Visudyne labelling to be changed

QLT has announced that the Committee for Medicinal Products for Human Use (CHMP) will recommend to the European Commission that the occult indication for Visudyne be removed from the product's European label.

The CHMP opinion was based on its review of data from the Visudyne in Occult trial, which did not achieve the significance level required of its primary endpoints. The European Commission is expected to endorse the recommendation in a final decision to be announced in the coming months.