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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 http://firstwatch.jwatch.org/, 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 (http://www.fda.gov/bbs/topics/NEWS/2006/NEW01405.html). 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 (http://www.gene.com/gene/products/
information/pdf/healthcare-provider-letter.pdf) 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 (http://firstwatch.jwatch.org/cgi/content/full/2006/705/4), 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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