FDA approves new drug for treatment of diabetic eye disease.
The U.S. Food and Drug Administration (FDA) approved Lucentis (ranizumab injection) for the treatment of a diabetic complication that may cause blindness. Diabetic macular edema (DME) is a degenerative eye disease that can cause blindness in people suffering from diabetes.
DME is attributable to a fluid leak in the part of the eye—specifically the macula, or center of the retina—responsible for controlling sharp, straightforward vision. The FDA says the leak into the macula causes swelling, blurring vision to the point of blindness.
The CDC says both types of diabetes affect approximately 26 million people in the United States. Additionally, the CDC says diabetes is the leading cause of new blindness in people from 20-74 years old. In 2010, 3.9 million diabetic adults reported eye trouble, making Lucentis a welcome development in the treatment of a serious epidemic.
Renata Albrecht, M.D., director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research, says, “Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema.” In terms of the new treatment, Dr. Albrecht was optimistic, saying, “Today’s approval represents a major development for the treatment of people whose vision is impaired by DMA as a complication of their disease.”
Lucentis, which the FDA says in a monthly injection administered by a health care professional, has been used in the past to treat similar complications involving macular leakage such as wet (neovascular) age-related macular degeneration (AMD) and macular edema caused by vein occlusion.
The FDA says the safety of the drug was determined by two three-year long clinical studies involving a total of 759 diabetics. Patients were randomly assigned monthly Lucentis injections at low dosages for the first 24 months, after which the FDA says the trial included all patients at equally low dosages. The FDA says the studies measured patients’ progress using eye charts. The results showed that 34 to 45 percent of those patients treated with Lucentis displayed a three-line improvement in sight at a low dosage of 0.3 mg.
The FDA says these results were in comparison to a control group (those patients who did not receive injections) that displayed a 12 to 18 percent improvement in sight. Slightly higher dosages of Lucentis at 0.5 mg were said by the FDA to have the same effect as the slightly lower 0.3 mg dosage. The most common side effects of Lucentis are bleeding in the tissue lining the inside and white parts of the eye (conjunctiva), eye pain, floaters, and increased pressure inside the eye.