Regeneron Pharmaceuticals, announced that Bayer HealthCare's Japanese subsidiary, Bayer Yakuhin, has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for Eylea (aflibercept) injection for diabetic macular edema (DME).

Eylea has already been approved in Japan for the treatment of patients with neovascular age-related macular degeneration (wet AMD), macular edema secondary to central retinal vein occlusion (CRVO), and myopic choroidal neovascularisation (myopic CNV). A marketing authorisation application has been submitted in Japan for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO).

Eylea is approved in the US for wet AMD, DME and macular edema following retinal vein occlusion (RVO). Eylea has been approved in almost 80 countries for the treatment of patients with wet AMD and around 60 countries for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion. Eylea is also approved for the treatment of DME in over 30 countries. Bayer has submitted an application for marketing authorization in Europe for Eylea in macular edema following 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 around three percent of people with diabetes around the world and is the most frequent cause of blindness in young and mid-aged adults in most developed countries.

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 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 characterise 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

Bayer HealthCare and Regeneron are collaborating on the global development of Eylea. Regeneron maintains exclusive rights to Eylea in the United States. Bayer HealthCare has licenced 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 percentage of net sales.