Photocure: Nordic registry clinical data and multiple scientific programs at AUA 2023 Congress reinforce the benefits of Blue Light Cystoscopy

OSLO, Norway, May 2, 2023 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that results from the Nordic Registry demonstrating benefits of Blue Light Cystoscopy (BLC^®) were presented at the AUA 2023 Conference: the American Urological Association Annual Congress 2023 which was held April 28 - May 1, 2023 in Chicago, IL, USA. The study highlighted that BLC in surveillance of NMIBC* improves the detection of malignant lesions, enhances physicians' confidence, and may reduce patients' tumor burden through immediate fulguration. In addition, Photocure sponsored an educational CME session entitled "How The Experts Treat NMIBC During a BCG Shortage - Integrating Recent Approvals and Investigational Therapies."

On Friday, April 28^th, 2023, Consultant Urologist Karsten Zieger, MD, PhD, Lillebælt Hospital, Department of Urology, Vejle, Denmark, presented results from a Real-World Evidence study during a moderated poster session. This Nordic Registry study, which is supported by Photocure, included data from 319 patients and 436 Blue Light Flexible Cystoscopies performed in the surveillance of NMIBC. The study results showed that flexible blue light cystoscopy with Hexvix^®/Cysview^®, as an adjunct to white light cystoscopy for surveillance of NMIBC, improves the detection of malignant lesions. In the study, biopsies were taken from 452 lesions, showing malignancy in 126/409 (31%) lesions positive for blue light. In 86 of the cystoscopies (20%), lesions were identified only by blue light. Furthermore, it improves surgeons' confidence in identifying clinically important lesions with physicians reporting benefit of BLC in 367/436 (84%) of the cystoscopies. The combination of BLC with immediate fulguration of tumors in an outpatient setting may positively affect the patients' burden in NMIBC. The impact on patients' overall outcome is the target of future evaluations.

Read the abstract here: https://www.auajournals.org/doi/10.1097/JU.0000000000003223.15

The Photocure-sponsored CME event "How the Experts Treat NMIBC During a BCG Shortage – Integrating Recent Approvals and Investigational Therapies" on April 28^th, 2023 covered insights on novel treatment strategies and diagnostics, including a segment on Blue Light Cystoscopy with Hexvix/Cysview. During this satellite symposium, Dr. Joshua Meeks MD, PhD Associate Professor of Urology and Biochemistry and Molecular Genetics, Northwestern University (Chicago IL) presented information on the use of BLC technology as a useful tool to find patients for these new interventional treatments, especially in a post-BCG setting.

The CME program attracted 150+ attendees joining in person or via live webinar. A webcast is available at: bit.ly/AUA_NMIBC-archive

"We analyze and track the presence of BLC scientific discussions and clinical presentations at major urology conferences. Both at EAU and AUA, presentations highlighted the value BLC provides in detection and in supporting a complete resection; while other sessions explained clinical benefits of BLC in a real-world settings, related to TURBTs and surveillance.", said Anders Neijber, Chief Medical Officer, Global Medical Affairs and Clinical Development and R&D at Photocure "Additionally the EAU guidelines have been updated in 2023 to reflect current data, systematic reviews and meta-analyses of randomized controlled trials (RCTs) like the 2021 Cochrane Review. Overall, we observe an increased interest and attention in BLC at domestic and international medical conferences and within peer-reviewed publications, underscoring the value of BLC in bladder cancer care."

In addition to the scientific program, BLC received a lot of attention at the Photocure and Karl Storz booths. The continued collaboration on commercializing Karl Storz's high-definition rigid BLC system Saphira™ at AUA allowed uro-oncologists to get hands-on experience with the new blue light device. Geoff Coy, Vice President & General Manager North America at Photocure commented: "Visitors were highly engaged in discussions about the role of BLC with Cysview in their practice. Since launch in late 2022, new orders for Saphira and total tower placements continue to be strong, reflecting the commitment among hospitals and medical centers to incorporate the upgraded rigid BLC system into practice. Physicians have told us that the new system provides reliable performance and better image quality which, in turn, allows them to do more for their patients in the first and follow-up TURBT**. We are pleased with the high engagement of the medical and scientific community at AUA and are excited about the change that we can make collectively to improve the lives of patients with bladder cancer."

About the Nordic Registry

The Nordic Registry is a prospective, observational multicenter study which includes patients undergoing flexible Blue Light Cystoscopy for suspicion or surveillance of NMIBC in an outpatient setting. The registry collects data on patient demographics, bladder cancer history, findings under blue light and white light, patient preference, discomfort and treatment.

The American Urological Association (AUA) meeting is one of largest international meetings in the urology calendar. The yearly event includes an innovative, evidence-based, quality program for urologists and urologic health care professionals worldwide. Therefore, Photocure was pleased to sponsor this AUA CME program within NMIBC with an unrestricted educational grant to meet the scientific needs of a broad healthcare audience. Photocure remains committed to supporting the educational needs of uro-oncologists and the broader urology community.

*NMIBC: Non-muscle invasive bladder cancer

**TURBT: Transurethral resection of bladder tumor

Note to editors:

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA.

About Bladder Cancer

Bladder cancer ranks as the 8^th most common cancer worldwide – the 5^th most common in men – with 1 720 000 prevalent cases (5-year prevalence rate)^1a, 573 000 new cases and more than 200 000 deaths in 2020.^1b

Approx. 75% of all bladder cancer cases occur in men.¹ It has a high recurrence rate with up to 61% in year one and up to 78% over five years.² Bladder cancer has the highest lifetime treatment costs per patient of all cancers.³

Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike. 

Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.⁴

1 Globocan. a) 5-year prevalence / b) incidence/mortality by population.  Available at: https://gco.iarc.fr/today, accessed [January 2022].
2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3 Sievert KD et al. World J Urol 2009;27:295–300
4 Bladder Cancer. American Cancer Society. https://www.cancer.org/cancer/bladder-cancer.html

About Hexvix^®/Cysview^® (hexaminolevulinate HCl)

Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder, making them glow bright pink during Blue Light Cystoscopy (BLC^®). BLC with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves the detection of tumors and leads to more complete resection, fewer residual tumors, and better management decisions.

Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Chile, Australia, New Zealand and Israel. Please refer to https://photocure.com/partners/our-partners for further information on our commercial partners.

About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative solutions to improve the lives of bladder cancer patients. Our unique technology, making cancer cells glow bright pink, has led to better health outcomes for patients worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit us at www.photocure.com, www.hexvix.com, www.cysview.com

For further information, please contact:

Dan Schneider
President and CEO
Photocure ASA
Email: ds@photocure.com

Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: ed@photocure.com

David Moskowitz
Vice President, Investor Relations
Photocure ASA
Tel: +1 202 280 0888
Email: david.moskowitz@photocure.com

Media and IR enquiries:

Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: geir.bjorlo@corpcom.no

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