FDA Approves New Treatment Option for People with Diabetic Retinopathy

April 17th, 2017

On April 17, 2017, the FDA granted approval to Lucentis® (ranibizumab injection) 0.3 mg for the monthly treatment of all forms of diabetic retinopathy. With this approval, Lucentis becomes the first and only FDA-approved medicine to treat diabetic retinopathy in people who have been diagnosed either with or without diabetic macular edema (DME), a complication of diabetic retinopathy that causes swelling in the back of the eye.


News in brief

  • First and only medicine FDA-approved to treat all forms of diabetic retinopathy
  • Granted Priority Review Designation by the FDA based on analysis of results from a National Institutes of Health (NIH)-funded collaborative group study
  • The most common cause of vision loss in people with diabetes, diabetic retinopathy is the leading cause of blindness among adults aged 20 to 74 and affects nearly 7.7 million people in the U.S.

Important Safety Information

You should not use LUCENTIS if you have an infection in or around the eye or are allergic to LUCENTIS or any of its ingredients. LUCENTIS is a prescription medication given by injection into the eye, and it has side effects. Some LUCENTIS patients have had detached retinas and serious eye infections. If your eye becomes red, sensitive to light, or painful, or if you have a change in vision, call or visit your eye doctor immediately. Some LUCENTIS patients have had increased eye pressure before and within 1 hour of an injection. Uncommonly, LUCENTIS patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes. Fatal events were seen more often in patients with DME and DR with LUCENTIS compared with patients who did not receive Lucentis. Although there were only few fatal events, which included causes of death typical of patients with advanced diabetic complications, these events may be caused by Lucentis.

Some LUCENTIS patients have serious side effects related to the injection. These include serious infections inside the eye, detached retinas, and cataracts. The most common eye-related side effects are increased redness in the white of the eye, eye pain, small specks in vision, and increased eye pressure. The most common non–eye-related side effects are nose and throat infections, anemia, nausea and cough. Ask your doctor if you have questions or want more information.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

For additional safety information, please see LUCENTIS full prescribing information in the link above.


Sandra Horning, M.D.

“Diabetic retinopathy is the leading cause of vision loss among working-aged adults in the U.S. between the ages of 20 and 74. We are very pleased that Lucentis is now FDA-approved to treat retinopathy in people with and without DME. 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.”