The FDA has granted approval for the upgraded Karl Storz blue light cystoscopy equipment to be used in combination with Photocure's Cysview (hexaminolevulinate hydrochloride) photodynamic therapy for the detection of bladder cancer. This approval marks a significant step in Photocure's plans for commercialisation of Cysview in the US and paves the way for a significant increase in market access. The launch of Cysview by Photocure's own commercial operations began in January, and the approval of the upgraded equipment will enable the placement of further blue light cystoscopes in urology centres across the US.
Cysview was approved for use in combination with the blue light cystoscopy equipment (Karl Storz D-Light C PDD system) in May 2010. After the initial approval, an upgrade to enhance the blue light system, which corresponds to the version on the market in Europe, was filed to the FDA by Karl Storz Endoscopy America.
Cysview (also called Hexvix) is described as the first approved drug-device procedure for improved detection of bladder cancer. It is designed to induce fluorescence in the malignant cells in the bladder during a cystoscopic procedure, making it easier for the urologist to detect non-muscle invasive bladder cancer, as an adjunct to white light cystoscopy. The product is used in combination with a blue light cystoscopy system, and is the first product in a new diagnostic class known as photodynamic diagnostic (PDD) agents.