Expert consensus on the optimal use of Cysview® Blue-Light Cystoscopy published in Nature Reviews Urology

Cysview® improves detection of Non-Muscle Invasive Bladder Cancer (NMIBC) beyond that achieved with current standard of care.

Oslo, Norway, 23 September 2014:  Photocure ASA (OSE: PHO), a specialty pharmaceutical company focused on photodynamic technologies in dermatology and cancer, is pleased to note that an expert consensus statement[1] on the optimal use of Blue Light Cystoscopy with Cysview (HAL-BLC) in the United States has been published in Nature Reviews Urology. (http://www.nature.com/nrurol/journal/vaop/ncurrent/abs/nrurol.2014.245.html)

Blue Light Cystoscopy with Cysview is an advancement in detection and management of Non-Muscle Invasive Bladder Cancer (NMIBC) and is becoming standard of care in many large institutions across the United States due to the advantageous clinical benefit/risk ratio. Hexvix/Cysview has been used in 250 000 procedures to date, with consistent evidence that it improves detection and management compared to White Light Cystoscopy (WLC) alone.

An expert panel of 16 American board certified Urologists and 1 European Urologist reviewed existing published clinical evidence supporting the use of Blue Light Cystoscopy with Cysview (HAL-BLC) for patients with NMIBC, including European recommendations for its use and provided their own expert opinion on which patients should receive HAL-BLC.

The panel proposed that the use of HAL-BLC in appropriate patient types will result in better disease management, leading to potential reduced risk of recurrence and prolonged time to recurrence. Improved detection and reduced risk of recurrence is in turn associated with lower overall costs in managing bladder cancer compared to WLC.

Dr. Sia Daneshmand, Director of Urologic Oncology and Associate Professor of Urology at Institute of Urology, Norris Comprehensive Cancer Center at University of Southern California and lead author, stated: “The consensus panel recommendation outlines how urologists should incorporate HAL-BLC into their clinical practice for the management of bladder cancer and the appropriate patient types that would benefit from the technology. HAL-BLC results in a more complete transurethral resection of bladder tumors (TURBT) and more accurate staging, resulting in more appropriate management decisions.  The evidence shows not only reduced risk of recurrence but also prolonged time to recurrence.”

Kjetil Hestdal, President and CEO of Photocure, said: “Bladder cancer affects 550,000 people in the U.S., with 74,690 newly diagnosed patients every year.  Approximately 15,580 patients die from the disease each year due to of recurrence of the cancer.  The consensus statement clearly outlines the benefits of Blue Light Cystoscopy with Cysview and its positive impact on the diagnosis and management of bladder cancer in multiple patient types. We believe the adoption of HAL-BLC will bring significant benefit to urologists, patients and payers fighting the disease.”

The panel members also discussed key factors that must be considered for incorporation of HAL-BLC into routine clinical practice in the United States, including economic considerations and identification of stakeholders.

The consensus panel recommended that HAL-BLC should be considered

  • For initial diagnosis of NMIBC
  • For detection of recurrent tumors
  • In patients with positive urine cytology but negative white light cystoscopy (WLC) findings
  • For optimal tumor staging

The panel concluded that extensive evidence and clinical experience show that HAL-BLC can improve the detection of NMIBC beyond that achieved with the current standard of care, WLC.

The consensus opinion of the US expert panel is in line with the opinions of European colleagues, namely that HAL–BLC has a role in the initial diagnosis of patients suspected to have NMIBC, as well as for management of recurrent bladder cancer. The European Consensus publication “Witjes JA, et al. Clinical and Cost Effectiveness of Hexaminolevulinate-guided Blue-light Cystoscopy: Evidence Review and Updated Expert Recommendations. Eur Urol (2014)” can be viewed here.

For further information, please contact:
 
Photocure
President & CEO Kjetil Hestdal
Tel: + 47 913 19 535, Email: kh@photocure.no
CFO Erik Dahl
Tel: +47 450 55 000, Email: ed@photocure.no

Hume Brophy
Mary Clark, Hollie Vile, Supriya Mathur
Tel: +44 20 3440 5653, Email: photocure@humebrophy.com



[1] Consensus Conference on Blue Light Cystoscopy with Cysview sponsored by Photocure and KARL STORZ Endoscopy-America.