The Japanese Ministry of Health, Labour and Welfare has approved Regeneron Pharmaceuticals' Eylea (aflibercept) injection for the treatment of macular edema following Central Retinal Vein Occlusion (CRVO).
"We are pleased with the approval of Eylea in Japan in the macular edema following CRVO indication, a significant cause of visual impairment in adults," said George D Yancopoulos, MD, Ph. D., chief scientific officer of Regeneron and president of Regeneron Laboratories. "This approval reflects our commitment, along with our partner Bayer HealthCare, to bring Eylea to patients worldwide."
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 Central Retinal Vein Occlusion (CRVO) in September 2012. Eylea has also been approved in the European Union (EU), Japan, Australia, and in several other countries for use in wet AMD. Eylea has also been approved by the European Commission for the treatment of visual impairment due to macular edema following CRVO, as well as in selected countries in Asia and Latin America. Regulatory submissions have also been made in the US and the EU for Eylea in diabetic macular edema.
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.
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, 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, known in the scientific literature as VEGF Trap-Eye, 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 collaborating with Bayer HealthCare on the global development of Eylea. Eylea is currently approved for the treatment of wet AMD in approximately 50 countries outside the US, including Japan and Australia and countries in the EU. Eylea has also been approved by the European Commission for the treatment of visual impairment due to macular edema secondary to CRVO. Regeneron also maintains exclusive rights to Eylea in the United States.
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