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FDA warning on Avastin has few implications for ophthalmic use, investigator says
The Food and Drug Administration has added a new label warning to bevacizumab after reports of cases of reversible posterior leukoencephalopathy syndrome in patients taking the drug systemically for treatment of cancer. But the warning should have little bearing on ophthalmologic uses of the drug, according to Philip J. Rosenfeld, MD, PhD, of Bascom Palmer Eye Institute, one of the pioneer investigators of the off-label use of bevacizumab to treat exudative age-related macular degeneration.
According to a letter issued by Genentech, the maker of Avastin (bevacizumab), the brain-capillary leak syndrome was reported in less than 0.1% of cancer patients using the drug for its approved indications.
Dr. Rosenfeld explained to Ocular Surgery News that ophthalmologic uses of Avastin involve markedly lower dosing regimens and local rather than systemic delivery of the drug as in oncologic uses. Cancer patients receive high intravenous doses of the drug every 2 weeks, while AMD patients receive small monthly doses via intravitreal injection. Thus, he said, the risk of reversible posterior leukoencephalopathy syndrome (RPLS) in AMD patients is "probably quite remote."
Other common side effects related to Avastin use in cancer patients, such as hypertension, have not been seen in AMD patients treated with the drug, which suggests that RLPS is not likely for ophthalmic patients, he added.
"If you look at the many other drugs that we inject into the eye off-label, almost all of them have the possibility of serious systemic adverse events ... at their usual high dose systemically," Dr. Rosenfeld said. "[But] we don't see [these adverse events] when injected in small doses into the eye. So the issue with Avastin is not new."
Editor's Note: This is an updated version of an item that first appeared on OSNSuperSite.com on Friday, September 29. The original version contained errors that were brought to our attention by Philip J. Rosenfeld, MD. Ocular Surgery News regrets the errors.