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FDA Says Ranibizumab May Help Diabetic Eye Condition
The FDA staff, however, asked an advisory panel of experts to consider whether both doses of Lucentis (0.3 mg and 0.5 mg) are equally safe and effective. The advisory panel will meet on July 26 to vote on whether to recommend approval of an expanded use of the drug, which is administered monthly by injection.
Lucentis is already indicated for two other eye conditions––wet age-related macular degeneration (the leading cause of blindness in the elderly) and macular edema following retinal vein occlusion. Roche hopes to widen the drug’s use to people with diabetic macular edema (DME), the most common cause of moderate vision loss in patients with diabetes. No FDA-approved drugs are currently available for the treatment of DME, but Roche’s cancer drug Avastin (bevacizumab) is extensively used off-label for that indication.
DME is a swelling of the retina that occurs in diabetics who suffer from retinopathy––a diabetic eye disease in which damaged blood vessels leak fluid into the retina. The disorder causes blurred vision and severe vision loss. About 75,000 new cases of DME are estimated to occur among Americans each year, and about 560,000 Americans are currently affected by the disease.
For more information, read the Reuters news article.