Oct. 23, 2006
 
HEALTH: New Hope for Those with Macular Degeneration
 
By Josephine Marcotty
Minneapolis-St. Paul Star Tribune
 
First Maureen Marchio, 73, lost some of the sight in her left eye. Then six years ago her right eye started to get blurry, and the darkness started to close in around her.
 
At the time, most people with her condition faced a high risk of blindness. But she was lucky. She got an experimental drug as part of a research study on wet macular degeneration. She knew it was working, she said, when she went out to weed her garden one day and found she was pulling up the weeds and not the flowers.
 
"I shed a lot of tears when I first thought I was going blind," said Marchio, who lives in St. Paul, Minn. "I worried about what a burden I'd be on my kids."
 
The research, published earlier this month in the New England Journal of Medicine, found that the drug halted progression of the wet form of the disease in about 90 percent of the people who took it. That compared to about 50 percent in the group that received a fake treatment.
 
Partly on the basis of that research, the drug, Lucentis, which is administered by a monthly injection into the eye, was approved in June by the Food and Drug Administration (FDA). It is a long-awaited advance in treating macular degeneration, a disease that is the leading cause of blindness in people age 55 and older.
 
Along with the hope that it now provides to millions of elderly people, Lucentis has generated controversy over the price of sight. It costs a breathtaking $2,000 or more per month. But its manufacturer, Genentech, also makes a vastly cheaper drug, Avastin that may work as well and costs only $100 or less per treatment. However, Genentech hasn't done the research to find out how its efficacy compares to Lucentis.
 
Avastin is approved by the FDA for colon and lung cancer. But it works the same way as Lucentis. In fact, prior to Lucentis' approval, some doctors prescribed low doses of Avastin for macular degeneration, a legal practice called off-label use.
 
After a chorus of complaints from doctors about the cost of Lucentis and the need for comparative studies -- including two editorials in the New England Journal of Medicine -- the federal government last week announced it would pay $16 million for a head-to-head comparison of the two drugs.
 
"That's a very good idea," said Dr. Timothy Olsen, an ophthalmology professor at the University of Minnesota and an expert in macular degeneration.
 
In the meantime, doctors are more likely to use Lucentis because it has the track record to prove that it works. Fortunately for people like Marchio, Medicare and other insurance providers cover Lucentis.
 
Macular degeneration, like the rising incidence of Alzheimer's, is part of the price we pay for longevity. As the average life expectancy has risen around the world, so has the number of people who lose their vision from macular degeneration. Today, one out of three adults over the age of 75 has one of the two forms of the disease, either wet or dry.
 
Olsen said that it is impossible to predict who will get it. But it's been linked to smoking, cardiovascular disease, a high-fat diet and high blood pressure.
 
The dry form is by far the most common, representing 85 to 90 percent of all cases. It occurs when small fatty deposits build up under the center part of the retina, called the macula. They block nutrition from reaching the light-sensing cells, which slowly die off, creating a blurry spot in the center of the field of vision.
 
There are no drugs or surgical treatments for the dry form. But high doses of zinc and antioxidants may slow the disease in those with advanced cases. The new drugs are for the wet form, which, though less common, is far more devastating. It causes more rapid and severe vision loss. It occurs when abnormal blood vessels grow beneath the macula, on the back of the eye. They bleed and leak fluid, causing the macula to bulge, distorting central vision.
 
Both Lucentis and Avastin, and a third drug called Macugen, work by inhibiting the growth of blood vessels. The eye condition can sometimes be treated with a laser that destroys the blood vessels, but about half the time they grow back, said Olsen.
 
Dr. Abdhish Bhavsar, director of clinical research at the Retinal Center in Minneapolis and one of the drug researchers, said that 25 to 40 percent of people treated with Lucentis see some improvement in their vision. But for most, the drug stops it from getting worse.
 
Distributed by Scripps Howard News Service, www.scrippsnews.com.