Regeneron Pharmaceuticals, Inc., a leading science-based biopharmaceutical company, announced that Bayer HealthCare's Japanese subsidiary, Bayer Yakuhin, Ltd. has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for Eylea (aflibercept) injection for myopic choroidal neovascularization (myopic CNV).

Eylea has already been approved in Japan for the treatment of patients with neovascular age-related macular degeneration (wet AMD), and macular edema secondary to central retinal vein occlusion (CRVO).  Marketing authorization applications have been submitted in Japan for the treatment of diabetic macular edema (DME) and macular edema secondary to branch retinal vein occlusion (BRVO).

Eylea is approved in the United States, European Union (EU) and other countries for the treatment of wet AMD, Macular Edema following CRVO, and DME.  Regulatory submissions have been made for Eylea in the US, EU, and Japan for Macular Edema following Branch Retina Vein Occlusion (BRVO).

Myopic CNV is a disease of the retina where new, abnormal blood vessels grow into the retina in persons who are severely myopic (typically more than minus six diopters).  The disease is characterized by an abnormally elongated eye with a physical stretching of the sclera, choroid, and retina resulting in degenerative and progressive changes.  These degenerative changes can induce the development of choroidal neovascularization.

Severe myopia is particularly common in Asia.  Myopic CNV is associated with high degrees of myopia and leads to progressive vision loss.  Myopic CNV has a poor prognosis and, if left untreated, can lead to legal blindness in the majority of patients. In East Asia, the prevalence of myopia is significantly higher than in West Asia, and appears to have an earlier onset.  In Japan myopic CNV is the second most common cause of blindness.

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 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 percentage of net sales.