Visudyne Photodynamic Therapy |
| AMD and Visudyne Therapy Key Messages and Facts |
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| Visudyne therapy has now been approved by the FDA
Visudyne therapy is the first approved drug treatment for wet AMD
Visudyne therapy reduces the risk of vision loss from wet AMD
AMD is a leading public health concern. AMD is the leading cause of vision loss in patients over age 50 in the Western World.
AMD is not a well-known disease
Early detection is the key to reducing the risk of vision loss from AMD
Visudyne Care
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| Frequently Asked Questions About Visudyne Therapy and AMD |
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What is wet AMD?
How does the therapy work?
How many people are affected by AMD?
Can the therapy restore lost vision?
Doesn't the laser damage the eye?
What data supports Visudyne therapy's efficacy?
Are there any other clinical trials planned for Visudyne therapy?
Who makes Visudyne therapy?
Is there a web site where I can learn more about Visudyne therapy?
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| Visudyne therapy has now been approved by the FDA |
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| Visudyne therapy was recently approved by the U.S. FDA as a treatment for the more severe or wet form of AMD, the leading cause of blindness in people
age 50 and older. Specifically, Visudyne is indicated for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization. |
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| Visudyne therapy is the first approved drug treatment for wet AMD |
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Visudyne therapy is a major medical breakthrough offering hope to those with wet AMD.
The only approved treatment prior to Visudyne therapy was laser photocoagulation, which involves the use of a high-powered thermal laser that can damage or destroy overlying retina tissue. Only 10-20% of patients with wet AMD were candidates for laser photocoagulation.
Approximately 40-60% of patients with wet AMD could be candidates for
Visudyne therapy. |
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| Visudyne
therapy reduces the risk of vision loss from wet AMD |
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In controlled studies at 12 months, 67% of patients treated with Visudyne lost less than 15 letters of visual acuity (3 lines of vision)
compared to 39% of patients treated with placebo.
Patients typically require continued evaluation and periodic retreatment at 3 month intervals for at least 2 years.
Visudyne therapy does not restore vision in eyes that have suffered longstanding vision loss or have been significantly damaged by AMD.
Visudyne therapy was co-developed by Ciba Vision Corporation, the eye care unit of
Novartis AG, and QLT PhotoTherapeutics, Inc. |
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| AMD is a leading public health concern. AMD is the leading cause of vision loss
in patients over age 50 in the Western World. |
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Approximately 25-50 million people over the age of 50 are affected by AMD, and an estimated 500,000 new cases of wet AMD are reported worldwide
each year.
More than one million people over the age of 55 suffer from wet AMD in the U.S., and over 200,000 new cases of wet AMD are reported each year.
Wet AMD is a devastating condition that causes the loss of central vision in as little as a few months to 3 years. With the loss of central vision, patients can no longer read, drive, watch television or see the faces of loved ones.
Wet AMD occurs when blood vessels in the center of the retina grow abnormally. The abnormal blood vessels leak fluid and blood, which causes scarring of the retina and can lead to
permanent vision loss.
Wet AMD accounts for only about 15% of all macular degeneration cases, but it leads to 90% of the severe
vision loss associated with the disease. |
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| AMD is not a well-known disease |
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| Despite the seriousness of AMD and the high incidence rate, a recent survey has shown that almost 97% of Americans are unaware that AMD is the leading cause of vision
loss in people over age 50. Further, approximately 70% were not familiar with the condition at all. |
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| Early detection is the key to reducing the risk of vision loss from AMD |
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The American Academy of Ophthalmology recommends that all patients be seen by their eye care professional every 2 years. Older patients or patients with higher risk of
AMD should be screened more frequently.
If you notice any visual disturbances, such as straight lines appearing wavy, consult your eye care professional immediately. |
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| Visudyne Care |
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- You'll probably need more than one treatment.
- You must avoid sunlight and bright, artificial light (e.g., halogen lighting) for at least 48 hours, and
preferably for five days.
- Avoid dental procedures and surgery during this time, because they use bright lighting.
- Stay indoors. If you must go outdoors, cover every bit of skin and wear a hat and very dark sunglasses.
- Remember that sunscreen lotion won't help, because it blocks out ultraviolet light and the drug makes you sensitive to infrared light.
- ...But don't shut yourself up in the dark. Ambient indoor lighting actually helps inactivate the drug in the skin.
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| Back to top |
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Frequently
Asked Questions About Visudyne Therapy and AMD |
| What is Visudyne therapy? |
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| The U.S. Food and Drug Administration (FDA) recently approved Visudyne therapy for treatment of patients who have an aggressive form of wet AMD called predominantly classic subfoveal choroidal neovascularization (CNV). |
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| What is wet AMD? |
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| Wet AMD destroys central vision, which is necessary for reading, driving and the recognition of faces. It is caused by the growth of abnormal, leaky blood vessels in the eye,
beneath the center of the retina.
These vessels leak fluid and eventually cause scar tissue, destroying central vision. Vision loss can progress in wet AMD patients in as little as two months to three years. |
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| How does Visudyne therapy work? |
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| Visudyne therapy is a two-step procedure that can be performed in a doctor's office. First, Visudyne, a light-sensitive drug, is injected intravenously into a patient's arm.
Visudyne is taken up by the abnormal blood vessels in the eye. Second, the drug is activated by shining a non-thermal, or "cold" laser in the patient's eye. |
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| How many people are affected by AMD? |
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| Medical experts estimate that 25 to 30 million people worldwide are affected by AMD. In addition, 200,000 people in North America and more than 500,000 people worldwide
develop wet AMD each year.
AMD is the leading cause of legal blindness in people over the age of 50. |
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| Can Visudyne therapy restore lost vision? |
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| Visudyne therapy cannot restore vision lost to AMD, but it confines the retinal damage and slows the progression of the disease. |
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| Doesn't the laser damage the eye? |
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| No. Since a non-thermal or "cold" laser is used in Visudyne therapy, normal, healthy cells and tissue are not damaged, only abnormal blood vessels. This is critical, as past
treatments have been unsuccessful in slowing the disease and have resulted in the destruction of normal
blood vessels, causing immediate vision loss. |
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| What data supports Visudyne therapy's efficacy? |
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| A clinical study published in the October 1999 issue of Archives of Ophthalmology showed that in 243 patients with predominantly classic CNV, Visudyne
therapy stabilized or improved the vision of 67 percent of those receiving the treatment. |
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| Are there any other clinical trials planned for Visudyne therapy? |
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| Additional clinical trials are being conducted to determine the effectiveness of Visudyne therapy in patients with an earlier stage of AMD, as well as in patients with
a similar but distinct condition associated with progressive near-sightedness known as pathologic myopia. Full results from these trials are
expected in the second quarter of 2000. |
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| Who makes Visudyne therapy? |
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| Visudyne therapy is being co-developed for ocular conditions by CIBA Vision Corporation, the eye care unit of Novartis AG, and QLT PhotoTherapeutics, Inc.
CIBA Vision will market the product worldwide and QLT will be responsible for manufacturing the product. |
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| Is there a web site where I can learn more about Visudyne therapy? |
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| Yes, it is located on the Internet at
www.visudyne.com. |
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