The FDA has approved Genentech’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 approved Lucentis to treat wet (neovascular) age-related macular degeneration (AMD), as well as macular edema following retinal vein occlusion. An injection administered once a month by a health care professional, the new approval of Lucentis for DME is intended to be used along with good diabetic blood sugar control.
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 0.3mg or 0.5mg, 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% and 45% of those treated with monthly Lucentis 0.3mg gained at least three lines of vision compared with 12% to 18% of those who did not receive an injection. No additional benefit was observed with the higher monthly Lucentis dose of 0.5mg.