WebMD Medical News
Daniel J. DeNoon
Laura J. Martin, MD
April 29, 2011 -- Fifty-dollars worth of Avastin prevents blindness from age-related macular degeneration (AMD), and does it just as well as $2,000 worth of Lucentis, a federally funded clinical trial finds.
AMD, the leading cause of blindness in the U.S., is the result of abnormal growth and leakage of blood vessels in the retina. Lucentis, specifically designed for AMD treatment, prevents abnormal blood vessel growth. It works in almost exactly the same way as Avastin, an older cancer drug.
While ophthalmologists were waiting for Lucentis to work its way through the drug-approval pipeline, they began treating AMD patients with small doses of Avastin, even though it had never been tested for safety or effectiveness in AMD patients.
But it seemed to work, so Avastin became a common treatment for AMD. Five years ago, Lucentis won FDA approval as the only treatment proven to prevent blindness in people with AMD. That proof was based on clinical trials in which patients received monthly injections of Lucentis.
Everyone would have switched to Lucentis except for one thing: cost. Genentech makes both Avastin and Lucentis. For cancer treatment, huge doses of Avastin are needed. The tiny dose needed for AMD costs only $50. A single dose of Lucentis costs $2,000.
Medicare had little choice but to pay for Lucentis, as it was the only proven drug for AMD. But ophthalmologists continued to prefer Avastin. And instead of monthly injections of either drug, doctors were treating patients only on an as-needed basis -- that is, only when their AMD appeared to be acting up. Patients prefer the as-needed treatment, as both Lucentis and Avastin must be injected directly into the eye.
Which treatment was right? The National Eye Institute, part of the National Institutes of Health, stepped in. The National Eye Institute paid for a clinical trial in which Lucentis and Aventis competed head-to-head among 1,208 AMD patients at 44 U.S. sites. The study also looked at whether monthly injections were better then as-needed injections.
Now the one-year results of that study are in. The bottom line: Avastin works just as well as Lucentis, and as-needed injections work just as well as monthly injections.
Unlike earlier treatments, which slowed the rate at which patients went blind, both Lucentis and Avastin stop vision loss for nearly all patients and actually improve many patients' vision.
"On all measures of visual acuity, the two drugs were virtually identical," study leader Daniel F. Martin, MD, chairman of the Cole Eye Institute at the Cleveland Clinic, said at a news teleconference.
"This study is unequivocal in saying there is minimal and likely no difference between as-needed and monthly treatment," Paul A. Sieving, MD, PhD, director of the National Eye Institute, said at the news conference.
Moreover, the study found that neither Avastin nor Lucentis increased patients' risk of stroke, heart attack, or death -- side effects seen in cancer patients given vastly higher doses of Avastin.
So why would any doctor give a patient $2,000-a-dose Lucentis when $50-a-dose Avastin works just as well?
"When one is selecting drugs for an individual patient, cost is one of many factors, not the only one," Martin said. "In our study we describe the average patient. ... We clearly show equivalence between the two drugs, but that does not mean there are not subsets of patients who might respond better to one drug over another. At the end of the day it is a choice between the doctor and the patient."
Genentech had no role in funding, performing, or interpreting the study. Study drugs were paid for by Medicare and by the National Institutes of Health.
The Avastin/Lucentis study, called the CATT study, was published in the April 28 early online edition of the New England Journal of Medicine.
SOURCES:Martin, D.F. New England Journal of Medicine, online, April 28, 2011.Rosenfeld, P.J. New England Journal of Medicine, online, April 28, 2011.News release, National Eye Institute.News teleconference, National Eye Institute, April 28, 2011.Daniel F. Martin, MD, chairman, Cole Eye Institute, Cleveland Clinic.Paul A. Sieving, MD, PhD, director, National Eye Institute.News release, American Academy of Ophthalmology.
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