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European regulators considering dropping Visudyne's approved indications for AMD-related CNV
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VANCOUVER, British Columbia — The Committee for Medicinal Products for Human Use informed QLT that it will recommend to the European Commission that occult subfoveal choroidal neovascularization secondary to age-related macular degeneration be removed from the list of approved indications for treatment with Visudyne photodynamic therapy, QLT announced in a press release.
The European Commission is expected to endorse the committee's recommendation when it issues its final decision, which is expected to be released within 2 months. Such a decision is not expected to affect Visudyne's (verteporfin) other indications for treating predominately classic or pathologic myopia, according to the release.
The committee based its recommendation on a review of data from the Visudyne in Occult trial, which did not meet its primary endpoints. QLT had conducted that study in part due to a request by the committee to confirm results of the Visudyne In Photodynamic Therapy study, which found evidence of efficacy for treating patients with occult disease and served as the basis for Visudyne's initial European marketing authorization, according to the release.
It is not clear how the decision would affect European Visudyne sales, the release said.