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Macugen (Pegaptanib Sodium), a Novel Ocular Therapeutic That Targets Vascular Endothelial Growth Factor (VEGF)

The development of Macugen (pegaptanib sodium), a pegylated antivascular endothelial growth factor (VEGF) RNA aptamer, represents an exciting new chapter in the management of ocular neovascular disease in that this novel therapeutic targets a key step in the pathogenesis of ocular neovascularization. Based on 2 prospective, multicenter, randomized, controlled, phase 3 trials collectively known as the VEGF Inhibition Study in Ocular Neovascularization (V.I.S.I.O.N) trials, pegaptanib was the first ophthalmic antiangiogenic agent approved for the treatment of all angiographic subtypes of neovascular age-related macular degeneration (AMD). In addition, recent studies show promise for pegaptanib in the treatment of diabetic macular edema (DME) and macular edema secondary to central retinal vein occlusion (CRVO). Historically, therapies for ocular neovascular diseases have largely been ineffective, although the advent of photocoagulation and photodynamic therapy (PDT) with verteporfin provided limited options for some subsets of patients. Unlike pegaptanib, however, these destructive therapies do not address the underlying pathology of these diseases. This article will provide a brief overview of the pathogenesis of ocular neovascularization, with particular emphasis on the prominent contribution of VEGF165, and the rationale for targeting this presumed pathogenic isoform in contrast to approaches that provide nonselective isoform blockade and its possible additional safety concerns. The preclinical and clinical studies supporting the efficacy and safety of pegaptanib will then be discussed.