Monday, 9 February 2015

FDA Approves 1st Drug for Diabetic Retinopathy


To be used in those with diabetic macular edema, injections fight leading cause of blindness

WebMD News from HealthDay

By Dennis Thompson

HealthDay Reporter

FRIDAY, Feb. 6, 2015 (HealthDay News) -- The U.S. Food and Drug Administration on Friday approved the drug Lucentis (ranibizumab) to treat diabetic retinopathy in patients with diabetic macular edema.

A leading cause of blindness among adults in the United States, diabetic retinopathy is the most common diabetic eye disease, the agency said in a news release.

In 2008, 33 percent of adults with diabetes aged 40 or older had some form of diabetic retinopathy. In some patients who have diabetic retinopathy with diabetic macular edema, abnormal new blood vessels grow on the surface of the retina and if the vessels burst severe vision loss or blindness can occur, the agency said.

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

Lucentis must be injected into the eye once a month by a doctor, and should be used alongside treatments to control blood sugar, blood pressure and cholesterol, according to the FDA.

The drug works by inhibiting leakage of blood vessels and deterring the growth of blood vessels into the retina of the eye, said Dr. Pravin Dugel, a retinal specialist at Retinal Consultants of Arizona and an investigator in the medication's two clinical trials.

Diabetic retinopathy causes progressive damage to the retina, the light-sensitive lining at the back of the eye. The condition causes blood vessels to leak fluid into retinal tissue, and promotes the growth of abnormal new blood vessels on the surface of the retina.

About 7.7 million Americans with diabetes have suffered vision loss because of diabetic retinopathy, according to the U.S. National Institutes of Health. There currently are an estimated 29 million diabetics in the United States.

When given promptly, Lucentis can alter the progression of diabetic retinopathy and save vision, Dugel said.

"It truly is disease-modifying," Dugel said. "In certain patients, if you treat up front, you can actually modify the disease in the eye."

source : FDA Approves 1st Drug for Diabetic Retinopathy

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