FDA approves Metvixia and Aktilite CL128 for photodynamic therapy of AK

June 27, 2008 -- Photocure ASA (Oslo, Norway) said today that the U.S. Food and Drug Administration (FDA) has approved its Metvixia cream, in combination with its Aktilite CL128 LED-based narrow band (630 nm) red light technology device, for the treatment of actinic keratosis (AK), a pre-cancerous skin lesion.

The supplement to the nondisclosure agreement for Metvixia, submitted almost exactly one year ago, 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 studies, 211 patients with multiple AKs in face or scalp were treated with Metvixia cream or a placebo prior to illumination with Aktilite. Both studies showed significantly better response with Metvixia compared to placebo three months after treatment. The results confirmed the excellent results seen in earlier phase 3 studies with Metvixia photodynamic therapy (PDT).

Metvixia PDT (known as Metvix outside of the United States and France) is approved in the EU/EEA for treatment of AK, Bowen's disease, and basal cell carcinoma. Metvix is marketed by Photocure in the Nordic region, and by Galderma in the rest of the world.

Actinic keratoses (AK) is the most common premalignant skin lesion, and affects more than 10 million Americans. It is frequently found on the hands, arms, head and other sun exposed areas. AK can develop into squamous cell carcinoma (SCC), which is an aggressive type of cancer that grows invasively into deeper layers of the skin and can spread and form metastases.

Basal cell carcinoma (BCC) is the most common malignant skin cancer. They are locally aggressive tumours that rarely metastasise (spread to other organs), but destroy surrounding tissue.

Bowen's disease (BD) is a pre-stage of SCC where the tumour has not spread, but has the potential to progress into invasive squamous cell carcinoma. It usually looks like a slow growing red, scaly patch.

Photodynamic therapy (PDT) is an effective, targeted treatment that destroys precancerous and cancer cells without harming surrounding tissue. Red light is used to activate a light sensitive substance that accumulates selectively in precancerous and cancer cells.