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Anti-VEGF Agent Aflibercept Approved for Treatment of Macular Edema Secondary to Retinal Vein Occlusion in the European Union
Anti-VEGF agent aflibercept (EYLEA®) has been approved by the European Commission for the treatment of visual impairment due to Macular Edema secondary to Retinal Vein Occlusion (RVO). The new indication includes Macular Edema following Branch Retinal Vein Occlusion (BRVO) in addition to the previously approved indication of Macular Edema secondary to Central Retinal Vein Occlusion (CRVO). The recommended treatment approach in the European Union (EU) is to initiate the therapy with one injection per month, continuing monthly treatment until maximum visual acuity is achieved and/or there are no signs of disease activity. Treatment may then be continued with a treat and extend regimen with gradually increased treatment intervals to maintain stable visual and/or anatomic outcomes.
EU approval is based on positive data from the Phase 3 VIBRANT study in patients with visual impairment due to macular edema secondary to BRVO.
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 is also approved in the EU and other markets for use in wet AMD and DME.
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).