Photocure declares that FDA approved Blue Light Cystoscopy with Cysview

 Photocure ASA asserted that the U.S Food and Drug Administration approved its supplemental new drug application to extend the indication for Blue Light Cystoscopy with Cysview to include Flexible  Cystoscopes, which are used in the ongoing surveillance of patients with bladder cancer.

The approval of this new indication is based on the results from a large Phase 3 study using KARL STORZ blue light enabled rigid and flexible cystoscopes. This study showed that BLC significantly (p<0.0001) improves detection of patients with recurrent bladder cancer.

Kjetil Hestdal M.D. Ph.D., President & CEO said “The expanded label now allows repetitive use in the same patient which enables physicians to provide an improved continuum of care to their bladder cancer patients and should lead to reduced cost.”

Gary Steinberg, M.D., The Bruce and Beth White Family Professor, Vice Chairman and Director of Urologic Oncology, University of Chicago Medicine claimed “his 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.”