AUA 2017: Positive data from Phase 3 US Blue Light Cystoscopy with Cysview® 

Boston, MA (UroToday.com) Photocure Inc., announced that new Phase 3 study results with Blue Light Flexible Cystoscopy (BLFC™) with Hexvix®/Cysview®* were presented during a late-breaking plenary session at the American Urological Association (AUA) Annual Meeting in Boston, Massachusetts on Sunday May 14th. The study showed that BLFC with Cysview detected bladder cancer recurrence in 21.5% of the patients undergoing surveillance cystoscopy that otherwise would have been missed with white light (WL) alone, which is highly significant (p<0.0001).

Of note, the study showed that nine out of twenty-six patients (34.6%) with flat, more aggressive high grade lesions (carcinoma in situ; CIS) were diagnosed using confirmatory Blue Light Cystoscopy with Cysview alone and not WL (p<0.0001). The study also showed that there was no increase in the rate of related adverse events after repeated administration of Cysview in bladder cancer patients undergoing cystoscopy examination.

The study was a prospective, open, comparative, within-patient controlled study, included 304 patients with non-muscle invasive bladder cancer (NMIBC) enrolled at 17 academic institutions in the US. In the study BLFC with Cysview was used with the KARL STORZ D-LIGHT C PDD Flexible Videoscope System.

“This study shows that BLFC can provide a significant advantage for patients in terms of early detection of tumor recurrence which may improve treatment and therefore lead to better outcomes,” says one of the lead investigators J. Stephen Jones, MD, president of Cleveland Clinic Regional Hospitals and Family Health Centers. “92.7% of the patients said it was worthwhile to undergo BLFC and 93.8% said that they would do it again. The results of the study show that BLFC will play a significant role in outpatient management of bladder cancer.” 

 “We are very pleased with the strong results of this Phase 3 study and intend to submit the data to the US Food and Drug Administration (FDA) to seek approval of BLFC with Cysview® in the surveillance setting in the US, and an expansion of the indication to include CIS,” says Ambaw Bellete, President, Photocure Inc. “We are committed to working with the FDA to bring this important tool to the US market so that physicians and patients can benefit from potentially better and more cost-effective management of the disease.”  

Click here for a link to the late breaking abstract: http://bit.ly/BLFCC-LateBreaking.

In addition, on May 12th at the AUA annual meeting, data from the largest Bladder Cancer Registry Study in the US was presented at a Poster session “Blue Light Cystoscopy for the diagnosis of Urothelial Bladder Cancer: Results From a Prospective Multicenter Registry.” The results from 9 centers included 1325 lesions, from 517 procedures in 426 patients. The conclusion of the study was that BLC significantly increased the detection of CIS and papillary lesions over WLC alone and can result in upstaging and upgrading in about 13% of patients, which can affect patient outcomes.