FDA Approves Genentech Medicine for Diabetic Retinopathy in People with Diabetic Macular Edema
February 6th, 2015
On February 6, 2015, the FDA approved Lucentis® (ranibizumab) for the treatment of diabetic retinopathy in people with diabetic macular edema (DME).
News in brief
- First eye medicine approved for treatment of diabetic retinopathy with diabetic macular edema
- Granted Breakthrough Therapy Designation and Priority Review by FDA
- Diabetic macular edema can occur at any stage of diabetic retinopathy, a leading cause of blindness in American adults
- Fourth Lucentis indication for treatment of serious eye diseases since 2006
Supporting Information
Important Safety Information
What important safety information should I know about LUCENTIS?
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 talk to your doctor and see the LUCENTIS full prescribing information.
“While there are various options for treating diabetic macular edema, before today none were approved showing improvement in retinopathy. With today's approval, people with diabetic macular edema now have a FDA-approved medicine that showed meaningful improvements in retinal damage from diabetes, in addition to the established improvement in vision.”