Drug Approved to Treat Diabetic Retinopathy

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Diabetic retinopathy

On February 6, 2015, the U.S. Food and Drug Administration (FDA) expanded the approved use of eye drug Lucentis (ranibizumab injection) to include treatment of diabetic retinopathy in people who have diabetic macular edema.

More than 5.3 million adults in the United States are estimated to have diabetic retinopathy, which occurs when diabetes damages tiny blood vessels in the eye’s retina (the light-sensitive tissue at the back of the eye). In diabetic macular edema, or DME, fluid leaks into an area in the middle of the retina known as the macula, which is responsible for providing crisp vision and fine detail. The macula swells and vision blurs. DME affects approximately 750,000 Americans and about 10% of people who have diabetic retinopathy.

Lucentis, which is also approved to treat wet age-related macular degeneration, macular edema following retinal vein occlusion, and diabetic macular edema, is administered via a monthly injection into the eye by a health-care professional.

The safety and effectiveness of Lucentis for treating diabetic retinopathy with DME was established through two clinical trials involving 759 people who were treated and followed for three years. The data showed that those who received a monthly injection of 0.3 milligrams of Lucentis had significant improvement in the severity of their diabetic retinopathy at two years compared to those who did not receive Lucentis.

According to Edward Cox, MD, MPH, from 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.”

The most common side effects of Lucentis include bleeding of the conjunctiva (the tissue lining the inside of the eyelids and the white part of the eye), eye pain, floaters (small spots in vision), and increased intraocular pressure (pressure inside the eye). Serious side effects include detached retina and eye infection.

The cost of treatment with Lucentis for diabetic retinopathy in people with DME is $1,170 per 0.3-milligram dose. The manufacturer offers programs to subsidize or eliminate the cost of the drug for people without insurance and those with insurance who meet certain criteria. For more information, visit the Lucentis support page or call (866) LUCENTIS (582-3684).

For more information about Lucentis, see the press releases on the FDA or Roche websites or the Lucentis website.

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