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Streptococcal endophthalmitis outbreak evokes questions
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ORLANDO, Fla. — After a dozen people were affected in an outbreak of streptococcal endophthalmitis after intravitreal injection of bevacizumab, the question that should be asked is whether the preparation process is safe, posed a speaker here.
Roger A. Goldberg, MD, an ophthalmologist at Bascom Palmer Eye Institute, told colleagues here at Retina Subspecialty Day that preceded the annual meeting of the American Academy of Ophthalmology that the contamination occurred early in the supply chain. The affected patients all presented at Bascom Palmer Eye Institute within 1 to 6 days after receiving the injections of Avastin (bevacizumab, Genentech) from area retina specialists, Dr. Goldberg said.
The infecting organism was Streptococcus mitis and Streptococcus oralis, and the outbreak is under investigation by state and local health departments, the Centers for Disease Control and Prevention, and the US Food and Drug Administration, he said.
"A large component of this story is the fact that Avastin is used off-label for ocular use," Dr. Goldberg said.
In contrast to Lucentis (ranibizumab, Genentech), whose supply to physicians is direct from the distributor in a single-use vial, Avastin's journey to physicians is more complicated, with the drug being divided, compounded, repackaged and redistributed before reaching physicians, he said.
Rather than labeling the drug as inherently unsafe because it is supplied to physicians in this manner, Dr. Goldberg pointed to the excellent safety record of Bascom Palmer in its preparation of the drug for injection, having prepared 60,000 syringes for injection and having no incidences of contamination. He attributed that success to strict adherence to US Pharmacopeia guidelines for sterile preparation of compounds.
- Disclosure: Dr. Goldberg has no relevant financial relationships to disclose.