DR with DME is a common diabetic eye disease and one of the leading causes of blindness in adults younger than 55 in the U.S.
Approximately 750,000 Americans have DME, with about 10 percent of those suffering from DR. It is caused when high blood sugar levels damage the fine blood vessels of the retina, the light-sensitive tissue needed for good vision. Approximately 29 million Americans are diabetic, and the longer diabetics have the disease, the higher the risk for developing DR, especially when diabetes is poorly managed.
"While there are various options for treating diabetic macular edema, before today, none were approved showing improvement in retinopathy," Sandra Horning, Genentech's chief medical officer and head of global product development, said. "With today's approval, people with diabetic macular edema now have an FDA-approved medicine that showed meaningful improvements in retinal damage from diabetes, in addition to the established improvement in vision."
The FDA granted Breakthrough Therapy Designation and Priority Review to the medication, which has been studied in 21 clinical trials worldwide in more than 9,080 patients.
Genentech became a member of the Roche Group in March 2009. The company was founded in 1976.