The U.S. FDA has approved Roche’s Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (DME), a sight-threatening eye disease that occurs in people with diabetes. 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 given as an injection, and administered once a month by a health care professional.
The FDA approved the drug following two clinical studies establishing the drug’s safety and effectiveness to treat DME. The two clinical studies involved 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).