FDA Approves Lucentis To Treat Diabetic Macular Edema

The FDA approved Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (DME), a sight-threatening eye disease that occurs in people with diabetes. Lucentis is an injection administered once a month by a health care professional. It 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 the FDA’s Center for Drug Evaluation and Research.


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).


See the FDA announcement