On April 17, 2017, the U.S. Food and Drug Administration (FDA) expanded the approved use of eye medicine Lucentis (ranibizumab injection) to include treatment of all forms of diabetic retinopathy. (The medicine had previously been approved to treat diabetic retinopathy only in those with diabetic macular edema, or swelling of the central part of the retina.) With this decision, Lucentis becomes the first and only medicine approved to treat diabetic retinopathy in people with or without diabetic macular edema, according to manufacturer Genentech.
More than 7.7 million people in the United States are estimated to have diabetic retinopathy, which occurs when diabetes damages tiny blood vessels in the eye’s retina (the light-sensitive tissue at the back of the eye). The condition is the leading cause of vision loss in those with diabetes and the most common cause of blindness in adults ages 20–74.
Lucentis, which, in addition to diabetic retinopathy, is also approved to treat wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization, is administered via a monthly injection into the eye by a health-care professional.
The approval was based on a Priority Review of the NIH-funded Diabetic Retinopathy Clinical Research Network’s Protocol S study, which compared treatment with Lucentis to treatment with laser in people with diabetic retinopathy, with or without diabetic macular edema. The data showed that those who received a monthly injection of Lucentis experienced improvements in the severity of their diabetic retinopathy, whether or not they also had diabetic macular edema.
“In multiple clinical studies, Lucentis demonstrated a significant improvement of patients’ diabetic retinopathy” noted Sandra Horning, MD, chief medical officer and head of global product development for Genentech.
The most common eye-related side effects of Lucentis are redness of the eye, eye pain, floaters (small spots in vision), and increased eye pressure. The most common side effects not related to the eye are headache, nose and throat infections, lung/airway infections, and nausea. Serious side effects include inflammation inside the eye and, rarely, problems related to the injection, such as cataracts.
The cost of treatment with Lucentis is roughly $2,000 per month. The manufacturer offers programs to subsidize or eliminate the cost of the drug for people without insurance and those with insurance who meet certain criteria. For more information, visit the Lucentis Access Solutions or Lucentis Co-Pay Card websites or call (866) 422-2377.
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