October 15, 2007
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Genentech to cease supplying bevacizumab to compounding pharmacies

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NEW YORK — Genentech will stop selling bevacizumab to certain pharmacies, according to a surgeon speaking here at the OSN New York meeting. The decision could significantly affect the care of patients with age-related macular degeneration, according to a press release from the American Academy of Ophthalmology.

Judy E. Kim, MD, surprised many attendees at the meeting when she announced that Avastin (bevacizumab, Genentech), which is used off-label for treating AMD patients, will no longer be supplied to compounding pharmacies.

Genentech will continue to make bevacizumab available directly to physicians and hospital pharmacies through authorized wholesale distributors. However, ophthalmologists need compounding pharmacies to divide vials of the drug into smaller doses for treating AMD and other eye disorders, according to the AAO release.

Bevacizumab and the U.S. Food and Drug Administration-approved Lucentis (ranibizumab, Genentech) share a similar method of action by inhibiting VEGF. However, ranibizumab was designed and tested specifically for treating wet AMD, while bevacizumab has only been FDA-approved for oncology indications.

"The primary concern of ophthalmologists is preserving the sight of our patients. Because Avastin has also been used off-label to treat diabetic retinopathy, macular edema and various other sight-threatening disorders, Genentech's decision to restrict availability of the drug has much wider implications than just for AMD patients," said H. Dunbar Hoskins Jr., MD, executive vice president of the AAO, in the release.

"Our main concern is for our patients with macular degeneration, who have come to rely on Avastin in their fight against potential vision loss," said Charles "Pat" Wilkinson, MD, president of the AAO, in the release. "Together with the retinal community, the Academy is evaluating how this decision will affect patient care."

The AAO is seeking information from the FDA and Genentech to determine an appropriate and safe solution for patients and their physicians, the AAO release said.

Before ranibizumab's approval, many ophthalmologists had been using bevacizumab to treat wet AMD, and many physicians continue to use it, citing good clinical results for patients. The National Institute of Health is sponsoring a head-to-head trial between the two drugs starting this year, the release said.

In her presentation at OSN New York, Dr. Kim noted that AMD is a complicated disease. In addition to trials comparing new pharmacologic treatments, researchers are conducting the AREDS 2 study, a multicenter, randomized trial designed to determine the effects of oral supplementation with macular xanthophylls and long-chain omega-3 fatty acids.

"Retina is the happening subspecialty right now," Dr. Kim said. "Retina issues are even in articles in the Wall Street Journal and the New York Times — mind you, not in the health section, but the business section."

Dr. Kim said surgeons need to know which drug is safer and the optimal dosage that is needed for treating AMD because "once a month injections for the rest of your life is not an acceptable option for many of our patients," she said.

Future treatments for AMD may include a cocktail of treatments, including frequent intravitreal steroids and anti-VEGF therapies, she said.