On August 10, the drug Lucentis, licensed by Genentech, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of diabetic macular edema (DME). Studies of Lucentis (ranibizumab injection)—funded by Breakthrough T1D and the National Institutes of Health’s (NIH) Special Diabetes Program (SDP)—demonstrated the drug’s safety and effectiveness in inhibiting the effects of the VEGF protein, which causes tiny blood vessels in the eye to leak fluid, leading to the swelling of the retina that is the cause of DME. Phase III clinical trials with Lucentis showed that the drug was effective at preventing, halting, and in some cases reversing vision loss arising from DME. Between 34 and 45 percent of study participants who received Lucentis treatment for three years regained sight of at least three lines on a standard eye chart. Following these and other clinical studies, Breakthrough T1D provided testimony at an FDA Advisory Meeting on July 26 to recommend the approval of Lucentis. A major complication of type 1 and type 2 diabetes, DME is a leading cause of blindness in adults. As many as 10 percent of people diagnosed with diabetes will develop DME in their lifetimes. The FDA’s approval of Lucentis is an important advancement for people with DME in the United States.
