New publication of Hexvix trial data from China: blue light cystoscopy with Hexvix significantly improves the detection of bladder cancer using modern HD equipment

12 Jan 2026 17:42 CET

Press release – Oslo, Norway, January 12th, 2026: Photocure announces the
publication of the study “Hexaminolevulinate blue light cystoscopy improves
bladder cancer detection in comparison to white light cystoscopy: a prospective,
comparative, within-patient controlled multicenter phase III bridging study in
China” in the Frontiers of Urology journal this week.

An abstract with data from this pivotal prospective randomized controlled
multi-center Phase 3 trial was first presented at the Congress of the Société
Internationale d’Urologie (SIU) in October 2023. Its main objective was to
compare and show a significant improvement between Hexvix/Cysview®
(hexaminolevulinate) blue light cystoscopy (BLC®) and white light cystoscopy
(WLC) in the detection rate of bladder cancer, using Richard Wolf’s modern
state-of-the-art “System blue” high-definition cystoscopy equipment.

Of the 158 enrolled patients, 97 patients had non-muscle-invasive bladder
cancer. Patients received intravesical Hexvix/Cysview and underwent WLC and
high-definition BLC. The primary efficacy endpoint was the proportion of
patients with histology-confirmed tumors (Ta, T1, or CIS) who had at least one
such tumor detected during BLC, but not during WLC. Secondary endpoints included
detection of CIS, lesion detection rates, false positive rate, and safety.

Key findings: Compared with WLC, the proportion of patients with additional
bladder cancer lesions detected by BLC was 43.3% (p＜0.0001). The proportion of
patients with CIS lesions detected by BLC and not by WLC was 9.6%. Detection
rates for CIS, Ta, T1 and T2-T4 tumors were 94.7%, 100%, 98.2% and 100% for BLC
and 42.1%, 76.1%, 91.2% and 100% for WLC, respectively.

The study authors conclude that in the setting of modern high-definition
equipment, blue light cystoscopy with Hexvix/Cysview significantly improves the
detection of bladder cancer and with favorable safety.

“The detection rates for CIS from this trial in a contemporary clinical setting
using modern HD equipment are convincing, and in line with prior regulatory
trials with BLC. The use of full HD cystoscopy equipment even seems to widen the
tumor detection gap comparing white light and blue light cystoscopy with
Hexvix/Cysview. The difference in detection rates for CIS between BLC and WLC is
52.6% (18 out of 19 lesions, 94.7%, for BLC and 8 out of 19 lesions, 42.1%, for
WLC). In 2025, we saw the evolution towards blue light cystoscopy use as best
practice being recognized in the updates to several national urology guidelines.
The role of enhanced cystoscopy for accurate staging and identifying CIS is
increasing with the new emerging novel therapies in NMIBC,” said Anders Neijber,
Chief Medical Officer at Photocure.


Read the full publication here:
https://www.frontiersin.org/articles/10.3389/fruro.2025.1713128

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About Bladder Cancer
Bladder cancer ranks as the 8th most common cancer worldwide – the 5th most
common in men – with 1 949 000 prevalent cases (5-year prevalence rate)1a, 614
000 new cases and more than 220 000 deaths in 2022.1b
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 [February 2024].
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.
The following safety information is solely included to comply with U.S.
regulatory requirements: Important Risk & Safety Information for Cysview®
(hexaminolevulinate HCl)

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/news.

For more information, please contact:

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

Erik Dahl
CFO
Photocure ASA
Tel: +47 45055000
Email: ed@photocure.com

Priyam Shah
Vice President Investor Relations
Tel : +17176815072
Email: priyam.shah@photocure.com

Media enquiries:

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

More information:
Access the news on Oslo Bors NewsWeb site

663490_New publication of Hexvix tria.pdf