Ophthalmologists Concerned About AMD Patients' Access To Avastin

Main Category: Eye Health / Blindness
Article Date: 18 Oct 2007 - 4:00 PDT

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The American Academy of Ophthalmology believes that Genentech's decision to stop sales of Avastin® (bevacizumab) to compounding pharmacies could have a significant impact on the care of patients with age-related macular degeneration (AMD).

"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 Academy. "Together with the retinal community, the Academy is evaluating how this decision will affect patient care."

Both Avastin and the FDA-approved Lucentis® (ranibizumab injection), another drug sold by Genentech, share a similar method of action by inhibiting vascular endothelial growth factor (VEGF). However, Lucentis was designed and tested specifically for treatment of wet AMD, while Avastin has only been FDA-approved for oncology indications. Prior to Lucentis' approval, many ophthalmologists had been using Avastin to treat wet AMD, and many doctors 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 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 Academy.

The Academy is seeking information from the FDA and Genentech to determine an appropriate and safe solution for patients and their doctors.

According to Genentech, Avastin will continue to be made available directly to physicians and hospital pharmacies through authorized wholesale distributors. However, ophthalmologists need compounding pharmacies to divide vials of Avastin into smaller doses for the treatment of AMD and other eye disorders.

About Age-Related Macular Degeneration

Macular degeneration is the deterioration or breakdown of the central portion of the macula or retina, which destroys central vision, making reading, driving and recognizing faces difficult. There are two general types of macular degeneration: dry and wet. Dry AMD is more common, but wet AMD progresses more quickly and accounts for about 90 percent of the severe vision loss associated with this disease.

Dry AMD occurs when the layer of cells beneath the retina begins to deteriorate, which affects the light-sensitive photoreceptor cells of the central retina. Wet AMD occurs when abnormal blood vessels begin to grow under the macula. These new blood vessels leak fluid or blood, causing central vision to blur or be lost. There is no cure for AMD.

Currently more than 1.75 million people in the United States have AMD and 7 million more people have earlier stages of the disease.

The Academy urges all patients, particularly those over the age of 50, to get regular eye exams by an ophthalmologist to screen for AMD and other eye disorders. For more information on AMD, visit http://www.aao.org.

About the American Academy of Ophthalmology

AAO is the world's largest association of eye physicians and surgeons - Eye M.D.s - with more than 27,000 members worldwide. Eye health care is provided by the three "O's" - opticians, optometrists and ophthalmologists. It is the ophthalmologist, or Eye M.D., who can treat it all: eye diseases and injuries, and perform eye surgery. To find an Eye M.D. in your area, visit the Academy's Web site at http://www.aao.org.

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