Company Announcements

OSLO, Norway , March 16, 2026 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces two "trial in progress" presentations at the 2026 European Association of Urology congress (EAU) in London, UK. These trials investigate different stages of the diagnostic pathway, addressing data gaps to improve individual patient care and outcomes.

The EAU annual meeting is one of the largest international meetings in the global urology calendar, showcasing the latest and most relevant clinical and scientific advancements in this area of patient care.

Photocure participated with its Hexvix^® product, designed for better detection and resection of bladder tumors. As in past sessions and as a service to non-attending urologists, Photocure will make 2026 EAU bladder cancer session highlights available to healthcare professionals after the event, by means of video interviews with the presenters of these sessions at the Photocure booth. This successful initiative is once again 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 educational activity, the EAU scientific program prominently featured Photocure's Hexvix product and/or the blue light cystoscopy procedure in which it is used. In particular, two notable bladder cancer "trial in progress" presentations from Monday, March 16, 2026 were:

A0648: VI-RADS & PDD-TURBT to avoid Second-look and Resection (Re-TURBT) in Non-Muscle Invasive Bladder Cancers: The CUT-less Randomized Clinical Trial

F. Del Giudice, Rome (IT)

The CUT-less trial investigates whether second-look TURB can be safely omitted by combining   preoperative staging accuracy of Magnetic Resonance Imaging (MRI) using the Vesical Imaging-Reporting and Data System (VI-RADS) with enhanced cystoscopy using blue-light-TURB

The primary endpoint of this randomized, single-center, non-inferiority trial is short-term bladder cancer recurrence. Patients eligible for second-look resection who are randomized to BL-TURB and demonstrate a very-low to low likelihood of muscle-invasive disease on MRI will omit the second-look resection, whereas patients randomized to WL-TURB will undergo the standard second-look resection. Over 3 years, 327 patients with intermediate- or high-risk NMIBCs* who are candidates for second-look TURBT will be enrolled. Results will also include building a health economic lifetime model, looking at cost-utility per quality-adjusted life year gained using 2-year clinical outcomes.

The CUT-less trial aims to generate evidence supporting a paradigm shift towards a more personalized, socially, and economically sustainable updated NMIBC therapeutic pathway across the European Union and potentially worldwide.

ClinicalTrial.gov identifier (ID): NCT05962541 Read more: https://urosource.uroweb.org/resource-centres/EAU26/268344/abstract
 

A0649: Trial in progress: Evaluation of urinary minimal residual disease and outcomes in high-risk non-muscle invasive bladder cancer surveilled with blue light compared to white light cystoscopy

A.K. Smith, Bethesda (US)

Urinary comprehensive genomic profiling offers a non-invasive method to assess the presence or extent of bladder cancer. The urinary biomarker UroAmp (Convergent Genomics) detects minimal residual disease (MRD). By enhancing tumor margin visualization, Blue Light Cystoscopy (BLC) may improve TURBT (transurethral resection of bladder tumors) completeness. This randomized controlled trial (RCT) enrolls high-risk NMIBC patients receiving either standard of care white light or Blue Light Cystoscopy. UroAmp will be used to evaluate completeness of resection for each modality.

The study will enroll 200 subjects undergoing TURBT for suspected high risk NMIBC randomized 1:1 to WLC or BLC-enhanced cohorts. Urinary MRD analyses will be conducted at all major decision points during treatment. The primary endpoint is the post-TURBT difference in MRD scores between the BLC and WLC arms. Secondary clinical outcomes include recurrence-free survival at 12 and 24 months.

Clinical Trial Registry number is NCT06525571. Read more: https://urosource.uroweb.org/resource-centres/EAU26/268251/abstract

"Photocure's support for these trials underscores our commitment to the transformation toward more personalized, data-driven care in uro-oncology, enabling better clinical outcomes and supporting the shift toward precision medicine. Minimally invasive procedures are on the rise and these trials address data gaps in the care pathway and in the impact of complete TURBTs using BLC to reduce tumor burden on clinical outcomes for high-risk patients. At Photocure, we strongly believe that the clinical utility of different precision diagnostic techniques can be optimized by using them in combination and in sequence throughout the patient pathway to inform physician decision-making and provide value for patients and healthcare. The same is true for their use in clinical trials," said Anders Neijber, Chief Medical Officer of Photocure.

During the EAU Congress on March 13, 2026, Photocure, in collaboration with medac, hosted a well-attended scientific event titled "Optimising Care in Bladder Cancer." The session was moderated by Mr. John McGrath (Consultant Urological Surgeon North Bristol Trust). The program brought together leading clinicians to discuss current challenges and advances in bladder cancer management, with a focus on improving patient pathways, in particular outcomes for women. This collaboration between Photocure and medac reflects a shared commitment to advancing evidence-based practice and supporting healthcare professionals in delivering high-quality, patient-centered bladder cancer care.

*NMIBC: Non-muscle invasive bladder cancer
**TURBT: trans-urethral resection of bladder tumors

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About Bladder Cancer
Bladder cancer ranks as the 8^th most common cancer worldwide – the 5^th 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.

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

CONTACT:

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

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