FDA Clears Ranibizumab for Diabetic Retinopathy With DME

Megan Brooks


February 06, 2015

The US Food and Drug Administration (FDA) has expanded the approved use of ranibizumab (Lucentis, Genentech, Inc) injection (0.3 mg) 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 news release. "Today's approval gives patients with diabetic retinopathy and diabetic macular edema the first significant therapy to treat this vision-impairing complication."

The safety and efficacy of ranibizumab to treat diabetic retinopathy with DME were established in two clinical studies involving 759 participants who were treated and followed for three years. In the two studies, treatment with ranibizumab led to significant improvement in severity of diabetic retinopathy at two years compared with that in patients who did not receive the drug, the FDA says.

The most common side effects include bleeding of the conjunctiva, eye pain, floaters, and increased intraocular pressure. Serious side effects include endophthalmitis and retinal detachment.

The FDA granted ranibizumab for diabetic retinopathy with DME breakthrough therapy designation and reviewed this new use for the drug under the agency's priority review program, which provides for an expedited review of drugs that demonstrate the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition.

The FDA previously had approved ranibizumab to treat DME and macular edema secondary to retinal vein occlusions, both of which cause fluid to leak into the macula, which can result in blurred vision.

Ranibizumab is also approved in the United States for the treatment of neovascular (wet) age-related macular degeneration. Ranibizumab is administered by intravitreal injection once monthly.

Diabetic retinopathy is the most common diabetic eye disease and is a leading cause of blindness in adults in the US, the FDA says.


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