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Regeneron Reports Positive Phase 3 Data For EYLEA® (aflibercept) Injection In Macular Edema Following Branch Retinal Vein Occlusion

EYLEA was approved in the United States for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD) in November 2011 and for Macular Edema following Central Retinal Vein Occlusion (CRVO) in September 2012.  EYLEA has also been approved in Europe, Japan, Australia, and in many other countries for use in wet AMD and in Europe and other countries for Macular Edema following CRVO.

Bayer HealthCare and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States.  Bayer HealthCare licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLEA, except for Japan where Regeneron receives a royalty on net sales.

About the Phase 3 VIBRANT Study

The Phase 3 VIBRANT trial was a double-masked, randomized, active-controlled study of 183 patients with Macular Edema following Branch Retinal Vein Occlusion.  Patients received either intravitreal EYLEA 2 mg every four weeks or laser treatment, through week 24.  The primary objective of the study was to evaluate the efficacy and safety of EYLEA in improving best-corrected visual acuity compared to laser treatment at week 24.  The study is ongoing through week 52. 

About EYLEA ® (aflibercept) Injection for Intravitreal Injection

Vascular Endothelial Growth Factor (VEGF) is a naturally occurring protein in the body.  Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues and organs.  In Central Retinal Vein Occlusion (CRVO), a blockage occurs in the main blood vessel that transports deoxygenated blood away from the retina.  VEGF levels are elevated in response, contributing to macular edema.  In Branch Retinal Vein Occlusion (BRVO), a blockage occurs in one of the branching retinal veins that drain blood from the retina.  The blockage leads to a backup of blood and fluid collection (macular edema) that can cause impairment of vision.

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