Posted on 08/06/2006 7:07:14 AM PDT by Dark Skies
Marion Kleinfeld got up one Sunday morning, picked up the newspaper, settled down to read it, and couldn't see the words.
Kleinfeld, 79, of Delray Beach, Fla., already blind in her right eye, lost sight in her other eye because of a condition called wet age-related macular degeneration, AMD, the leading cause of blindness in people over 55. Leaking blood vessels in the back of the eye cause a large black spot in the center of vision.
"I could not see at all. It was very frightening," she said.
After years of having to tell patients losing their eyesight to wet AMD that nothing could be done, doctors now can offer hope. On June 30, the U.S. Food and Drug Administration approved Lucentis to treat wet AMD, which strikes an estimated 155,000 people a year. The approval came seven years after the drug's maker, Genentech Inc., began the first test in humans, said Dawn Kalmar, a spokesperson for the company based in San Francisco.
About 95 percent of patients regain their sight after treatment, and in some, vision gradually gets better than it was before the onset of the disease.
When Kleinfeld's first eye developed the condition several years ago there was no treatment. But this time as soon as she got to retina specialist Mark Michels' office in South Florida, she got an injection that restored her vision.
"Within a week I could see again, and by the end of the month, I was seeing perfect," she said. "It was amazing how quick it happened."
Genentech makes another drug, Avastin, which retina specialists have discovered may work just as well as Lucentis and costs much less. It is approved by the FDA to treat cancer by stopping formation of blood vessels around tumors, but doctors can use it "off-label" to stop the leaking blood vessels at the back of the eye.
Lucentis, which is covered by Medicare, costs about $2,000 for one eye injection each month; Avastin costs $17 to $50 a month for one injection.
Kleinfeld got her treatment as part of a clinical trial of Lucentis, a biological drug that blocks a protein, VEGF, which causes abnormal blood vessel growth. She continued to get injections in her left eye once a month for 24 months as part of the study. She said the injections were not painful. Now she goes about every three months.
Clinical trials are continuing in South Florida and other locations to determine how many treatments should be given and how often.
"It's just a gift from God as far as I'm concerned," Kleinfeld said. "I can see my grandchildren. I have five beautiful grandchildren."
Dr. Philip Rosenfeld, professor of ophthalmology at the University of Miami Miller School of Medicine, said he initially tried Avastin in patients who were going blind and who were not being helped by earlier drugs approved to treat wet AMD.
"There's been a slow progression of therapies -- first there was Visudyne, which slowed the progression in some people, then Macugen, that slows the progression, then came Lucentis and Avastin, and for these drugs there's the possibility of improvement (of vision), which we've never seen before," Rosenfeld said.
According to Genentech, patients are not only able to read and drive again, about 40 percent can read three more lines on the eye chart than they could before the treatment. Avastin has had similar results for some patients.
"We just tried (Avastin) in a couple of patients at first with miraculous results," said Rosenfeld, who practices at UM's Bascom Palmer Eye Institute and has been involved in drug trials for wet AMD treatments for more than a decade, including Lucentis.
"We published those (Avastin) case reports," he said, and discussed his findings at a national meeting of retina specialists about a year ago.
"Outside the U.S., people can't really afford Lucentis," he said. "This spread like wildfire, so by the time the World Congress (of retina specialists) was held in February, the whole world was treating patients."
Rosenfeld said one Wall Street analyst estimated that Avastin had captured 80 percent of the market before Lucentis won FDA approval.
"It just goes to show you that if you provide an effective drug for an unmet need at an affordable price, there is no need for marketing and advertising," Rosenfeld said.
People who have Medicare, which covers the cost, usually choose Lucentis, he said. But people who don't have a supplemental policy may opt for the cheaper drug because the Medicare co-pay for Lucentis is about $400 and most people would have to pay that once a month.
Rosenfeld said the National Institutes of Health may sponsor a trial comparing Lucentis and Avastin.
While Kleinfeld's sight has been restored in the eye treated with Lucentis, there is still no treatment for the eye that lost vision years ago. There are no drugs that work for that. Some research is being done in animals using embryonic stem cells in the hope of being able to grow replacement tissue that will restore sight, but experts said clinical trials in humans are likely years away.
I see Dark Skies.
-bflr-
bump
Someone is making a boat load of money off patients and taxpayers.
I see a bump in Genentech stock
Bump
Bookmarking
bump for later
Thank you for posting this.
Good post. Thanks. I lost my right eye to retinal detachments a couple of years ago, so it is good to know that I may not lose the other one.
Thanks for the post DS! This is a good article to save for future reference! :)
My pleasure!
"About 95 percent of patients regain their sight after treatment, and in some, vision gradually gets better than it was before the onset of the disease."
Sigh....another hopelessly sensationalistic headline.
A promising drug, BUT it must be understood that the "95 percent of patients who regain their sight" are from a very narrow group, selected for their chance to succeed. Throwing this drug at every patient with exudative maculopathy (wet AMD), would result in a much lower success rate.
Like any treatment, this drug's success hinges largely on the stage of the disease, the exact mechanism of tissue destruction and accompanying conditions.
Signed, a frustrated with not being able to read fine print, over 50 person
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