The Food and Drug Administration has approved the first ever drug to treat a sight-threatening condition called diabetic macular edema, or DME. Everyone who has diabetes is at risk of developing the disease, which causes blurred vision, severe vision loss and sometimes blindness.
The drug, Lucentis, is administered once a month via injection.
“Lucentis represents a major development in treating people whose vision is impaired by diabetic macular edema,” said Dr. Mark Fleckner, a Fresh Meadows ophthalmologist specializing in treating disease of the retina. “Until now, the only treatment for this condition was laser surgery.”
Almost 26 million people in the United States have diabetes, according to the American Diabetes Association. Diabetic macular edema affects an estimated 560,000 Americans with diabetes, and about 75,000 new cases of DME are diagnosed each year. The condition causes fluid to leak into the macula, the center part of the retina responsible for sharp, straight-forward vision. The fluid makes the macula swell, causing vision to blur.
The safety and effectiveness of Lucentis to treat diabetic macular edema were established in two studies involving 759 patients. Patients were randomly assigned to receive monthly injections of Lucentis or of a placebo during a two-year period.
Significant gains in average vision were observed just seven days after the first treatment with Lucentis. The studies showed that 34 to 45 percent of those treated with monthly Lucentis gained at least three lines of vision on an eye chart, compared with 12 percent to 18 percent of those who did not receive Lucentis.
The Food and Drug Administration previously had approved the drug to treat age-related macular degeneration, a condition in which abnormal blood vessels grow and leak fluid into the macula.
Although the new treatment is considered an advance in preventing vision loss from DME, Dr. Fleckner emphasizes that the best thing people with diabetes can do to preserve their sight is to control their blood sugar, lead a healthy lifestyle and have regular eye exams.