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    HARBOR results lead to ranibizumab label change

    Two-year outcomes support individualized dosing in patients with wet AMD


    Findings from the HARBOR study on ranibizumab for wet macular degeneration prompted new labeling for a potentially less frequent than monthly dosing, depending on individual responses to treatments.


    Nashville, TN—Results from the HARBOR study an anti-vascular endothelial growth factor (VEGF) drug approved for various retina disorders, has led to the drug’s third label update in 18 months.

    “In the HARBOR study, it’s astounding that 93% of the patients in the [ranibizumab (Lucentis, Genentech)] 0.5 mg arm did not need monthly injections over the 2-year study,” said Brandon G. Busbee, MD, in private practice, Nashville, TN. “HARBOR—along with the other AMD studies—really confirmed that in order to get clinically meaningful vision results, patients do not need to have monthly injections.”

    After the initial three loading doses, Dr. Busbee said HARBOR also confirmed what many clinicians believe—“there’s definitely an individualized response to ranibizumab.” In HARBOR, the average injection frequency over 2 years for patients in the PRN arm was 9.9 weeks, with a mean gain of 7.9 letters.

    Although patients may not be dosed monthly, they’re still being seen monthly during a PRN regimen “because you’re waiting for fluid to come back and vision to decrease. You really can’t afford to have those patients out of your office for too long,” Dr. Busbee said.

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