Bayer gets approval in Japan for Eylea to treat diabetic macular edema

The approval is based on positive data from the Phase III VIVID-DME and VISTA-DME trials and one open label single arm safety trial in Japanese patients (VIVID-Japan).

During the trials, aflibercept solution for injection 2mg dosed monthly and aflibercept solution for injection 2mg dosed every two months, achieved the primary endpoint of significantly greater improvements in best-corrected visual acuity (BCVA) from baseline compared to laser photocoagulation at 52 weeks.

In addition, patients treated with Eylea every two months on average gained more than two lines of vision at one year vs laser, as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart.

Bayer HealthCare member of the Executive Committee and head of Global Development Dr 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 aging 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.

"The approval of Eylea in Japan in this important indication is great news for the increasing number of patients suffering from DME."

In Japan, Eylea has already been approved to treat patients with neovascular age-related macular degeneration (wet AMD), macular edema secondary to central retinal vein occlusion (CRVO), and myopic choroidal neovascularization (myopic CNV).

In the US, Eylea is approved for wet AMD, DME and macular edema following retinal vein occlusion (RVO).

Eylea is being developed by Bayer as part of its collaboration with Regeneron Pharmaceuticals.

Image: Bayer HealthCare’s research site at Berlin, Germany. Photo: courtesy of Bayer AG.