LEVERKUSEN (dpa-AFX) - Bayer HealthCare, a subgroup of German conglomerate Bayer AG (BYR.L, BAYRY.PK, BAYZF.PK), said that its Japanese subsidiary, Bayer Yakuhin Ltd., has submitted an application for marketing authorization for VEGF Trap-Eye (aflibercept solution for injection for the treatment of patients with diabetic macular edema or DME to the Ministry of Health, Labour and Welfare or MHLW in Japan.
The submission of VEGF Trap-Eye (aflibercept solution for injection) for DME in Japan is based on data from VISTA-DME and VIVID-DME studies. One-year data from the VIVID-DME and VISTA-DME trials were already presented at medical congresses in the U.S. and Europe. Both trials are planned to continue up to 148 weeks.
VEGF Trap-Eye has been approved under the brand name EYLEA in Europe, Japan, Australia, the United States, and in many other countries for the treatment of patients with neovascular age-related macular degeneration (wet AMD).
EYLEA has also been approved in Europe for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO) as well as in Japan, in selected countries in Asia, Latin America and the U.S. for the treatment of macular edema following CRVO.
Regulatory submissions have also been made in the EU, the U.S., and other countries, for EYLEA for the treatment of Diabetic Macular Edema, and in Japan additionally for the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV).
Separately, Regeneron Pharmaceuticals Inc. (REGN) announced that Bayer Yakuhin Ltd., has submitted an application for marketing authorization for EYLEA (aflibercept) Injection for the treatment of patients with diabetic macular edema to the Japanese Ministry of Health, Labour and Welfare.
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 percentage of net sales.
DME is a common complication of Diabetic Retinopathy, a disease affecting the blood vessels of the retina. Clinically significant DME occurs when fluid leaks into the center of the macula, the light-sensitive part of the retina responsible for sharp, direct vision. Fluid in the macula can cause severe vision loss or blindness.
DME is the most frequent cause of blindness in young and mid-aged adults.
Copyright RTT News/dpa-AFX
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