What is Visudyne?
Visudyne is a drug containing the active substance verteporfin, available in a vial as a powder for solution for infusion.
What is Visudyne used for?
Visudyne is indicated for the treatment of patients with subfoveal choroidal neovascularization, a disease in which there is an abnormal growth of blood vessels under the macula, the central part of the retina (the light-sensitive membrane located at the back of the eye). Bleeding or leaking fluid from these blood vessels causes vision loss.
Visudyne is indicated in the treatment of two diseases with these characteristics, namely the exudative (or moist) form of age-related macular degeneration (AMD) and pathological myopia, a rare form of myopia in which the eyeball continues to grow, becoming longer of the due. In exudative AMD, Visudyne is indicated when neovascularization is "predominantly classical" (ie when the affected blood vessels appear well defined on scanning).
The medicine can only be obtained with a prescription.
How is Visudyne used?
Visudyne should only be used by ophthalmologists experienced in the treatment of patients with age-related macular degeneration or pathological myopia. Treatment with Visudyne is a two-step process: the first step is to administer Visudyne with an intravenous infusion (drip into a vein) lasting 10 minutes at a dose of 6 mg / m2 of body surface ; the second phase involves the activation of Visudyne in the eye at a distance of 15 minutes from the start of the infusion, using the light generated by the laser. If necessary, the treatment can be repeated every three months.
How does Visudyne work?
The active ingredient contained in Visudyne, verteporfin, is a photosensitizing agent (a substance that changes when exposed to light) used in "photodynamic therapy", ie a treatment method that uses light (usually a laser) to activate a photosensitizing substance. When Visudyne is administered to the patient, verteporfin is distributed throughout the body through the blood vessels, including the vessels supplying the back of the eye. When laser light is directed into the eye, verteporfin is activated and becomes cytotoxic (ie able to destroy cells). In this way it helps to close the abnormal blood vessels that cause AMD.
How has Visudyne been studied?
Visudyne has been analyzed in two two-year studies conducted on 609 patients with AMD with classic subfoveal lesions, in which it was compared with placebo (a substance without effects on the organism). Among the patients who completed the studies, the treatment was continued for a longer period, up to 5 years, in 476 subjects.
Visudyne has also been studied for two years in 120 patients with subfoveal choroidal neovascularization caused by pathological myopia. Of these, 67 patients continued treatment for up to 5 years. All the studies compared the effectiveness of Visudyne with that of a placebo. The main measure of effectiveness was the percentage of patients who responded to treatment after one year (the percentage of patients who had lost less than 3 lines [15 letters] on the orthoptic table).
Visudyne was finally compared with placebo in "occult" subfoveal choroidal neovascularization (in which the affected blood vessels are not well defined at the scan), as part of a 2-year study involving 339 patients. The latter study was followed by a confirmatory study on 364 other patients, carried out at the request of the CHMP.
What benefit has Visudyne shown during the studies?
In the two studies concerning patients with classical subfoveal choroidal neovascularization, Visudyne was more effective than placebo. After 12 months, the percentage of patients who responded to treatment was 61% in the subjects treated with Visudyne and 46% in those treated with placebo. The benefit was maintained for up to 5 years.
In patients with neovascularization caused by pathological myopia, a loss of vision of less than 15 letters was observed after 86 months of treatment in 86% of subjects treated with Visudyne and 67% of those treated with placebo. The benefit was maintained for up to 5 years.
If the first study related to occult disease showed a certain efficacy, this positive result was not confirmed in the second study; consequently, the benefit of Visudyne in occult subfoveal choroidal neovascularization has not been demonstrated.
What is the risk associated with Visudyne?
The most common side effects with Visudyne (seen in between 1 and 10 patients in 100) are abnormal vision (blurred, blurred, blurred vision, flashes of light, reduced visual acuity, gray or dark halos and black spots), site reactions of injection (pain, swelling and inflammation) and pains observed during infusion such as back pain, nausea, photosensitivity reactions (burns of skin exposed to light), asthenia (weakness) and hypercholesterolemia (high rate of cholesterol in the blood) . For the full list of all side effects reported with Visudyne, see the Package Leaflet.
Visudyne should not be used in people who may be hypersensitive (allergic) to verteporfin or any of the other substances, to patients with porphyria (inability to break down chemicals called "porphyrins") or to patients with severe hepatic impairment.
Why has Visudyne been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Visudyne's benefits are greater than its risks for the treatment of patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration, when the lesions are predominantly classical, or secondary at pathological myopia. The Committee therefore recommended that Visudyne be given marketing authorization.
More information on Visudyne:
On 27 July 2000, the European Commission granted a marketing authorization valid for Visudyne, valid throughout the European Union, to Novartis Europharm Limited. The marketing authorization was renewed on 27 July 2005.
The full EPAR for Visudyne can be found here.
Last update of this summary: 05-2007
