Reuters: Regulatory News: US FDA staff questions dosing of Roche's eye drug

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US FDA staff questions dosing of Roche's eye drug Jul 24th 2012, 12:32 WASHINGTON, July 24 | Tue Jul 24, 2012 8:32am EDT WASHINGTON, July 24 (Reuters) - U.S. drugs reviewers on Tuesday said Roche Holding AG's eye drug Lucentis seemed to help people who had some vision loss from diabetes, but questioned whether both doses of the drug were equally safe and effective. Staff from U.S. Food and Drug Administration reviewed Lucentis ahead of an advisory panel of outside experts, which meets on Thursday to vote on whether to recommend approval of the injectable drug. Lucentis is already approved for two other eye conditions, but the company is hoping to expand its use to people with diabetic macular edema, the most prevalent cause of moderate vision loss in patients with diabetes. There are currently no FDA-approved drugs for this condition.

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