The European Commission has approved Regeneron Pharmaceuticals' Eylea (aflibercept) injection for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO).
"We are pleased with the approval of Eylea in the EU in a second indication," said George D. Yancopoulos, chief scientific officer of Regeneron and president of Regeneron Laboratories. "Our phase 3 studies showed that Eylea improved visual outcomes significantly in macular edema following CRVO. This additional approval of Eylea is great news for patients in Europe suffering from macular edema following CRVO, a debilitating disease affecting central vision."
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 CRVO in September 2012. Eylea has also been approved in Europe, Japan, Australia, and in several other countries for use in wet AMD and in selected countries in South America 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.
Over 66,000 people in major European countries and more than 100,000 people in the United States are estimated to suffer from CRVO. CRVO is caused by obstruction of the central retinal vein that leads to a back up of blood and fluid in the retina. This causes retinal damage and loss of vision. Release of vascular endothelial growth factor (VEGF) contributes to increased vascular permeability in the eye and macular edema. It has been shown that anti-VEGF treatment may help decrease vascular permeability and edema in the retina in patients with CRVO.
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. However, in certain diseases, such as wet age-related macular degeneration, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema. Scarring and loss of fine-resolution central vision often results. 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.
Eylea is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. Eylea acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of their cognate VEGF receptors.
Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.