The Food and Drug Administration has approved Genentech's Lucentis as a treatment for all forms of diabetic retinopathy, the leading cause of blindness among working age adults in the country.
The ranibizumab injection is a monthly treatment for individuals who have been diagnosed with or without diabetic macular edema (DME). Diabetic retinopathy complication causes swelling in the back of the eye.
While Lucentis received FDA approval in 2015 for the treatment of diabetic retinopathy in those with DME, the medicine was granted priority review designation for the treatment of diabetic retinopathy without DME based on results from a National Institutes of Health-funded collaborative group study.
"We are very pleased that Lucentis is now FDA-approved to treat retinopathy in people with and without DME," Sandra Horning, chief medical officer and head of global product development for Roche/Genentech, said. "In multiple clinical studies, Lucentis demonstrated a significant improvement of patients’ diabetic retinopathy, and it is the first and only anti-VEGF therapy approved to treat all forms of diabetic retinopathy."
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