Pharmaceutical company Photocure ASA (OSE:PHO), headquartered in Oslo Norway, revealed on Friday the receipt of US Food and Drug Administration (FDA) approval for its supplemental new drug application (sNDA) to extend the indication for Blue Light Cystoscopy (BLC) with Cysview for the detection of bladder cancer, the fifth most commonly diagnosed cancer in the US.

The company added that Cysview with the Blue Light Videoscope System is the only combination of drug and device approved for the detection of bladder cancer.

According to the company, Hexvix/Cysview is a drug that is selectively taken up by cancer cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM). BLCTM with Hexvix /Cysview improves the detection of tumors and leads to more complete resection, less residual tumors and better management decisions.

This new expanded approval of this new indication is based on the results from the company's large Phase 3 study using KARL STORZ blue light enabled rigid and flexible cystoscopes. This study showed that blue light cystoscopy (BLC) significantly improves detection of patients with recurrent bladder cancer.

Photocure also said the expanded indication includes the combination of Cysview with the Blue Light Videoscope System. The approval expands the indication in the current rigid setting (TURBT) by including the detection of carcinoma in situ (CIS) in bladder cancer patients as well as the repeated use of BLC with Cysview.