UPDATE: US advisers back Roche drug for diabetic eye disease
[Replaces story posted Jul 26, 2012, as 20120726elin010, with updated version.]
By David Morgan
WASHINGTON (Reuters) - A U.S. Food and Drug Administration advisory panel recommended Roche Holding AG's Lucentis eye drug for treatment of diabetic macular edema, a leading cause of vision loss among working-age people.
The FDA advisory committee of outside experts on Thursday recommended both 0.3 milligram and 0.5 milligram doses of the drug after reviewing clinical research showing it clearly helps diabetic patients who suffer from the vision-robbing condition.
However, some panel members expressed concern about evidence linking higher doses of the drug to adverse events including death.
Agency regulators will now consider the panel's recommendations in deciding whether to approve the drug, known generically as ranibizumab, for treatment of diabetic macular edema, or DME.
Lucentis, which is made by Roche unit Genentech and administered by monthly injection, is already approved for two other eye ailments.
There are currently no FDA-approved drugs for DME. Today, the condition is treated by laser surgery to stop blood vessels from leaking. The treatment can slow vision loss, but it rarely leads to vision improvement.
"The committee's recommendation is an important step towards improving the care of Americans with diabetic macular edema. If approved by the FDA, this will be the first major development for treating diabetic macular edema in more than 25 years," Genentech said in a statement.
The leading cause of vision loss among diabetics, DME occurs when leaking blood vessels in the eye cause swelling at the center of the retina. The result is a progressive blurring of images near the center of a patient's field of vision, and sometimes blindness.
About 75,000 new cases of DME are estimated to develop among Americans each year. Genentech says that about 560,000 in total are affected by the disease.
Clinical trials involving more than 750 patients found that people who received both the 0.3 mg and 0.5 mg doses of Lucentis over 24 months witnessed an improvement in their ability to read eye charts.
Nearly 40 percent of patients on the lower dose and 50 percent on the higher dose saw improvements.
The research also showed both doses to be generally safe. But there were more deaths at the higher dose - 11 people who received the 0.5 mg dose died during the trials, compared with seven who received the 0.3 mg dose and three who were given a placebo.
Lucentis is already approved to treat wet age-related macular degeneration - the leading cause of blindness among the elderly. It is also approved for macular edema following retinal vein occlusion (RVO), a swelling or thickening of the part of the retina responsible for central vision.
If approved for DME, Lucentis will likely compete with a highly promising drug being tested by Regeneron Pharmaceuticals Inc and Roche's own cancer drug Avastin, which works in a similar manner as Lucentis.
Avastin, which is not approved for eye disease, costs a fraction of the Lucentis price when cut into the small doses needed for eye injection. It has been used extensively off-label in place of Lucentis, hurting sales of the eye drug.
A U.S. government study last year found the two drugs to be similarly effective for macular degeneration treatment.
Genentech has said Avastin increased the risk of stroke and heart attack in cancer trials and noted that diabetics are already at much higher risk for serious heart problems.
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