Bayer HealthCare’s Japanese subsidiary Bayer Yakuhin has submitted a marketing authorisation application to Japan’s Ministry of Health, Labour and Welfare (MHLW) for vascular endothelial growth factor (VEGF) Trap-Eye (aflibercept solution for injection) to treat patients with diabetic macular edema (DME).
The application for VEGF Trap-Eye 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 2mg dosed monthly and VEGF Trap-Eye 2mg dosed every two months (after five 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.
The company said that both the VIVID-DME and VISTA-DME trials are planned to continue up to 148 weeks.
Bayer HealthCare member of the executive committee and head of global development Joerg Moeller said: “The number of patients suffering from diabetes on a worldwide basis continues to increase, and with it the need for new treatment options.
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“Whatever a person’s age, vision impairment impacts everyday tasks and has a detrimental effect on quality of life.
“With this filing, we hope to make a significant contribution towards alleviating the impact of this disease for the future in Japan.”
In Europe, Japan, Australia, the US and in many other countries, VEGF Trap-Eye has been approved under the brand name Eylea to treat patients with neovascular age-related macular degeneration (wet AMD).
Eylea has already been approved in Europe for treating visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO), as well as in Japan, the US, selected Asian and Latin American countries for the treatment of macular edema following CRVO.
Under the global development of Eylea, Regeneron has exclusive rights to the drug in the US, while Bayer has exclusive marketing rights outside the US, where the companies equally share the profits from its sales, except for Japan where Regeneron receives a royalty on net sales.
Image: Diabetic macular edema. Photo: courtesy of GeeJo.