Oslo, Norway, 2 April 2003.
PhotoCure has received formal approval in Australia of its marketing authorisation application (MAA) for the treatment of actinic keratosis (AK, an early form of skin cancer). Formal approval was issued by the Therapeutic Goods Administration (TGA) today following a recommendation by the Australian Drug Evaluation Committee (ADEC) in February 2003.
With the highest frequency of sun-induced skin diseases in the world, Australia constitutes a very important market for Metvix® PDT. The approval is therefore a major milestone for PhotoCure. In September 2002, PhotoCure submitted additional clinical data to the TGA for Metvix® PDT in the treatment of basal cell carcinoma (BCC). This application is still pending.