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THE MAGNIFIER - Electronic Edition
Issue #4, April 14, 2000
Produced by: Macular Degeneration Foundation
P.O. Box 9752, San Jose, CA 95157
http://www.eyesight.org
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Foundation Advisory on Visudyne
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The FDA today
approved the use of the Visudyne blood-vessel-blocking photoreactive dye and companion laser system for the treatment of select patients with certain types of the advanced or wet form of the disease.
The treatment
essentially uses a laser-light-activated dye to seal off abnormal, fragile, leaky blood vessels that grow into the macular area threatening to burst and bleed causing severe central vision loss.
The treatment offered modest
benefits with 60 percent having stable vision over a year in the treated group versus 45 percent in the group whom had nothing done to their eyes. It is important to realize that this treatment is targeted for use in specific
individuals who have the classic form of the disease.
The goal of Visudyn therapy is to slow the loss of vision in people who are at risk of losing more due to abnormal blood vessel bleeding. Visudyn therapy does not restore
vision and it has not been shown to improve vision.
Please note that only your ophthalmologist can make a proper evaluation as to whether any specific individual would be a good candidate for this therapy.
Further details follow in this press release:
Thousands of older Americans developing a creeping form of blindness called macular degeneration have a new drug to help slow vision loss, after the FDA late Wednesday approved
Visudyne. Visudyne, made by Canada's QLT PhotoTherapeutics, is a light-activated drug that can't restore already-lost vision, but in clinical trials, it helped a modest number of patients preserve some of the sight they had left.
"It's not a cure," and it's not for everybody with macular degeneration, stressed Neil Bressler, MD, of Johns Hopkins University, who helped test Visudyne. But "it definitely reduces their chance of vision
loss."
Age-related macular degeneration, or AMD, is a leading cause of blindness among older Americans. It tends to affect people over 50, stealing sight from the center of the eye out.
The macula is the
light-sensitive layer of tissue in the center of the retina. Two types of AMD destroy it:
'Dry' AMD, which accounts for 90 percent of cases, slowly breaks down the macula's light-sensitive cells. There is no treatment. But
the damage occurs very slowly so victims only gradually notice a blind spot in their central vision and do not completely lose sight.
'Wet' AMD is rarer but much worse. New blood vessels form behind the retina, leaking onto
the macula and rapidly destroying it. First, straight lines appear wavy. Fine detail fades. Readers can't focus on just one word and people's faces start to blur. People gradually lose the ability to read or drive and often
progress to blindness within two years.
Visudyne is for wet AMD cases only.
Visudyne is light-activated. The drug is injected into the arm and then migrates into the abnormal blood vessels that destroy sight. Shine
in a non-burning beam of light and the drug is activated, preventing the growth of those blood vessels without hurting surrounding tissue.
In one study, 61 percent of Visudyne patients had stable vision after a year of
therapy, compared with 45 percent of patients given a placebo. That sounds modest, but Bressler called it important: "It's more likely they can do some reading with magnification aids, tell the difference between a
dollar bill and a $20 bill, tell ... who they're looking at." He estimated that of the 200,000 new AMD cases a year, about 30 percent of patients could qualify for Visudyne.
There is one other treatment, a
powerful laser that cauterizes the blood vessels. But only 15% of patients qualify, because if the blood vessels are in the wrong spot, the laser can hurt more than it helps, resulting in permanent blindness in areas used.
Patients undergoing Visudyne treatment are advised to avoid direct sunlight for several days. As of the FDA approval announcement, QLT was ready to ship Visudyne to ophthalmologists' offices immediately and said the treatment costs
about $2,000 per treatment. Over a period of two years, patients on average get five treatments, a number that varies according to how much blood vessel growth they have.
Medicare is expected to cover most of the cost for
elderly patients because the drug is given during an in-office procedure.
Support Needed for Efforts to Develop Broad Ranging Therapies for all Forms of MD
The Macular Degeneration Foundation is dedicated to driving
development of therapies that prevent and treat all forms of the disease, dry and wet. You too can join the fight to save sight. We are on the verge of important research initiatives that hold great promise for improved
therapies and even a cure. Please consider a tax deductible contribution to enable much-needed research to get under way and to help millions more learn about the disease before its too late. You can make that difference and give
the great gift of vision to your family members, friends and loved ones.
Please send your contribution to:
Macular Degeneration Foundation
P.O. Box 9752
San Jose, CA 95157
About the Macular Degeneration Foundation
Founded and supported by people with macular degeneration and their friends and families from all over the world, the Macular Degeneration Foundation (MDF) is dedicated to programs
that help prevent and aim to assist and heal the over 15 million victims of this debilitating disease. Its web site www.eyesight.org is presently the number one Internet destination for news, support and information about the
disease.
The Foundation is dedicated to pursuing potential approaches that could deliver sight-saving solutions for macular degeneration sooner and more cost-effectively.
The Foundation devotes its resources towards supporting three program areas
Research
Designing and directing better, faster and more cost-effective research towards real solutions
Education
Improving
public, patient and professional education to enhance awareness and action towards prevention and cure
Patient and Professional Support Services
Helping patients connect to professionals conducting research and
building peer-support networks nationwide
The MDF structures, supervises and supports carefully targeted, rigorous research by some of the nation's top physicians and researchers in the field of macular degeneration. The
research is directed towards five principal objectives encompassing focused basic and applied science projects.
First, to emphasize our near-term results-oriented focus we have structured research into optimal vision rescue
and restoration approaches. This research includes programs to test new laser technologies that show promise in stimulating dissolution of vision-diminishing drusen deposits. This program raises funds to support a nationwide
recruitment and enrollment campaign of carefully selected patients that match required criteria for research. This crucial task helps accelerate the critical time-to-study-start that is the most significant factor slowing the
discovery process. This program includes support for patient care and epidemiologists charged with the structured collection and analysis of data and the coordination and compilation of reports on progress from all centers. Past
projects in this category include vital educational support for the Women's Health Initiative-Sight Exam Study - the US single largest nationwide clinical trial for macular degeneration, conducted by the National Institutes of
Health. The Foundation's support was featured on television news programs in over 50 US metropolitan areas.
Second, since so little is known about the natural history of macular degeneration we have committed ourselves to
helping collect the first comprehensive national database of critical variables that can shine a light on the many aspects of this perplexing disease.
Third, since it is critically important that we understand the biology of
normal macular function so that we can better appreciate what goes wrong in the various forms of macular degeneration, we are committed to funding targeted basic macular biology projects within laboratories at Harvard University,
with priorities set by Prof. Robert D'Amato, M.D., Ph.D.
Fourth, we seek to better understand the emerging role that abnormal genes play in producing this disease. Research supported by the Foundation has recently identified
a promising cluster of genes that could hold important clues to disease causation and progression. We are committed to raising funds to expand this research to reveal ways in which the specific identified genetic flaws can be
effectively treated.
Fifth, we will synthesize this knowledge by developing a dynamic model of potential mechanisms via which macular degeneration occurs. Unlike other areas of medicine, scientists studying macular
degeneration are still struggling to find the resources to support development of an appropriate and accurate disease model.
Your support will assist MDF in accelerating its research programs and help save the sight of
millions of Americans. Support is appropriately acknowledged and rewarded with a tax deduction to the full extent of the law.
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The MAGNIFIER is distributed without charge.
We hope that it will continue to serve the interests of its subscribers. Contributions to Macular Degeneration Foundation are appreciated and may be sent to P.O. Box 9752, San Jose, CA 95157
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Disclaimer: The above information does not constitute medical advice. Only your physician or licensed ophthalmologist can dispense medical advice based upon a complete and thorough evaluation of
your specific and unique situation.
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