Bayer HealthCare has obtained approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its Eylea (aflibercept solution for injection) to treat patients with diabetic macular edema (DME).
The approval was based on positive data from the VIVID-DME and VISTA-DME trials and one open label single arm safety study in Japanese patients.
Bayer HealthCare global development head Joerg Moeller said: "Clinically significant DME is a leading cause of vision loss in the working age population suffering from diabetes.
"In Japan, the retirement age tends to be rising due to declining birthrates and an ageing population.
"The loss of even a single line of letters on ETDRS eye chart may impact a patient’s ability to work, and could mean they leave the workforce early."
Aflibercept solution for injection of 2mg was dosed monthly and 2mg of aflibercept was also dosed every two months in the Phase III VIVID-DME and VISTA-DME trials.
The studies achieved the primary endpoint of significantly greater improvements in best-corrected visual acuity (BCVA) from baseline compared to laser photocoagulation at 52 weeks.
Bayer noted that patients further treated with aflibercept solution for injection every two months on average gained more than two lines of vision at one year against laser, measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart.
Eylea was approved in 80 countries to treat patients with neovascular age-related macular degeneration, while in 60 countries to treat visual impairment due to macular edema secondary to central retinal vein occlusion.
In Japan, Eylea was approved to treat myopic choroidal neovascularisation, and was also approved to treat DME in more than 30 countries.
Based on the data from Phase III in patients with branch retinal vein occlusion, Bayer submitted applications for marketing authorisation in Europe and Japan.
The company collaborated with Regeneron Pharmaceuticals on the global development of Eylea.
Image: Office building of Bayer HealthCare located in Wedding district of Berlin, Germany. Photo: courtesy of ChristianSchd.