Canadian biopharmaceutical firm QLT says that the European Medicnies Agency's Committee for Medicinal Products for Human Use (CHMP) will recommend that approval for the use of Visudyne (verteporfin) in the treatment of occult subfoveal chorodial neovascularization (CNV) associated with age-related macular degeneration be withdrawn.
The CHMP opinion is based on data from the VIO trial, which revealed that treatment did not bring about a statistically-significant improvement in the condition, despite previous study results indicating that it may be of therapeutic benefit.
The product, which was developed in partnership with Swiss drug major Novartis, will still be approved as a therapy for AMD in Europe. QLT said that it is unclear how the CHMP's recommendation will affect sales, but added that the outcome will largely depend on the extent to which countries in the region changes their reimbursement policies regarding Vidudyne.
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