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

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. LUCENTIS is not for everyone.

Some LUCENTIS patients have serious side effects related to the injection. These include serious infections inside the eye, detached retinas, and cataracts. If your eye becomes red, sensitive to light, or painful, or if you have a change in vision, call or visit your eye doctor right away. Other uncommon serious side effects include inflammation inside the eye and increased eye pressure. These side effects can make your vision worse. Some patients have had increased eye pressure before and within 1 hour of an injection. Your eye doctor should check your eye pressure and eye health after your LUCENTIS injection.

Uncommonly, LUCENTIS patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes.

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 and nausea.

LUCENTIS is for prescription use only.

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.

Supporting Information

Sandra Horning, M.D.

“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.”