Bayer Yakuhin, Ltd., a Japanese affiliate of Bayer HealthCare, has submitted an application for marketing authorization for VEGF Trap-Eye (aflibercept solution for injection) for the treatment of patients with diabetic macular edema (DME) to the Ministry of Health, Labour and Welfare (MHLW) in Japan.
“Clinically significant DME is a leading cause of vision loss in the working age population suffering from diabetes. The number of patients suffering from diabetes on a worldwide basis continues to increase, and with it the need for new treatment options. Whatever a person`s age, vision impairment impacts everyday tasks and has a detrimental effect on quality of life,” said Dr Joerg Moeller, member of the Bayer HealthCare Executive Committee and head of Global Development. “With this filing, we hope to make a significant contribution towards alleviating the impact of this disease for the future 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. In the phase III VIVID-DME and VISTA-DME trials, VEGF Trap-Eye 2 milligrams (mg) dosed monthly and VEGF Trap-Eye 2 mg dosed every two months (after 5 initial monthly injections), achieved the primary endpoint of significantly greater improvements in best-corrected visual acuity (BCVA) from baseline compared to laser photocoagulation at 52 weeks. One-year data from the VIVID-DME and VISTA-DME trials were already presented at medical congresses in the US 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 US for the treatment of macular edema following CRVO. Regulatory submissions have also been made in the EU, the US, 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).
Bayer HealthCare and Regeneron Pharmaceuticals, Inc. 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.
The phase III DME programme consists of three double-masked trials: VIVID-DME, VISTA-DME, and VIVID-EAST, and one open label single arm safety trial in Japanese patients (VIVID-Japan). All three double masked studies have three treatment arms, where patients are randomized to receive either VEGF Trap-Eye 2 mg monthly, VEGF Trap-Eye 2 mg every two months (after 5 initial monthly injections), or the comparator treatment of laser photocoagulation. Based on protocol specified criteria, patients were eligible to receive rescue treatment from week 24 onwards. Rescue treatment was adjunct laser treatment for both VEGF Trap-Eye arms and VEGF Trap-Eye 2mg for the laser group. The primary endpoint of these three studies is the mean change in best-corrected visual acuity from baseline, as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart, a standard chart used in research to measure visual acuity. The VIVID-DME, VISTA-DME and VIVID-EAST studies are ongoing.
DME is a common complication of Diabetic Retinopathy (DR), 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.
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