New indication granted for Flexible Cystoscopes based on results of phase III trials.

The FDA has approved Photocure ASA’s supplemental new drug application (sNDA), which extends the indication for Blue Light Cystoscopy (BLC™) with Cysview® to include Flexible Cystoscopes. Flexible Cystoscopes are used for the surveillance of patients who have bladder cancer. This is currently the only combination of a drug and a device to be approved for the detection of bladder cancer.

This approval was based on the results of a phase III trial that employed KARL STORZ blue light enabled rigid and flexible cystoscopes. In the study, it was found that BLC™ significantly (p<0.0001) improves detection of bladder cancer in patients with recurrent occurrences of the cancer. The indication includes the combination of Cysview with the KARL STORZ PDD Flexible Blue Light Videoscope System and 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.

Gary Steinberg, M.D., The Bruce and Beth White Family Professor, Vice Chairman and Director of Urologic Oncology, University of Chicago Medicine, explained the gravity of the approval. “This expanded approval in both rigid and flexible blue light cystoscopy (BLC) means that Cysview can now be used during transurethral resection of bladder cancer surgery for diagnosis and staging, as well as with follow-up surveillance of non-muscle invasive bladder cancer (NMIBC). Patients with NMIBC, especially NMIBC, require careful and frequent follow-up due to the high rate of recurrence and progression. Blue light cystoscopy with Cysview will enable physicians to provide appropriate and more accurate treatment earlier, which in my experience results in improved outcomes for my patients. In my high-risk NMIBC clinical practice, I recognize the benefit of using BLC with Cysview to more readily detect carcinoma in-situ, i.e. aggressive high-grade flat lesions. In this study, an additional 35% of CIS patients were found by using BLC with Cysview alone and missed with white light," he said. 

Photocure, is headquartered in Oslo Norway, and specializes in urology. Hexvix®/Cysview® is taken up by cancer cells in the bladder, selectively and turns these cells bright pink during Blue Light Cystoscopy (BLCTM). According to the company, “BLCTM with Hexvix® /Cysview® improves the detection of tumors and leads to more complete resection, less residual tumors and better management decisions.”