Photocure: New data presented at EAU 2023 highlight the effects of blue light cystoscopy in bladder cancer

14 Mar 2023 08:00 CET

Oslo, Norway, March 14, 2023: Photocure ASA (OSE: PHO), the Bladder Cancer
Company, announces its participation in the congress, and two abstract
presentations at the European Association of Urology congress (EAU) in Milan,
Italy, highlighting the benefits of Blue Light Cystoscopy (BLC[®]) in Bladder
Cancer management.

The EAU annual meeting is one of the largest international meetings in the
urology calendar, showcasing the latest and most relevant knowledge in this area
of patient care. This year's event was held on March 10 -13, 2023 and attracted
urologists from all over the world. In addition to an active presence & support
for the event, Photocure will also be making bladder cancer session highlights
available post event by means of video interviews with the presenters of these
sessions. This initiative is supported by two of the leading names in Bladder
Cancer in Europe, Prof. M. Rouprêt, APHP, Sorbonne University Paris, France and
Prof. P. Gontero, Division of Urology, University of Studies of Torino, Italy.

In addition to this activity, two abstract presentations were presented as part
of the EAU scientific program that feature the blue light cystoscopy procedure:

Immunological changes following blue light cystoscopy with hexaminolevulinate in
bladder cancer (A0431 - Sunday 10:45)
The project conducted at Department of Molecular Medicine, Aarhus University
Hospital, Denmark, presents results from a pilot study of bladder cancer
patients, showing that blue light cystoscopy with Hexaminolevulinate (HAL)
during TURBT* may influence the immune cell composition and tumor
microenvironment. Preliminary findings suggest that BLC-guided TURBT changes the
expression of immune cells of both the adaptive and innate immune system
compared to WLC-guided TURBT. Further studies are required to validate the
clinical impact of these observations.

Read the abstract: https://resource-centre.uroweb.org/resource
-centre/EAU23/248125/Abstract

Blue Light Cystoscopy Delays Time to Recurrence in Non-Muscle Invasive Bladder
Cancer Patients Treated in a Real-World Setting (A0710 - Sunday 15:45)
Real-world data taken from the Blue Light Cystoscopy with Cysview[®] Registry
(Clinicaltrials.gov; NCT02660645), the largest non-muscle-invasive bladder
cancer registry in the U.S., showed that use of BLC significantly decreased the
risk of recurrence and prolonged time to recurrence compared to White Light
alone (HR 0.33; 95% 95% CI 0.2-0.40, p<0.0001). Additionally, BLC in patients
with primary tumors extended time to recurrence compared to recurrent patients
(HR 1.12; 95% CI 0.89-1.41, p<0.001), suggesting that the earlier use of BLC
might have more favorable long-term outcomes in a real-world setting.

Read the abstract: https://resource-centre.uroweb.org/resource
-centre/EAU23/245863/Abstract

"These new study results continue to emphasize the importance of performing a
thorough TURBT using Blue Light Cystoscopy in the treatment of bladder cancer,
and also demonstrate the strong interest from the scientific community to
investigate Hexvix[®]/Cysview's potential immunologic effects in bladder cancer
management. BLC has been shown to clinically increase TURBT quality, more
accurately stage disease for treatment, and enable better recurrence monitoring,
supporting the long-term utility to help improve the lives of patients with
bladder cancer," said Dan Schneider, President and CEO of Photocure.

"As we continue to broaden the awareness of BLC with Hexvix throughout Europe,
it is a privilege to participate in the EAU congress, and to see so much
engagement from the scientific community and urologists alike. The expanding
number of scientific sessions featuring Blue Light is impressive this year. It
empowers us on our journey to bring this important product and procedure to even
more new users in Europe" added Susanne Strauss, Vice President and General
Manager Europe.

*TURBT: trans-urethral resection of bladder tumors

Note to editors

Hexvix[®]/Cysview[®] and BLC[®] are registered trademarks of Photocure ASA.

This press release may contain product details and information which are not
valid, or a product that is not accessible, in your country. Please be aware
that Photocure does not take any responsibility for accessing such information,
which may not comply with any legal process, regulation, registration, or usage
in the country of your origin.

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 annually 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 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

More information:
Access the news on Oslo Bors NewsWeb site

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