Regeneron Pharmaceuticals, Inc. announced that Eylea (aflibercept) injection has been approved by the European Commission for the treatment of visual impairment due to Diabetic Macular Edema (DME).  Bayer Healthcare plans to launch Eylea in DME in the EU this quarter.

"DME is the leading cause of vision loss in working-age adults in much of the developed world, and we believe Eylea will be an important new treatment option for these patients," said George D. Yancopoulos, chief scientific officer of Regeneron and president of Regeneron Laboratories ."We are pleased that Eylea is now approved in both the US and the EU for three important ophthalmic indications.

Eylea was approved in the United States for the treatment of wet Age-related Macular Degeneration (AMD) in 2011, for the treatment of Macular Edema following Central Retinal Vein Occlusion (CRVO) in 2012, and for DME in July 2014. Eylea has also been approved in the EU and other countries for use in wet AMD and Macular Edema following CRVO.  Regulatory submissions have also been made in Japan, Asia Pacific, and Latin America for the treatment of DME.  In Japan, Eylea has been additionally submitted for approval to regulators for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV).  A regulatory submission has been made in the US and the EU for Eylea for the treatment of Macular Edema following Branch Retinal Vein Occlusion (BRVO).

Diabetic Macular Edema (DME) or "swelling of the macula" is a common complication in the eyes of patients with diabetes.  It is the most frequent cause of vision loss in patients with diabetes and eventually can lead to blindness. Visual impairment due to DME is estimated to affect 3-4 per cent of people with diabetes and is therefore the most frequent cause of blindness in young and middle-aged adults in most developed countries.  As the incidence of diabetes has been steadily climbing, it is projected that the number of people impacted by DME will also grow. DME occurs when blood vessels in the retina are damaged by chronic high blood sugar levels caused by diabetes.  This allows fluid from blood vessels to leak into the retina, causing macular swelling.  Fluid in the macula can cause severe vision loss or blindness.  The macula is the part of the retina responsible for central fine vision.

Vascular endothelial growth factor (VEGF), a member of a naturally occurring family of growth factors in the body, appears to play a critical role in the development of DME.  Increased VEGF production contributes to the vascular disruptions and leakage that characterize DME, as well as the formation of new blood vessels (a process known as angiogenesis).  

Eylea is a vascular endothelial growth factor (VEGF) inhibitor formulated as an injection for the eye.  Eylea 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.