The U.S. Food and Drug Administration (FDA) this month approved a drug to treat diabetes patients with macular edema (DME), a condition that results in blurred vision when fluid leaks into the retina and causes swelling. Left untreated, macular edema can lead to blindness.
Manufactured by Roche's Genentech subsidiary, Lucentis is injected into the patient's eyes to improve vision. Past laser treatments focused on halting the degeneration of the eye but could not restore eyesight.
In clinical trials, 759 patients received Lucentis in varying doses over the course of three years. At least a third of the patients receiving the consistent injections improved their sight by three lines on an eye chart, which physicians consider significant. The most common side effects reported during the trials were bleeding of the conjunctiva, eye pain, floaters, and increased pressure inside the eye.
The drug first was approved by the FDA to treat wet age-related macular degeneration (AMD) and macular edema that results from vein blockage.
Lucentis is intended to be used once a month in diabetes patients who have controlled blood sugar, or glucose. Unfortunately, stabilizing blood sugar is an ongoing battle for most people with diabetes. They start the process by attempting to regulate their diet and exercise. If those behavior modifications do not work, physicians recommend medications, such as Actos.
Actos Linked to Increased Risk of Macular Edema
Takeda Pharmaceuticals' Actos is one of the most widely prescribed medications for patients suffering from type 2 diabetes. But here's the catch: Although taking Actos may allow diabetes patients to stabilize their glucose levels so they can reap the benefits of Lucentis, it comes at a high price -- severe complications that include the onset or worsening of macular edema. So, are patients taking Actos putting themselves at a higher risk for eventually going blind?
It certainly would seem so. In a study publicized in June that was reported in the Archives of Internal Medicine, 1.3 percent of patients who took a thiazolidinedione (TZD) drug such as Actos for a year were found to have macular edema. Patients who did not take the drug had an incidence rate of 0.2 percent. Adjusting for variables such as age and use of other medications still left Actos patients with more than a twofold greater risk after one-year and 10-year follow-ups, the study reports.
Macular edema in diabetes patients is a widespread concern in the United States. "According to the Centers for Disease Control and Prevention, diabetes (type 1 and type 2) ... is the leading cause of new blindness among people ages 20 to 74 years," the FDA reports. In 2010, nearly 4 million adults with diabetes reported problems with their eyesight.