Photocure Completes Enrollment in US Market expansion study of Blue Light Flexible Cystoscopy (BLFC) with Cysview ®

Oslo, Norway, February 3, 2017 Photocure ASA (OSE: PHO), announced today that it has completed enrollment in its Phase 3 study with BLFC with Cysview in patients with Non Muscle Invasive Bladder cancer (NMIBC) undergoing follow up (surveillance) cystoscopy in the outpatient setting. The enrollment of 300 bladder cancer patients has secured that a minimum of 100 patients have been referred to and received repeat administrations of Blue Light Cystoscopy with Cysview in the operating room setting. In the study, Cysview was used in conjunction with the flexible KARL STORZ system. Results from the study are expected to be available mid-2017.

“This is an important milestone for Photocure as we plan to use the data from this study to seek FDA approval for the expanded use of BLFC with Cysview into the surveillance market in the United States, where it is estimated that 1.4 million surveillance cystoscopies are performed annually. We believe that availability of BLFC in this setting will allow patients access to optimal surveillance of their disease resulting in earlier treatment, which should result in improved long-term benefits and outcomes for these patients”, said Kjetil Hestdal, President & CEO.
The prospective, multicenter Phase 3 study will define the possible improved detection rates and impact on patient management of bladder cancer in the surveillance setting with BLFC with Cysview as an adjunct to white light cystoscopy. Seventeen leading institutions participated in the study.

For more information about the study: https://clinicaltrials.gov/ct2/show/NCT02560584

About Photocure ASA
Photocure, headquartered in Oslo Norway, is a specialty pharmaceutical company and world leader in photodynamic technology. The company is listed on the Oslo Stock Exchange.
Information about Photocure is available at www.photocure.com.

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Company contacts
Kjetil Hestdal, President and CEO
Tel: +47 913 19 535
Email: kh@photcure.no

Erik Dahl, Chief Financial Officer
Tel: +47 450 55 000
Email: ed@photocure.no 

References
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[2] Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2016.
[3] Hall M, Chang S, Dalbagni G et al. Guideline for the Management of Nonmuscle Invasive Bladder Cancer (Stages Ta, T1, and Tis): 2007 Update. J Urol. 2007;178(6):2314-2330.
[4] Avritscher EB et al., Clinical model of lifetime cost of treating bladder cancer and associated complications. Urology. 2006; 68:549-553.
[5] Botteman et al. Clinical model of lifetime costs of treating bladder cancer: a comprehensive review of the published literature. Pharmacoeconomics. 2003; 21:315-1330.
[6] Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2016.
[7] Bladder Cancer. American Cancer Society. http://www.cancer.org/acs/groups/cid/documents/webcontent/003085-pdf.pdf. Accessed April 2016