Visudyne^®
In April 2000, the Food and Drug Administration (FDA) approved Visudyne therapy as the first drug treatment for a certain form of wet age-related macular degeneration (AMD). This form of the disease is called predominantly classic wet AMD. Ask your doctor for an explanation of the different types, causes, and consequences of AMD.

In August 2001, Visudyne was also approved for the treatment of pathological myopia (a form of nearsightedness) and presumed ocular histoplasmosis (a fungal infection of the eye).

Visudyne therapy is a form of photodynamic therapy (PDT). It brings together a light-activated drug (Visudyne) and the use of a low-energy laser. The laser activates the drug in a targeted area of the eye. This produces a reaction that destroys abnormal, leaky blood vessels.

How Visudyne Works
Overview
Visudyne therapy is based on a technology called PDT that uses light-activated drugs to treat a wide range of medical conditions. Some diseases in which there are fast-growing tissues can potentially be treated with this technology.

Visudyne therapy is typically performed in a doctor's office on an outpatient basis. You will be unusually sensitive to light for 5 days following Visudyne therapy, so preparing for treatment is key. Your eyecare specialist will give you a list of instructions to follow before and after therapy to minimize the risk of complications.

What happens during treatment
First, Visudyne is injected into the bloodstream, usually through a vein in the patient's arm. The drug is quickly absorbed by the abnormal blood vessels in the back of the eye that cause sight loss in the wet form of AMD.

Second—a short time after the drug has been given—a low-energy laser is shone into the affected area of the eye for exactly 83 seconds. This activates the drug and produces a reaction that seals the abnormal blood vessels.

After treatment, the doctor will usually examine the patient's eyes every 3 months and will retreat with Visudyne, if needed, to destroy any leaking blood vessels.

There is no cure for AMD. Visudyne helps destroy existing abnormal blood vessels that can leak and damage sight. Studies have shown that patients who complete a full course of Visudyne therapy are more likely to preserve their vision than those who have no therapy. Patients and their loved ones need to have realistic expectations for therapy.

Preparing for Treatment
If you've recently been prescribed Visudyne therapy, or if a loved one has, you've probably been told there are certain instructions that need to be followed before and after therapy. They are summarized below:

Before therapy

• Bring to the treatment appointment everything that will be needed immediately after therapy, including
• a tight-knit, light-colored, long-sleeved shirt and long pants
• shoes and socks
• dark sunglasses, a wide-brimmed hat, and gloves
• Arrange for transportation well before the treatment appointment. If you typically drive, don't attempt to drive yourself home from treatment—your vision may be blurrier than usual, especially if your pupils have been dilated.
• Schedule your follow-up appointment while waiting in the reception room for treatment to avoid letting too much time lapse before your exam.

After therapy

• Wear the wristband the doctor gives you to remind yourself and let others know you have a temporary abnormal sensitivity to light.
• Avoid exposure to direct sunlight or bright indoor light, including bright halogen lighting.
• Don't stay in the dark. Exposure to normal indoor light is needed to inactivate Visudyne in the skin.
• If you must go outside during the first 5 days following therapy, wear dark, wraparound sunglasses that completely cover your eyes, and protective clothing that completely covers your skin. UV sunscreens will NOT protect you from photosensitivity reactions.
• Reschedule any elective (nonemergency) dental or surgical procedures that fall within 5 days of Visudyne treatment.
• Call your doctor immediately with any questions, concerns, or problems (such as a sudden decrease in vision, or pain at the injection site).

Click here for Prescribing Information for Visudyne to view a full list of post-therapy precautions.

Visudyne: Efficacy and Safety Results From Clinical Studies
Clinical studies have shown that Visudyne is safe and effective in helping to reduce the risk of vision loss in patients with predominantly classic wet AMD.

Studies have shown that patients who complete a full course of Visudyne therapy are more likely to preserve their vision than those who have no therapy. There is currently no therapy that will cure AMD.

Carefully following your doctor's instructions, before and after treatment, will help maximize your chances of treatment success and minimize the risk of complications.

Visudyne is a treatment to help slow the loss of vision in persons with predominantly classic wet AMD.

Important Safety Information

Visudyne therapy is not for everyone. People who have an abnormal sensitivity to light (a condition called porphyria) and those with allergies to any of the ingredients should not receive Visudyne. (Your doctor has a list of ingredients in Visudyne.) Check with your doctor or healthcare professional to see if you might be allergic to any component of Visudyne therapy. Only your doctor can determine if Visudyne is right for you.

Changes in vision, including blurring, decreased sharpness in vision, and gaps in vision are some of the most commonly reported side effects. Between 1% and 5% of patients experienced a substantial decrease in vision in the first 7 days after treatment, though some patients achieved partial recovery. Patients who experience substantial vision loss should consult their healthcare professional immediately. Injection site reactions and temporary back pain during injection were some of the most commonly reported side effects.

Patients should avoid direct sunlight or bright indoor light for 5 days following therapy with Visudyne.

Patients who have to go outdoors in daylight after treatment must protect all parts of their skin and eyes by wearing protective clothing and dark glasses. Ultraviolet (UV) sunscreens are not effective in protecting against photosensitivity reactions.

Please see full Prescribing Information.