What is Visudyne?
Visudyne is a medicine 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 abnormal growth of blood vessels under the macula, the central part of the retina (the light-sensitive membrane at the back of the eye).Bleeding or leaking of fluid from these blood vessels causes vision loss.
Visudyne is indicated in the treatment of two diseases with these characteristics, namely the wet (or wet) form of age-related macular degeneration (AMD) and pathological myopia, a rare form of myopia in which the eyeball continues to grow, elongating more. than due. In wet AMD, Visudyne is indicated when the 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. The treatment with Visudyne is a two-step process: the first step is the administration of 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 15 minutes after 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 from a laser) to activate a photosensitizing substance. When Visudyne is given to the patient, verteporfin is distributed throughout the body through the blood vessels, including the vessels that supply the back of the eye. When the laser light is directed into the eye, verteporfin is activated and becomes cytotoxic (ie capable of destroying cells). This helps to close the abnormal blood vessels that cause AMD.
How has Visudyne been studied?
Visudyne has been studied in two two-year studies involving 609 AMD patients with classic subfoveal lesions, in which it was compared with placebo (a substance that has no effect on the body). Among patients who completed the studies, 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 neovascularisation caused by pathological myopia. Among them, 67 patients continued treatment for up to 5 years. All studies compared the efficacy of Visudyne with that of a placebo. The main measure of efficacy 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 on scanning), as part of a 2-year study involving 339 patients. it was followed by a confirmatory study in an additional 364 patients, carried out at the request of the CHMP.
What benefit has Visudyne shown during the studies?
In the two studies involving patients with classical subfoveal choroidal neovascularization, Visudyne was more effective than placebo. After 12 months, the proportion of patients who responded to treatment was 61% in subjects treated with Visudyne and 46% in those treated with placebo. The benefit was maintained for up to 5 years.
In patients with neovascularisation caused by pathological myopia, vision loss of less than 15 letters was observed in 86% of subjects treated with Visudyne and 67% of those treated with placebo after 12 months of treatment. at 5 years.
While the first study related to occult disease showed some 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 between 1 and 10 patients in 100) are abnormal vision (blurring, clouding, blurred vision, flashes of light, decreased visual acuity, gray or dark halos and black spots), site reactions d "injection (pain, swelling and inflammation) and pains seen during the infusion such as back pain, nausea, photosensitivity reactions (burns of the skin exposed to light), asthenia (weakness) and hypercholesterolemia (high blood cholesterol) For the full list of side effects reported with Visudyne, see the Package Leaflet.
Visudyne must not be used in people who may be hypersensitive (allergic) to verteporfin or any of the other substances, in patients with porphyria (inability to break down chemicals called 'porphyrins') or in people with severe liver failure.
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 neovascularisation secondary to exudative age-related macular degeneration, when the lesions are predominantly classical, or secondary. at pathological myopia. The Committee therefore recommended the granting of a marketing authorization for Visudyne.
Other information about Visudyne:
On 27 July 2000, the European Commission granted Novartis Europharm Limited a "Marketing Authorization" for Visudyne, valid throughout the European Union. The "Marketing Authorization" was renewed on 27 July 2005.
For the full version of the Visudyne EPAR click here.
Last update of this summary: 05-2007
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