Thursday, 26 March 2015

FDA OKs New Drug for Diabetes-Linked Eye Condition


Eylea injections appear to ease diabetic retinopathy, studies show

WebMD News from HealthDay

By Robert Preidt

HealthDay Reporter

WEDNESDAY, March 25, 2015 (HealthDay News) -- The U.S. Food and Drug Administration on Wednesday approved the use of Eylea, an injected drug, to treat diabetic retinopathy in patients with diabetic macular edema.

According to the U.S. Centers for Disease Control and Prevention, diabetic retinopathy is a leading cause of blindness in American adults. A third of those over 40 with diabetes have some form of the eye condition, according to 2008 data, the CDC said.

Overall, more than 29 million people in the United States have type 1 or type 2 diabetes, and diabetes remains the leading cause of new blindness among people aged 20 to 74, the CDC noted.

In some people who have diabetic retinopathy with macular edema, abnormal new blood vessels grow on the surface of the retina. If those new blood vessels break, severe vision loss or blindness can occur.

"The major cause of vision loss occurs when abnormal blood vessels leak, causing retinal swelling also known as macular edema," explained one expert, Dr. Mark Fromer, an ophthalmologist at Lenox Hill Hospital in New York City.

"Today's approval [of Eylea] gives patients with diabetic retinopathy and diabetic macular edema another therapy to treat this vision-impairing complication," Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.

Eylea is given by a doctor as an injection into the eye once a month for the first five injections, and then once every two months. It is meant to be used along with measures to control a patients' blood sugar, blood pressure and cholesterol levels, the FDA said.

The approval is based on the findings from two clinical trials that included a total of 679 diabetic retinopathy patients with diabetic macular edema. They were randomly assigned to receive Eylea or macular laser photocoagulation, a laser treatment that burns small areas of the retina.

After 100 weeks, patients taking Eylea had significant improvement in the severity of their diabetic retinopathy, compared with those who did not receive the drug, the FDA said.

source : FDA OKs New Drug for Diabetes-Linked Eye Condition

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