FDA approves 'breakthrough' therapy for diabetic eye disorder

The FDA announced Wednesday that it has granted “breakthrough therapy designation” to the drug Eylea, and expanded its approved use for the treatment of diabetic retinopathy in patients with diabetic macular edema.

The agency last month also approved Lucentis (ranibizumab injection) 0.3 mg to treat diabetic retinopathy in patients with DME.

Diabetes and its myriad attendant physiological complications afflict thousands of elderly in long-term care settings. According to the American Diabetes Association, early detection of retinopathy in individuals with diabetes is critical in preventing visual loss, but current methods of screening fail to identify a sizable number of high-risk patients. Moreover, the currently available interventions for diabetic macular edema target only advanced stages of the disease.

Diabetic retinopathy is the most common diabetic eye disease and is a leading cause of blindness in adults in the United States, the FDA notes. According to the Centers for Disease Control and Prevention, types 1 and 2 diabetes affect more than 29 million people in the United States and is the leading cause of new blindness among people ages 20 to 74 years old. In 2008, 33% of adults with diabetes aged 40 years or older had some form of diabetic retinopathy. In some cases of DR with diabetic macular edema, abnormal new blood vessels grow on the surface of the retina. Severe vision loss or blindness can occur if the new blood vessels break.

Eylea is administered by a physician as an injection into the eye once a month for the first five injections and then once every two months. It is intended to be used along with appropriate interventions to control blood sugar, blood pressure and cholesterol, according to the FDA.