Eylea meets primary endpoint in Ph III DME study

German pharma major Bayer (BAYN: DE) revealed this morning (August 6) that, in the Phase III VIVID-DME and VISTA-DME trials of Eylea (aflibercept; VEGF Trap-Eye) for the treatment of diabetic macular edema (DME), Eylea 2mg dosed monthly and Eylea 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.

“DME is a leading cause of vision loss in adults under the age of 50 suffering from diabetes,” said Kemal Malik, a member of the Bayer HealthCare executive committee and head of global development, adding: “We look forward to being able to offer medical benefit to patients with this new treatment option for DME.”

The VIVID-DME and VISTA-DME trials are similarly designed, randomized, double-masked, active control trials to evaluate the safety and efficacy of VEGF Trap-Eye in patients with DME. Patients in both trials were randomized to receive either VEGF Trap-Eye 2 mg monthly, VEGF Trap-Eye 2 mg every two months (after five initial monthly injections), or the comparator treatment of laser photocoagulation. Both trials are planned to continue up to 148 weeks.