Aflibercept (EYLEA®) Injection has been recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of visual impairment due to macular edema secondary to branch or central retinal vein occlusion (BRVO/CRVO).
The European Union (EU) submission is based on the previously-approved indication for macular edema secondary to CRVO and the positive data from the Phase 3 VIBRANT study.
EYLEA is approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), which includes both CRVO and BRVO, and Diabetic Macular Edema (DME). EYLEA has also been approved in the EU and other markets for use in wet AMD and DME.
About Retinal Vein Occlusion
Retinal Vein Occlusion (RVO) is the second most common retinal vascular disease and is a significant cause of visual impairment. Of the two main types of retinal vein occlusion – CRVO and BRVO – the latter is more common. In BRVO, a blockage occurs in the blood vessels branching from the main vein draining the retina, resulting in the release of vascular endothelial growth factor and consequent retinal edema. Retinal Vein Occlusion (RVO) has a significant global impact with an estimated 16.4 million people affected worldwide, including around 13.9 million with branch retinal vein occlusion (BRVO) and 2.5 million with central retinal vein occlusion (CRVO).
About Aflibercept (EYLEA®) Injection for Intravitreal Injection
EYLEA is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye. The drug is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. EYLEA helps prevent VEGF-A and PLGF from interacting with their natural VEGF receptors as shown in preclinical studies.