An injection administered once a month by a health care professional, Lucentis is intended to be used along with good diabetic blood sugar control.
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.
According to the Centers for Disease Control and Prevention, diabetes (type 1 and type 2) 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.
"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, M.D., director of the Division of Transplant and Ophthalmology Products in FDA’s Center for Drug Evaluation and Research. "Today's approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease."
The drug's safety and effectiveness to treat DME were established in two clinical studies involving 759 patients who 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.
The studies measured the number of patients who gained vision, as measured on an eye chart. 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 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).
The FDA previously had approved Lucentis 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.
Lucentis is marketed by South San Francisco, Calif.-based Genentech.
FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.