Photocure ASA

Legal Proceedings Report • Sep 20, 2022

New study demonstrates that tumor removal in the outpatient setting is as good as TURBT under general anesthesia

New study demonstrates that tumor removal in the outpatient setting is as good as TURBT under general anesthesia

Press release - Oslo, Norway, September 20th, 2022: Photocure ASA, The Bladder

Cancer Company, announces the publication of first results from the Laser III

clinical study in the medical journal, European Urology. The study is part of a

systematic program aimed at verifying the safe treatment of bladder tumors in

the outpatient setting. Laser III results demonstrate the non-inferiority of

outpatient laser-mediated destruction of bladder tumors in conjunction with blue

light cystoscopy (BLC[®]) and Hexvix[®] versus inpatient BLC TURBT* under

general anesthesia. Photocure has supported this program and the specific study

since 2016.

Laser III is a prospective, randomized, non-inferiority trial conducted in the

Capital Region of Denmark from 2016 to 2020 (NCT02886026). Patients with

histologically verified Ta low-grade bladder tumor recurrence were enrolled. A

total of 206 patients were randomized; 176 finished treatment and were available

for follow-up as per protocol. The first results, now published in European

Urology, evaluated 4-month non-inferiority of outpatient laser-mediated ablation

of recurrent Ta tumors with flexible cystoscopes under local anesthesia,

compared to TURBT under general anesthesia. Both the out-patient laser procedure

and TURBT procedure were performed under BLC-guidance. Four-month recurrence

-free survival was assessed as the primary endpoint with a predefined non

-inferiority criterion of 15%. Secondary outcome measures were pain during the

outpatient laser ablation, postoperative morbidity, postoperative complications,

and patient's preference. The 12-month follow-up results are expected to be

presented in a second paper.

Four-month recurrence-free survival was 8% higher after laser-ablation of the

bladder tumor compared to TURBT, and the predefined noninferiority criterion was

met. The study authors conclude that laser intervention in the outpatient

setting is as good as TURBT with general anesthesia, and has less complications.

In addition, the paper also advocates the importance of enhanced cystoscopy to

mediate this practice change. As recommended by the guidelines, enhanced

cystoscopy should be used during surgical treatment of non-muscle invasive

bladder cancer to improve detection and reduce recurrence.

"The study outcomes clearly demonstrate that for patients with small low grade

stage Ta bladder tumors the procedure can be safely moved from the OR to the

office, thereby reducing the burden for patients stemming from general

anesthesia and cost related to hospital stays. Safety is the most important term

here. Our team find that blue light cystoscopy with Hexvix in the OPD support

the identification of small bladder tumors which therefore safely can be removed

with laser before they become too large for outpatient treatment." said Dr.

Gregers G Hermann, the Lead Investigator of this study and Consultant Urologist,

MD, DM Sc, F.E.B.U., Dept. of Urology, Herlev/Gentofte hospital, Denmark.

"We expect to see more scientific studies investigating how some of the more

intensive procedures like TURBTs can be reduced, avoided, or made more bearable

for patients. In non-muscle-invasive bladder cancer especially, where most

patients are over 55 years old, research into reducing patient burden is of

great importance. We believe BLC with Hexvix/Cysview can help responsible

researchers in these efforts by minimizing the concern of uncertainty when it

comes to detecting the tumors," said Dan Schneider, President and CEO of

Photocure.

Read the full publication here:

https://www.sciencedirect.com/science/article/abs/pii/S0302283822025647

(Clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT02886026)

*TURBT: Transurethral resection of bladder tumor

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