Industry News — Clinical Updates
Bayer's Japan Subsidiary Submits Market Authorization for Eylea for Macular Edema Following BRVO
Bayer Yakuhin, Ltd, a subsidiary of Bayer HealthCare, has submitted a marketing authorization application for Eylea (aflibercept) for macular edema following branch retinal vein occlusion (BRVO) to the Japanese Ministry of Health, Labour and Welfare.
Eyela is approved in Japan for the treatment of patients with neovascular age-related macular degeneration (AMD) and macular edema secondary to central retinal vein occlusion (CRVO). Marketing authorization applications have also been submitted in Japan for the treatment of choroidal neovascularization secondary to pathologic myopia (myopic CNV) and for diabetic macular edema (DME).
Eylea is approved in the United States, European Union (EU), and other countries for the treatment of wet AMD, CRVO, and DME. Regulatory submissions have been made in the US and EU for Eylea for macular edema following BRVO.
Bayer HealthCare and Regeneron collaborate on the global development of Eylea. Regeneron maintains exclusive rights in the US, and Bayer HealthCare has exclusive marketing rights outside the US.
Updated September 9, 2014