Answering Questions Frequently Asked by Patients

What is Visudyne?
Visudyne is the first drug therapy to become available for patients with a certain form of age-related macular degeneration (AMD). It is used in the treatment of patients with the type of AMD known as predominantly classic subfoveal wet AMD. The generic, or chemical, name for Visudyne is verteporfin (ver-te-POOR-fin). Only a qualified eye care professional can determine if Visudyne therapy is right for you.

Visudyne therapy has been proven to help stop or slow the abnormal growth of blood vessels in the back of the eye, due to predominantly classic subfoveal CNV secondary to AMD, pathologic myopia, or presumed ocular histoplasmosis.³ This abnormal growth of blood vessels is called choroidal neovascularization (CNV). In all cases, predominantly classic CNV is a serious condition that can quickly cause severe vision loss if left untreated.

Visudyne is given by injection and is activated by a non-heat-producing laser light. Three months after administering Visudyne, I will examine your eyes to determine the extent of changes that resulted from the therapy. If there is evidence of blood or fluid leakage, I will perform another Visudyne therapy session. We will repeat this process every 3 months until the bleeding and leakage have stopped. Even if there is no evidence of blood or fluid leakage at any one visit, we will still follow up every 3 months (or possibly at longer intervals), to be certain the leakage and bleeding have not returned.

What else do I need to know about AMD?
The most important thing is that AMD affects a person’s vision. The abnormal blood vessel growth in AMD takes place in the center of the macula, the part of the eye that provides your central vision. AMD usually occurs in people who are aged 65 or older.⁴ There are 2 types of AMD:

• Dry AMD occurs in about 90% of people who develop AMD.⁵ In this form, the vision deteriorates very slowly, if at all
• Wet AMD occurs in the remaining 10% of patients with AMD.^5,6 In this form, the abnormal new vessels leak fluid under the macula and form scar tissue that leads to vision loss. Many people with wet AMD will develop severe vision loss in 2 to 3 years.¹

There are 2 patterns of wet AMD—classic and occult. Most patients with wet AMD have a combination of classic and occult AMD. Visudyne is indicated when the patient has predominantly classic wet AMD and when the lesion is not too big or too small.

How does Visudyne work?
Visudyne is injected into the bloodstream, usually through a vein in the arm. It travels through the bloodstream to the abnormal new blood vessels associated with AMD. Shortly after the injection, I will shine a non-heat-producing laser light into your eye. This light “activates” Visudyne. Once activated, Visudyne begins a chemical process that causes the abnormal blood vessels to close. The process occurs without causing thermal (heat) damage to the healthy retina nearby.

In this manner, Visudyne can slow the progression of vision loss associated with predominantly classic wet AMD. In medical studies, after 1 and 2 years of therapy, patients who were given Visudyne had significantly less loss of vision than those who received placebo therapy.¹

What happens after the first therapy session with Visudyne?
After the initial therapy, I will examine your eyes approximately every 3 months to gauge your response to the previous therapy. Since leakage and bleeding often recur and the abnormal vessels often return with this persistent disease, we must plan to give you Visudyne therapy every 3 months, until the bleeding and leakage are no longer present.

Visudyne therapy causes the skin and eyes to temporarily become sensitive to light (photosensitivity). As a precaution, when you receive Visudyne therapy, you must avoid direct sunlight and bright lights for 5 days after treatment.

As with any therapy, you should follow the recommended safety precautions before, during, and after therapy.

How do you determine who should receive Visudyne?
Visudyne is indicated for the treatment of a specific type of abnormal blood vessels that grow in the center of the macula—the part of the eye responsible for central vision—due to age-related macular degeneration, pathologic myopia, or presumed ocular histoplasmosis. I provide Visudyne for patients who I believe are appropriate candidates for the therapy based on these indications and my experience. Also, I will NOT give you Visudyne if you have porphyria (a medical condition that causes extreme photosensitivity) or you are allergic to any of the ingredients of Visudyne.

Will Visudyne therapy hurt?
Visudyne therapy is a simple intravenous infusion into the arm followed by the application of a cool laser light to the eye. The application of light does not cause any pain in the eye. Other than the initial prick delivered by injection, patients are not likely to experience any pain. Some patients (10%-30%) have experienced side effects such as injection site reactions, back pain during infusion, and blurring, decreased sharpness, and gaps in vision.

In rare instances (1% to 5% of patients), patients receiving Visudyne have experienced a substantial decrease in vision within the first week of treatment, with some patients going on to experience partial recovery. Patients who experience substantial vision loss following Visudyne therapy should consult their healthcare professional immediately, and may require a break in therapy until the condition resolves, or they may need to discontinue therapy completely.

Is there anything special I need to do when receiving Visudyne therapy?
When preparing for your therapy, remember Visudyne therapy causes your skin and eyes to become temporarily sensitive to light. Be sure to bring the following items to your appointment:

• Sunglasses
• Gloves
• A wide-brimmed hat
• A tight-weave, long-sleeved shirt
• Slacks

After your treatment, your eyes and skin will be sensitive to bright light and direct sunlight for 5 days. You should wear a wristband to remind yourself of this photosensitivity, and follow precautions such as avoiding:

• Bright sunlight
• Tanning salons
• Halogen lighting in homes and offices, including bright halogen reading lamps
• Lighting used in a dentist’s office or surgical operating room
• Undraped windows with direct sunlight
• Skylights

Avoid exposure to direct sunlight for 5 days

• You should not stay in the dark. Exposing your skin to normal indoor light helps to remove the drug from the skin
• If possible, wait until sundown to do outside chores (such as shopping)
• Remember that UV sunscreens are not effective in protecting against photosensitivity reactions
• Enjoy yourself — relax, take it easy at home, and just be careful for the next 5 days
• After 5 days, you may resume normal outdoor activities without any special precautions

If you DO go out during daylight hours within the first 5 days, WEAR:

• Long-sleeved shirt and slacks
• Tight-weave, light-colored fabrics
• Gloves
• Socks and shoes
• Sunglasses
• Wide-brimmed hat

How often will I need Visudyne?
Visudyne is a multicourse therapy. Follow-up evaluations are recommended at 3-month intervals to determine if subsequent treatment is required. Usually several treatments are given over a period of time. In clinical trials for AMD, patients treated with Visudyne received 3.4 treatments in the first year and 2.0 treatments the second year.¹ At each 3-month visit, I will take special pictures of your eyes that will help me assess whether the abnormal vessels are sealed or leaking blood or fluid into your eye; based on that information and health considerations, I will determine whether to provide another Visudyne therapy or have you return for follow-up and possible Visudyne therapy in 3 months.

Can Visudyne be given to someone with known cardiovascular disease?
Visudyne was studied in clinical trials in which all patients were over the age of 50, many of whom had hypertension, hyperlipidemia, and/or cardiovascular disease.² While no specific comparisons were made to assess the efficacy of Visudyne in such patients, there were no significant safety problems seen amongst any patient types across the study populations—and there are no contraindications for Visudyne use in these patient types.

In trials, 1% to 10% of patients receiving Visudyne experienced atrial fibrillation, hypertension, peripheral vascular disorder, or the formation of varicose veins.

Will the laser burn my eye?
Visudyne utilizes a special, non-thermal, “cool” laser light that is shone into the eye for less than one and one half minutes. While the laser does not “burn” tissue in the eye, Visudyne therapy does cause your skin and eyes to become temporarily sensitive to bright light. As a precaution, you will need to avoid direct sunlight and bright lights for 5 days after treatment.

Be sure to bring the following items to your appointment

• Sunglasses
• Gloves
• A wide-brimmed hat
• A tight-weave, long-sleeved shirt
• Slacks

Avoid:

• Bright sunlight
• Tanning salons
• Halogen lighting in homes and offices, including bright halogen reading lamps
• Lighting used in a dentist’s office or surgical operating room
• Undraped windows with direct sunlight
• Skylights

Avoid exposure to direct sunlight for 5 days

• You should not stay in the dark. Exposing your skin to normal indoor light helps to remove the drug from the skin
• If possible, wait until sundown to do outside chores (such as shopping)
• Remember that UV sunscreens are not effective in protecting against photosensitivity reactions
• Enjoy yourself—relax, take it easy at home, and just be careful for the next 5 days
• After 5 days, you may resume normal outdoor activities without any special precautions

You should know that severe vision decrease (≥4 lines) was reported within 7 days in 1% to 5% of patients. Partial recovery occurred in some patients. These patients were not allowed to be re-treated until their vision completely recovered to pretreatment levels and the potential benefits and risks of subsequent treatment were carefully weighed.

The most frequently reported adverse events (10% to 30% incidence) were injection site reactions (including extravasation and rashes), blurred vision, decreased visual acuity, and visual field defects.

How long is Visudyne therapy?
Each Visudyne therapy session lasts about 30 minutes. When you arrive, we will dilate your pupils and then perform a few calculations in preparation for therapy. Next, a nurse will inject your arm with Visudyne, and let it travel through your body for approximately 10 minutes. After using eyedrops to numb your eye, the nurse will then place a special ophthalmologic lens over it. Once this process is complete, I will apply a cool laser light to your eye for approximately 83 seconds, which will in turn activate the Visudyne in your bloodstream.

What else do I need to know about Visudyne treatment?
If you receive Visudyne therapy, your eyes and skin will be sensitive to bright light and direct sunlight for 5 days. During this time, you should wear a wristband to remind yourself about the possibility of photosensitivity and the need to follow the precautions for things to avoid:

• Bright sunlight
• Tanning salons
• Halogen lighting in homes and offices, including bright halogen reading lamps
• Lighting used in a dentist’s office or surgical operating room
• Undraped windows with direct sunlight
• Skylights

You should not stay in the dark, however, because exposing your skin to normal indoor light helps to remove the drug from the skin. Enjoy yourself—relax, take it easy at home, and just be careful for 5 days after therapy. If possible, wait until sundown to do outside chores (such as shopping). If you do go out during daylight hours in the first 5 days, be sure to wear:

• Long-sleeved shirt and slacks
• Tight-weave, light-colored fabrics
• Gloves
• Socks and shoes
• Sunglasses
• Wide-brimmed hat

After 5 days, you can resume your normal outdoor activities without any special precautions.

What are the most frequent side effects of Visudyne?
In clinical trials, a substantial decrease in vision occurred in 1% to 5% of patients within the first week of treatment, with partial recovery in some patients. Other potential problems include injection site reactions, back pain during infusion, and visual disturbances—including blurring, decreased sharpness, and gaps in vision.