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
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.