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The U.S. Food and Drug Administration has approved Roche's Lucentis to treat diabetic macular edema (DME), a sight-threatening eye disease that occurs in people with diabetes.

Lucentis is an injection to be administered once a month by a health care professional, and should be used along with good diabetic blood sugar control.

"Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema," said Renata Albrecht, director of the Division of Transplant and Ophthalmology Products in FDA's Center for Drug Evaluation and Research. "[The] approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease."

DME is a condition in which fluid leaks into the macula, the center part of the retina where sharp, straight-forward vision occurs. The fluid makes the macula swell, causing vision to blur.

Researchers tested the safety and effectiveness of Lucentis in two clinical studies involving 759 patients. The patients where were treated and followed for three years. 

Patients were randomly assigned to receive monthly injections of Lucentis at 0.3 milligrams (mg) or 0.5 mg, or no injections during the first 24 months of the studies. After 24 months, all patients received monthly Lucentis either at 0.3 mg or 0.5 mg.

Results showed that between 34 percent and 45 percent of those treated with monthly Lucentis 0.3 mg gained at least three lines of vision compared with 12 percent to 18 percent of those who did not receive an injection. No additional benefit was observed with the higher monthly Lucentis dose of 0.5 mg.

The most common side effects reported in patients treated with Lucentis include bleeding of 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.

Lucentis was once 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 also is approved to treat macular edema following retinal vein occlusion, a blockage of the small veins that carry blood away from the retina that can cause fluid to leak into the macula.

According to the Wall Street Journal, the drug will cost $1,170.

According to the Centers for Disease Control and Prevention, type 1 and 2 diabetes affects about 26 million people in the United States and is the leading cause of new blindness among people ages 20 to 74 years. In 2010, 3.9 million adults diagnosed with diabetes reported trouble with their vision.