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FDA Approves Diabetic Macular Edema Treatment

Women's eye closeup (Photos8.com)

(Photos8.com)

The U.S. Food and Drug Administration on Friday approved the drug ranibizumab, given by injection to treat diabetic macular edema, an eye disease that occurs in people with diabetes. Genentech, a division of the global pharmaceutical company Roche in South San Francisco, California, markets the drug under the name Lucentis.

Diabetic macular edema can cause blurred vision and severe vision loss leading to blindness. It occurs when diabetes damages blood vessels in the eye, a condition known as diabetic retinopathy, resulting in leakage of blood and fluid, as well as swelling. The Centers for Disease Control and Prevention says diabetes is the leading cause of new cases of blindness among adults aged 20 to 74. In addition, from 2005 to 2008, some 4.2 million individuals — 28.5 percent of people with diabetes aged 40 years or older  — had diabetic retinopathy.

Lucentis is already approved to treat two related disorders, wet age-related macular degeneration and 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. The drug is an engineered humanized monoclonal antibody fragment that acts as a vascular endothelial growth factor (VEGF) inhibitor. As described by Genentech, Lucentis binds to and inhibits VEGF-A, a protein considered important to the formation of new blood vessels and the leakiness of those vessels.

Two clinical trials tested the drug’s safety and effectiveness to treat diabetic macular edema, which involved 759 patients treated and monitored 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 Lucentis monthly, either at 0.3 mg or 0.5 mg.

Results based on eye-chart tests showed 34 to 45 percent of those treated with monthly Lucentis at 0.3 mg gained at least three lines of vision on the test chart compared with 12 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 effect reported in patients treated with Lucentis was bleeding of the conjunctiva, the tissue that lines the inside of the eyelids and covers the white part of the eye. Other adverse effects reported include eye pain, floaters, and increased pressure inside the eye.

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