Macular degeneration is vision loss resulting from deterioration of the macula, which is the part of the retina that makes vision more detailed. According to UCLA Medical Center risk factors include, heredity, Caucasian race, cigarette smoking, a high-fat diet, female gender, and obesity. On August 30, the Food and Drug Administration (FDA) reported that at least 16 people in two states developed severe eye infections, and some have been blinded, from injections of the drug Avastin. Avastin, manufactured by Genentech, is approved to treat cancer but not eye disease. However, many retina specialists use Avastin off label because it costs only about $50 an injection, compared with $2,000 for Lucentis, another Genentech drug that has the same mode of action and is approved as an eye treatment. The off-label use of Avastin has saved Medicare and patients hundreds of millions of dollars a year. However, dividing a vial of Avastin into numerous tiny doses for injection into the eye introduces the risk of bacterial contamination. Apparently, that is what caused the cases, which occurred in Florida and Tennessee.
The FDA reported that at least 12 patients in Miami, treated at three clinics, had suffered eye inflammations. While all had impaired eyesight before the treatment, some lost all remaining vision in the treated eye. All the infections involved a single lot of Avastin and has been traced to a single pharmacy in Hollywood, Florida, that had repackaged the drug for use in the eye. In Tennessee, four patients received injections contaminated by bacteria. The Avastin doses were prepared in the pharmacy of the Veterans Administration Hospital in Nashville. One of the patients, Lloyd Mason Sylvis, 77, suffered an eye infection of Streptococcus viridans that spread to his brain. His son said that he is permanently blinded and permanently brain damaged. The Florida patients were apparently infected with Streptococcus oralis. It appears that bacterial contamination is solely responsible for the problem.
A clinical trial sponsored by the National Eye Institute found that Avastin and Lucentis were equivalent in preserving or improving vision after one year. However, last month, Avastin received another blow. An FDA advisory committee voted 6-0 on favor of the FDA’s proposal to revoke the approval of Avastin for use against advanced breast cancer.
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