Photocure finalises two phase III studies on Metvix® PDT/Aktilite
Photocure has finalised two multicenter phase III studies comparing Metvix PDT to placebo using Photocure's light source Aktilite at leading clinical centres in the EU/US. The studies were conducted to obtain approval for Metvix in combination with Aktilite in the US (the trade name in the US is Metvixia(TM)).
The studies were conducted in 12 centres in the US and 8 centres in Germany. The two studies included 96 and 115 patients with 4-10 actinic keratosis (AK) lesions of grade 1 or 2 in the face or scalp. Metvix cream or placebo cream was applied for 3 hours prior to illumination with Aktilite. All patients received two treatments with one week apart, and were followed for 3 months.
Both studies showed significant better response in patients treated with Metvix than the one in the placebo group. These results are similar to the excellent results seen in earlier clinical studies with Metvix in combination with Curelight.
Kjetil Hestdal, President and CEO of Photocure comments: "These two studies will be the basis for submitting the supplemental New Drug Application (sNDA) for the Aktilite lamp in the US. Both studies are conclusive and confirmatory, and we have a good scientific foundation for our application."
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