(RxWiki News) U.S. Food and Drug Administration officials have approved Lucentis (ranibizumab injection) as the first drug capable of treating a severe eye disease that develops in individuals with diabetes.
Lucentis, marketed by Genentech, was approved to treat diabetic macular edema as a monthly injection.
Diabetic macular edema (DME) occurs when fluid leaks into the macula, the retina's center, causing swelling that blurs vision.
"Get eye exams regularly to pinpoint diseases early."
Renata Albrecht, MD, director of the Division of Transplant and Ophthalmology Products in the FDA’s Center for Drug Evaluation and Research, noted that all diabetic patients are at risk of developing the eye condition. Approval of the new treatment represents a major development in treating patients with vision blurred by DME, Dr. Albrecht said.
In the United States, about 26 million have either type 1 or 2 diabetes. About 3.9 million Americans with diabetes reported vision difficulties in 2010.
The drug was approved following the FDA's review of a pair of clinical trials involving 759 DME patients who were treated over a 3-year period. The patients were randomly assigned to receive either 0.3 milligrams of Lucentis injected monthly, 0.5 milligrams of injected Lucentis or no injections over 24 months. After the initial two years, all patients received one of the two Lucentis doses.
Researchers then measured the number of patients with improved vision, defined by their ability to read smaller lines on a traditional eye chart.
Patients receiving the lower dose of the drug averaged a vision increase between 34 percent and 45 percent. They were able to read three additional lines on the eye chart on average.
Participants that did not receive eye injections were found to have vision that improved between 12 percent and 18 percent. Additional benefits were not found with the higher Lucentis dosage.
"It is the first drug to be approved for use in DME. There of course remains controversy because less expensive alternative drugs (Avastin) were not included in the clinical trials which showed a benefit. Currently the only other treatment for DME has been focal laser treatment," noted Dr. Chris Quinn, an optometrist with Omni Eye Associates.
"The use of Lucentis and other anti VEGF [vascular endothelial growth factor] drugs in combination with laser looks to be superior to treatment with laser alone."
FDA officials previously approved Lucentis to treat wet age-related macular degeneration, the leading cause of blindness among older adults. It also is approved to treat macular edema after retinal vein occlusion, a small-vein blockage that can cause fluid to leak into the macula.