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FDA Approves Lucentis® (Ranibizumab Injection) For Treatment Of Diabetic Macular Edema (DME)

About DME

DME is swelling of the macula, the central part of the retina responsible for sharp, central vision. 5 DME begins with diabetes, which can cause damage to blood vessels in the eye over time. When this happens, a patient is said to have diabetic retinopathy, the most common diabetic eye disease. The damaged blood vessels can leak blood and fluid, causing swelling and blurred vision, severe vision loss and sometimes blindness. 5

Nearly 26 million Americans have diabetes, which has become the leading cause of new cases of blindness in adults aged 20-74. 1 Among Americans aged 40 years and older, more than 4.2 million have diabetic retinopathy, according to the 2005-2008 National Health and Nutrition Examination Survey (NHANES). 6 A subsequent analysis estimates that 560,500 have DME. 2 It has also been estimated that up to 10 percent of people with diabetes will get DME during their lifetime. 7

About Lucentis

Lucentis is a prescription medicine for the treatment of patients with wet AMD, macular edema following RVO and DME.

Lucentis is a recombinant humanized monoclonal antibody fragment (lacking an Fc region). Lucentis is the first VEGF inhibitor specifically designed for use in the eye to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels.

In wet AMD, these new blood vessels grow under the retina and leak blood and fluid, causing rapid damage to the macula. Lucentis administered monthly in wet AMD clinical trials demonstrated an improvement in vision of three lines or more on the study eye chart in up to 41 percent of patients at two years. Nearly all patients (90 percent) treated monthly with Lucentis in those trials maintained (defined as losing < 15 letters) vision.

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