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Ranibizumab (brand name Lucentis) associated with an increased incidence of stroke

Henry I. Bussey, Pharm.D., FCCP, FAHA
April, 2007

Physician's first watch, a service of Journal Watch at, recently summarized new data on the risk of stroke with a new medication used to prevent loss of vision in one form of age-related macular degeneration (AMD). According to the FDA, wet-type AMD accounts for 10% of all AMD but causes about 80% of the associated vision loss ( The problem - and resultant loss of vision - results from the formation of additional leaky blood vessels. Ranibizumab has anti-angiogenesis effects that inhibit the formation of new blood vessels and has been shown to result in maintenance of vision in 95% of patients compared to 60% of those receiving sham (placebo) injections. In a dear doctor letter in January, 2007 (
) the manufacturer, Genentech, reported an interim analysis of a safety study in which 1.2% of patients receiving the 0.5 mg dose and 0.3% of those receiving the 0.3 mg dose experienced a stroke at a mean follow-up of 230 days of treatment; a statistically significant difference (p = 0.02). Further safety analysis is expected later this year. As pointed out previously by Journal Watch (, the use of ranibizumab has sparked public controversy because some physicians have been using bevacizumab (brand name Avastin) - another drug that inhibits growth of blood vessels - off label (without FDA approval) to treat wet AMD because they believe that it works just as well but costs substantially less ($17 per monthly injection of bevacizumab vs. $1,950 per monthly injection of ranibizumab). Both drugs are made by Genentech.

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Sunday, May 26, 2024