benefit was associated with a low rate of serious adverse events.

Ranibizumab represents a novel therapy that, for the first time, appears to have the potential to enable many AMD patients to obtain a meaningful and sustained gain of vision. On June 30 2006, ranibizumab was approved by the US Food and Drug Administration for the treatment of wet AMD. Vascular endothelial growth factor (VEGF)-A is a major mediator of angiogenesis and microvascular permeability. The article described the preclinical and clinical development of ranibizumab, an anti-VEGF-A antigen binding fragment, which was approved by the US Food and Drug Administration for the treatment of the wet form of age-related macular degeneration in June 2006. Administration of ranibizumab resulted in a meaningful and sustained vision gain in a significant proportion of AMD patients.