The FDA approved Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (DME), a sight-threatening eye disease occurring in people with diabetes.
Lucentis is an injection administered once a month by a healthcare professional, and it is intended for use along with good diabetic blood sugar control.
DME is a condition in which fluid leaks into the macule, the central part of the retina where sharp, straight-forward vision occurs. The fluid causes swelling of the macula resulting in blurring of vision.
The safety and effectiveness of Lucentis to treat DME were established in two clinical studies involving 759 patients treated and followed for a period of three years. Patients were randomly assigned to receive monthly injections of Lucentis at 0.3 mg or 0.5 mg, or no injections during the first 24 months of the study. After 24 months, all patients received monthly Lucentis at either 0.3 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 0.3 mg gained at least three lines of vision compared with 12-18% 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 lining the inside of the eyelids and covering the white part of the eye; eye pain; floaters; and increased pressure inside the eye (intraocular pressure).
Lucentis had previously been approved by the FDA to treat wet (neovascular) age-related macular degeneration (AMD), a condition in which abnormal blood vessels grow and leak fluid into the macula. Lucentis is also approved to treated macular edema following rentinal 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.