Monday, August 13, 2012

Lucentis OK'd for Diabetic Eye Disease

SILVER SPRING, Md. -- The FDA has approved ranibizumab (Lucentis) for treatment of diabetic macular edema (DME), the agency said Friday.
Under the approval, the drug is to be given by intravitreal injection once a month. Patients should also have good glycemic control.
Diabetic macular edema is one of the many complications of type 1 and type 2 diabetes. Microvascular defects caused by excess blood sugar leads to fluid leakage inside the retina. The end result is impaired vision, which can be severe enough to qualify as blindness.
Ranibizumab, an inhibitor of vascular endothelial growth factor, was already approved for neovascular ("wet") age-related macular degeneration and for macular edema resulting from retinal vein occlusion.
Just two weeks ago, an FDA advisory committee had backed the DME indication for ranibizumab. The panel unanimously recommended approval at a dose of 0.3 mg per injection and also, by an 8-2 vote, a 0.5-mg dose.
The FDA's announcement of the approval did not indicate whether the drug's label would include the higher dose. The agency said that, in the drug's trials in DME, "no additional benefit was observed" with the 0.5-mg injection.
At the 0.3-mg dose, data from two trials involving a total of 759 patients indicated that 34% to 45% of those receiving the drug gained at least three lines of vision on a standard eye chart, compared with 12% to 18% of untreated control patients, the FDA said.
Adverse effects associated with ranibizumab included conjunctival bleeding, eye pain, "floaters," and elevated intraocular pressure.
Ranibizumab is marketed by Genentech of South San Francisco, Calif., a Roche subsidiary.
John Gever
Senior Editor
John Gever, Senior Editor, has covered biomedicine and medical technology for 30 years. He holds a B.S. from the University of Michigan and an M.S. from Boston University. Now based in Pittsburgh, he is the daily assignment editor for MedPage Today as well as general factotum on the reporting side. Go Pirates/Penguins/Steelers!


FDA approves ranibizumab to treat diabetic macular edema.

Bloomberg News (8/10, Edney) reports that the US Food and Drug Administration has approved Roche Holding AG's Lucentis (ranibizumab) as a monthly injection to treat diabetic macular edema, "a leading cause of vision loss." The medication is the "first approved drug to treat the condition" which affects "more than 500,000 people in the US." Ranibizumab was previously approved "to treat a similar disease called wet age-related macular edema." The AP (8/10) reported, "The agency cleared the drug for diabetic macular edema, a condition that causes swelling and blurred vision in patients with diabetes."
        The San Francisco Chronicle (8/10) reported that the Centers for Disease Control and Prevention has said that "diabetes is the leading cause of new cases of blindness among Americans ages 20 to 74." It cites "Jason Ehrlich, medical director of ophthalmology at Genentech, [who] said Lucentis improved patients' eyesight in clinical trials faster than the standard treatment of laser therapy." Yet, "some physicians say Lucentis...will continue to cost patients much more than a competing drug, Avastin, which they contend works just as well in the eye."
        The Wall Street Journal (8/10, Dooren, Subscription Publication) reported the approved one-time dosage is 0.3 mg, which is expected to cost $1,170.
        Reuters (8/10, Yukhananov) reported that while the normal treatment of laser surgery rarely leads to improved vision, ranibizumab was reported to lead to patients seeing at least 15 more letters on an eye chart.
        HealthDay (8/10) added, "Commonly reported side effects of Lucentis include bleeding of the eye's conjunctiva tissue, eye pain, floaters and increased pressure inside the eye."

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