[AmuRRR]

ФДА одобрила афлиберцепт для ДМО, говорят, лучше коагуляции

The US Food and Drug Administration (FDA) has expanded the indication of aflibercept ( Eylea, Regeneron) injection to treat diabetic retinopathy in patients with diabetic macular edema (DME).

"Diabetes is a serious public health crisis, affecting more patients every year," Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "Today's approval gives patients with diabetic retinopathy and diabetic macular edema another therapy to treat this vision-impairing complication."

In appropriate patients, aflibercept is injected into the eye every month for 5 months and then every 2 months, the FDA said.




The safety and efficacy of aflibercept to treat diabetic retinopathy in patients with DME were demonstrated in two clinical studies involving a total of 679 patients randomly assigned to receive aflibercept or macular laser photocoagulation (control group). At week 100, those treated with aflibercept showed significant improvement in the severity of their diabetic retinopathy compared with control patients, the FDA said.