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Lucentis Approved for Diabetic Retinopathy

The Food and Drug Administration has expanded the indication for Lucentis (ranibizumab injection) to treat diabetic retinopathy in patients with diabetic macular edema.

Diabetic retinopathy is the most common diabetic eye disease and is a leading cause of blindness in adults in the United States. According to the National Eye Institute, 7.7 million people age 40 and older have diabetic retinopathy, and this number is projected to increase to approximately 11 million by 2030.

In some cases of diabetic retinopathy with diabetic macular edema (DME), "abnormal new blood vessels grow on the surface of the retina. Severe vision loss or blindness can occur if the new blood vessels break," according to the Centers for Disease Control and Prevention.2

To help prevent degenerative eye disease, the newly approved agent "is administered by a physician as an injection into the eye once a month," noted a press release from the Food and Drug Administration.3  It is intended to be used along with appropriate interventions to control blood sugar, blood pressure, and cholesterol.

“Diabetes is a serious public health crisis, affecting more patients every year,” said Edward Cox, MD, MPH, 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.”3

Safety Record

The drug’s safety and efficacy to treat diabetic retinopathy with DME were established in two clinical studies involving 759 participants who were treated and followed for 3 years. In the two studies,  participants being treated with Lucentis showed significant improvement in the severity of their diabetic retinopathy at 2 years compared to patients who did not receive an injection.

The most common side effects include bleeding of the conjunctiva, the tissue that lines the inside of the eyelids and covers the white part of the eye; eye pain; floaters; and increased pressure inside the eye (intraocular pressure). Serious side effects include infection within the eyeball (endophthalmitis) and retinal detachments.

The FDA previously had approved Lucentis to treat DME and macular edema secondary to retinal vein occlusions, both of which cause fluid to leak into the macula resulting in blurred vision. Lucentis also is approved to treat wet (neovascular) age-related macular degeneration (AMD), a condition in which abnormal blood vessels grow and leak fluid into the macula.

Lucentis is marketed Genentech, a subsidiary of Roche.

Updated on: February 20, 2015
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Diabetic Eye Disease: Overview
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