Anti-Vascular Endothelial Growth Factor for Treating Diabetic Macular Edema and Diabetic Retinopathy: A Summary of Pivotal Trials and Studies

Abstract

Abstract This review summarizes clinical trials involving the use of anti-vascular endothelial growth factor (VEGF) that provided the evidence for therapy and paved the way for a new era in treating diabetic macular edema (DME). In 2006, ranibizumab was approved by the United States Food and Drug Administration (FDA), first for treating neovascular age-related macular degeneration (AMD) and then for treating other retinal diseases, including DME. This resulted in outcomes superior to those of retinal laser photocoagulation, the standard of care at that time. These improved outcomes led to a paradigm shift in the management of DME. Over the years, retina physicians and ophthalmologists have witnessed the development of new pharmacological molecules, whose ultimate aim is to provide more effective and durable treatment, extend treatment intervals, and reduce the burden of treatment, without safety concerns. This led to the approval of aflibercept, and brolucizumab, which also inhibit VEGF A. Recently and for the first time a dual-inhibition, anti-VEGF A and anti-angiopoietin-2, drug, faricimab, has been approved and shows promising results in the real-world setting. Also, a higher-dose and longer lasting drug, than conventional aflibercept (Eylea), Eylea HD has been developed and approved, resulting in superior therapeutic effects. Retinal physicians, ophthalmologists, and other retina care providers should familiarize themselves with the design and outcome of the pivotal approval studies and other studies that have shaped clinical care for DME and diabetic retinopathy (DR).