AUA Abstracts Further Support Role for Cysview® in the Office Setting

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OSLO, Norway, May 16, 2020 /PRNewswire/ -- Photocure ASA (OSE: PHO) today announced key data was published by the 2020 American Urological Association (AUA) Annual Virtual Meeting. Three abstracts featured Blue Light Cystoscopy (BLC™) with Cysview, and on June 27, 2020 BLC with Cysview will be included in a virtual session of the AUA program: "Surgical Techniques: Tips & Tricks Oncology: Bladder Cancer Blue Light" with Dr. Anne Schuckman.

MP 73-11: Role of blue light cystoscopy in detecting invasive bladder tumor: Data from a multi-institutional registry https://www.auajournals.org/doi/10.1097/JU.0000000000000959.011

MP 24-06: Gender based Variations in the Detection of Bladder Cancer with Blue Light Cystoscopy: Insights from a Multicenter Registry https://www.auajournals.org/doi/10.1097/JU.0000000000000857.06

MP 73-02: Malignant urinary cytology of unknown origin-blue light flexible cystoscopy at the outpatient clinic may be a valuable diagnostic tool https://www.auajournals.org/doi/10.1097/JU.0000000000000959.02

The Role of blue light cystoscopy in detecting invasive bladder tumor: Data from a multi-institutional registry showed that in the registry enrolled patients, a considerable proportion of invasive bladder tumors were detected by BLC alone: A total of 55 invasive lesions, of the 494 invasive lesions detected, were detected only by blue light cystoscopy. The benefit of using BLC in earlier detection of invasive bladder tumors could have an effect on the treatment approach and potentially lead to improved survival in the high-risk population. The study included 3514 lesions (1257 unique patients), from 9 sites in the U.S.

"Out of the overall 494 invasive lesions detected, 11% of them were only detected by BLC alone. Also, of 47 patients with BLC-only positive invasive lesions, 60% had concurrent CIS and 49% had an additional T1 lesion. Knowing when these high-risk tumors are present, especially concurrently, is critical to the optimal management of a patient's disease. We need this information in order to make the best treatment decisions, which can have a significant impact on the prognosis and quality of life, for our patients." says Siamak Daneshmand, MD, Director of Urologic Oncology Associate Professor of Urology, USC Institute of Urology.

Gender based Variations in the Detection of Bladder Cancer with Blue Light Cystoscopy: Insights from a Multicenter Registry showed that similar to existing evidence, BLC-alone was significantly more sensitive than WLC-alone in males (91.1% vs 80.0%, p<0.001) and in females (86.7% vs 79.5%, p = 0.036). Furthermore, the sensitivity with BLC between the genders was significantly greater in males than in females (91.1% vs 86.7%, p = 0.035). Additionally, the false-positive rate in females was significantly higher than in males in BLC (35.9% vs 28.5%, p=0.008) and WLC (33.8% vs 27.4%, p=0.029).  These findings highlight the differences in detection rates of NMIBC between genders, an area that warrants further investigation, and they continue to validate the existing evidence of increased sensitivity of BLC with Cysview in the detection of NMIBC.

Malignant urinary cytology of unknown origin - blue light flexible cystoscopy at the outpatient clinic, a Nordic prospective multicenter registry study, showed that the majority of patients, 93% (27/29), stated that they preferred to have BLC with Cysview performed with a flexible cystoscope at the outpatient clinic versus the operating room under general anesthesia.  It was concluded that using BLC with Cysview with a flexible cystoscope at the office may be a simple way to solve unclear cases with malignant or suspicious urinary cytology.

"At a time when patients and physicians are seeking to ensure bladder cancer detection and surveillance are being maintained in appropriate intervals, it is encouraging to see more data supporting the use of BLC with Hexvix/Cysview in the office setting." says Dan Schneider, President and CEO of Photocure. "Additionally, Cysview for use in high-risk patients helps both physicians and patients make difficult decisions that can impact patients' outcomes and quality of life.  As The Bladder Cancer Company we are proud to see that more data is being collected, and that it continues to add to the already existing evidence that the use of Hexvix/Cysview can play a critical role in disease management."

About Bladder Cancer
Bladder cancer ranks as the sixth most common cancer worldwide with 1 650 000 prevalent cases (5-year prevalence rate), 550 000 new cases and almost 200 000 deaths annually in 2018.¹

Approx. 75% of all bladder cancer cases occur in men.¹ It has a high recurrence rate with an average of 61% in year one and 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.<sup>4

1</sup> Globocan. Incidence/mortality by population. Available at: http://globocan.iarc.fr/Pages/bar_pop_sel.aspx 
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 is selectively taken up by tumor cells in the bladder making them glow bright pink during Blue Light Cystoscopy (BLCTM). BLC™ with Hexvix^® /Cysview^® improves the detection of tumors and leads to more complete resection, fewer residual tumors and better management decisions.

Cysview^® is the tradename in the US and Canada, Hexvix^® is the tradename in all other markets. Photocure is commercializing Cysview^® /Hexvix^® directly in the US and the Nordic region and has strategic partnerships for the commercialization of Hexvix^®/Cysview^® in Europe, Canada, Australia and New Zealand. Please refer to https://bit.ly/2wzqSQQ for further information on our commercial partners.

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

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CONTACT:

For more information, please contact:

Dan Schneider
President and CEO
Photocure ASA
Tel: + 1-609 759-6515
Email: ds@photocure.com

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

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