FDA panel gives nod to drug for diabetic eye disease
(Reuters) - A U.S. Food and Drug Administration panel on Thursday 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 recommended both 0.3 milligram and 0.5 milligram doses of the drug known generically as ranibizumab after reviewing clinical research showing it clearly helps diabetic patients who suffer from the vision-robbing condition.
Agency regulators will now consider the panel's recommendations in deciding whether to approve the drug 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.
The condition is currently treated by laser surgery to stop blood vessels from leaking. The treatment can slow vision loss, but it rarely leads to vision improvement.
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