Novartis Ophthalmics, the eye health unit of Novartis AG, and QLT Inc. announced that the Committee for Proprietary Medicinal Products (CPMP) of the European Medicines Evaluation Agency (EMEA), has adopted a positive opinion on Visudyne (verteporfin) therapy to also include the treatment of patients with evidence of recent or ongoing disease progression in occult subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD), a leading cause of blindness among people over the age of 50. The CPMP opinion will now be considered by the European Commission, which should make a final decision within three months regarding marketing authorization in the European Union.
Visudyne therapy is the only drug approved for the treatment of certain forms of wet AMD. AMD consists of two forms: wet and dry. Although only 15 per cent of AMD patients suffer from the wet form of the disease this type is more aggressive and accounts for approximately 90 per cent of severe vision loss. Approximately 500,000 new cases of the wet form of AMD occur each year worldwide, and this estimate is expected to grow dramatically as the population ages.
AMD is caused by a growth of abnormal blood vessels (CNV) under the central part of the retina or macula and occurs in two forms, dry and wet AMD. In the wet form, the vessels leak fluid and blood that lead to the development of scar tissue that destroys the central retina. This results in a deterioration of sight over a period of two months to three years. "Occult" and "classic" are terms used to describe the different patterns of CNV leakage as seen on fluorescein angiography.
"We look forward to the European Commission's final decision and to being able to provide Visudyne to the many patients for whom there is no approved drug treatment currently available," said Paul Hastings, president and CEO of QLT.
This application was based on favorable two-year results from the Verteporfin in Photodynamic Study trial (VIP), a phase IIIb clinical trial, which included 258 patients with subfoveal occult without classic CNV, who had recent disease progression. The study showed that patients who received Visudyne therapy for 24 months had a significantly reduced risk of moderate and severe vision loss compared to the placebo group. The results were published in the May 2001 issue of the peer-reviewed American Journal of Ophthalmology.
"We are very pleased with the committee's recommendation for approval of Visudyne for occult wet AMD, " said Luzi von Bidder, head of Novartis Ophthalmics. "This positive recommendation is a very important milestone as occult CNV represents a considerable portion of the total wet AMD population and if approved this indication could expand the current market for Visudyne to two-thirds of the total patient population in Europe."
Visudyne therapy has treated approximately 150,000 patients worldwide. Visudyne is commercially available in 62 countries for the treatment of predominantly classic subfoveal CNV caused by AMD. It is also approved in 40 countries, including the EU, U.S. and Canada, for the treatment of subfoveal CNV due to pathologic myopia (severe near-sightedness). In the U.S., Visudyne has received an additional approval for CNV due to presumed ocular histoplasmosis.
Visudyne therapy, developed by Novartis Ophthalmics and QLT Inc., is a relatively painless two-step procedure performed in a doctor's office. Visudyne is injected intravenously into the patient's arm, and then a non-thermal laser light is shone into the patient's eye to activate the treatment. Visudyne targets the abnormal blood vessels and does not affect normal/healthy blood vessels.
Visudyne is generally well tolerated and has an excellent safety profile. Potential side effects include injection site reactions, headaches, back pain, blurring, decreased sharpness and gaps in vision, and in 1-5% of patients a substantial decrease in vision with partial recovery in some patients. People should avoid direct sunlight for five days to avoid sunburn. People with porphyria should not be treated.