Lucentis Approved for Treatment of Diabetic Macular Edema (DME)

August 10th, 2012

On August 10, 2012, Lucentis® (ranibizumab injection) was approved for the treatment of diabetic macular edema (DME), an eye condition that causes blurred vision, severe vision loss and sometimes blindness.

Lucentis is only FDA-approved medicine shown to rapidly and significantly improve vision loss from DME and is the first major treatment advancement for the disease in more than 25 years. More patients who received Lucentis 0.3mg were able to read at least three additional lines (15 letters) on the eye chart after 24 months of treatment: RIDE: 34 percent, 0.3 mg versus 12 percent, control; RISE: 45 percent, 0.3 mg versus 18.1 percent, control (primary endpoint).

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 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.