Metvixia and Aktilite CL128 approved by FDA
Photocure ASA announces that Metvixia(TM) in combination with Aktilite® CL128, the LED based narrow band (630 nm) red light technology device has been approved by US food and Drug Administration (FDA) for the treatment of actinic keratosis (AK), a pre-cancerous skin lesion.
The supplement to the NDA for Metvixia (Metvixia(TM) is the US trade name) submitted 28 June 2007, comprised documentation on the new medical device Aktilite CL128 developed by Photocure as well as data from two new pivotal and three supportive phase 3 studies to document the efficacy of Metvixia in combination with Aktilite CL 128. In the pivotal studies 211 patients with multiple AKs in face or scalp were treated with Metvixia Cream or placebo prior to illumination with Aktilite. Both studies showed significantly better response with Metvixia compared to placebo at 3 months after treatment. The results confirmed the excellent results seen in earlier phase 3 studies with Metvixia photodynamic therapy (PDT).
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