Regeneron Pharmaceuticals, Inc., a leading science-based biopharmaceutical company, announced that Bayer HealthCare's Japanese subsidiary, Bayer Yakuhin, Ltd. has submitted a marketing authorization application for Eylea (aflibercept) injection for macular edema following branch retinal vein occlusion (BRVO) to the Japanese Ministry of Health, Labour and Welfare (MHLW).
Eylea has already been approved in Japan for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), and macular edema secondary to central retinal vein occlusion (CRVO). Marketing authorization applications have been submitted in Japan for the treatment of choroidal neovascularization secondary to pathologic myopia (myopic CNV) and for the treatment of diabetic macular edema (DME).
Eylea is approved in the United States, EU and other countries for the treatment of wet AMD, CRVO, and DME. Regulatory submissions have been made for Eylea in the US and EU for Macular Edema following BRVO.
RVO affects approximately one to two per cent of adults over the age of 40. There are two main types of RVO: BRVO and CRVO. BRVO is four times more common than CRVO, and CRVO generally is the most significant threat to vision.
RVO occurs when a blood clot obstructs a vein in the retina, the light-sensitive nerve tissue lining the back of the eye. The blockage causes a backup of blood and leads to poor blood supply in the affected retina. This results in the release of Vascular Endothelial Growth Factor (VEGF), a naturally-occurring protein in the body that causes blood vessels in the eye to become leaky. The leaky vessels lead to swelling in the center portion of the eye called the macula (a condition called macular edema), which is the most common cause of vision loss in RVO.
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.
Regeneron is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.9 billion (2013), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany.