Cysview (hexaminolevulinate) / Photocure, Asieris - LARVOL DELTA

Predicting Recurrence and Progression in Contemporary Patients with NMIBC Undergoing Blue Light Cystoscopy-Aided Transurethral Resection of Bladder Tumor (AUA 2025) - " We identified unique patients aged 18-89 years in the multi-institutional Blue Light Cystoscopy with Cysview Registry who underwent BLC-aided TURBT between 2014-2023... Using a multi-institutional cohort, we developed predictive models for recurrence and progression in patients treated with BLC. Although they require external validation, these models reflect to contemporary treatment paradigms – including BLC and adjuvant therapies – and can inform personalized, risk-adapted management of NMIBC."

Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Performance of the EORTC and CUETO Risk Prediction Models in Contemporary Patients Undergoing Transurethral Resection of Bladder Tumor with Blue Light Cystoscopy (AUA 2025) - " We identified patients aged 18-89 years in the multi-institutional Blue Light Cystoscopy with Cysview Registry who underwent BLC-TURBT between 2014-2023... In a contemporary cohort of patients undergoing BLC-TURBT, the EORTC and CUETO models demonstrated poor performance in predicting RFS and PFS. The EORTC model generally under-estimated RFS and PFS, particularly for higher risk patients, while the CUETO model demonstrated inconsistent results. These results underscore the need for the development of more accurate predictive models to guide the risk-adapted management of NMIBC in patients undergoing BLC-TURBT."

Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Upstaging and risk migration with blue light cystoscopy for non—muscle-invasive bladder cancer: Results from a prospective multicenter registry (AUA 2025) - " Using data from the prospective multi-institutional Cysview Registry (2014-2024), patients with NMIBC who underwent transurethral resection or biopsy of bladder tumors were identified... Using BLC during transurethral resection or biopsy of bladder tumors results in risk group migration in over 9% of patients with NMIBC. This impacts patient management, including the administration of intravesical therapy when it was not initially planned, an extension in the duration of therapy, or the decision to proceed with radical cystectomy."

Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urology

Photocure ASA: Results for the fourth quarter of 2024 (PRNewswire) - "Photocure ASA...reported Hexvix/Cysview revenues of NOK 128.6 million in the fourth quarter of 2024 (Q4 2023: NOK 114.2 million) and EBITDA of NOK 8.5 million (NOK 29.9 million). Photocure expects product revenue growth in the range of 7% to 11% and year-over-year EBITDA improvement in 2025. While the company is not providing a specific EBITDA guidance range, Photocure expects continued operating leverage flow-through in its core commercial business and significant growth in milestones this year."

Sales • Bladder Cancer • Urothelial Cancer

Upstaging and risk migration with blue light cystoscopy for non–muscle-invasive bladder cancer: Results from a prospective multi-center registry. (ASCO-GU 2025) - " Using data from the prospective multi-institutional Cysview Registry (2014-2024), patients with NMIBC who underwent transurethral resection or biopsy of bladder tumors were identified... Using BLC during transurethral resection or biopsy of bladder tumors results in risk group migration in over 9% of patients with NMIBC. This impacts patient management, including the administration of intravesical therapy when it was not initially planned, an extension in the duration of therapy, or the decision to proceed with radical cystectomy. Clinical features of patients with malignant lesions detected by BLC only (A) and those with risk group migration (B).IQR: interquartile range; NA: not available."

Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: Johns Hopkins University | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

ALOPECIA AS AN UNCOMMON SIDE EFFECT OF SINGLE POSTOPERATIVE INSTILLATION OF GEMCITABINE IN PATIENTS WITH NON-MUSCLE INVASIVE UROTHELIAL CARCINOMA OF THE BLADDER: A MULTI-INSTITUTION EXPERIENCE (SUO 2024) - " Using the IRB-approved multi-institutional Cysview registry database, we identified patients who underwent TURBT for NMIBC and received a single dose of intravesical gemcitabine post-TURBT between January 2020 and June 2024 at the University of Southern California, Columbia, UCLA, Mount Sinai, Baylor, Johns Hopkins University and the University of Pennslyvania...None of the patients had previous intravesical gemcitabine; however, 2 patients had a history of intravesical BCG and 1 had intravesical mitomycin C before... This study demonstrates that hair loss is one of the uncommon adverse effects of intravesical gemcitabine after TURBT. Prior to surgery, patients should be informed about this adverse effect. Additional research and larger multicenter studies are required to describe the occurrence and cause of this adverse event."

Adverse events • Clinical • Alopecia • Bladder Cancer • Genito-urinary Cancer • Immunology • Oncology • Solid Tumor • Urothelial Cancer

Comparison of 3 Months Recurrence Free Survival by 3–10 mm Recurrent Non-Muscle Invasive Bladder Cancer Treated by Flex PDD Guided Laser Photo Coagulation in Local Anesthesia at Outpatient Clinic versus Trans Urethral Resection of Bladder Tumor in General Anesthesia (SIU 2024) - "Intravesical application of Hexvix and 20 mL of Xylocain 1% was done 1 h before the procedure patients treated by DLBC... Recurrence free survival of recurrent NMIBC 3–10 mm was 4% higher in patients treated with PDD guided diode laser photo coagulation in local anesthesia than in patients treated by PDD guided TURB in general anesthesia."

Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urethral Cancer

Alopecia as an uncommon side effect of single postoperative instillation of gemcitabine in patients with non-muscle-invasive urothelial carcinoma of the bladder. (ASCOQLTY 2024) - " Using our single-institutional IRB-approved Cysview registry database, we identified patients who underwent TURBT for NMIBC and received a single dose of intravesical gemcitabine post-TURBT between January 2020 and June 2023 at Keck Hospital of USC...None of the patients had previous intravesical gemcitabine; however, 2 patients had a history of intravesical BCG and 1 had intravesical mitomycin before... This study demonstrates that hair loss is a rare but possible adverse effect of intravesical gemcitabine after TURBT. Prior to surgery, patients should be counseled regarding this potential side-effect. Additional research and multicenter studies are required to describe the occurrence and cause of this adverse event.."

Adverse events • Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

CUT-less: Vesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to Avoid Secondary Resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs) (clinicaltrials.gov) - P4 | N=327 | Not yet recruiting | Sponsor: University of Roma La Sapienza | Trial primary completion date: Jul 2027 ➔ Dec 2027

Head-to-Head • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Photocure ASA: Results for the second quarter of 2024 (PRNewswire) - "Photocure ASA...today reported Hexvix/Cysview revenues of NOK 122.4 million in the second quarter of 2024 (Q2 2023: NOK 115.9 million) and EBITDA of NOK 27.8 million (NOK 23.4 million). Photocure reiterates its 2024 financial guidance of product revenue growth of 6% to 9% in constant currency and positive EBITDA excluding business development expenses."

Sales • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

TUR_BLUE: The Impact of PDD During TURB for NMIBC (clinicaltrials.gov) - P4 | N=300 | Not yet recruiting | Sponsor: A.O.U. Città della Salute e della Scienza

New P4 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Outcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection (clinicaltrials.gov) - P3 | N=200 | Not yet recruiting | Sponsor: Johns Hopkins University

New P3 trial • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Photocure and Richard Wolf Enter into Agreement to Develop a High-Definition Flexible Blue Light Cystoscope for Global Commercialization (PRNewswire) - "Photocure ASA...today announces that it has entered into a strategic agreement with Richard Wolf GmbH to develop and commercialize a next-generation 4K LED high-definition (HD) reusable flexible blue light cystoscope based on Richard Wolf's System blue technology. The partnership between Photocure and Richard Wolf is focused on developing technologically advanced flexible blue light cystoscopy (BLC) equipment for the global market so that physicians who treat patients with bladder cancer can offer the benefits of BLC with Hexvix / Cysview in an outpatient, or surveillance setting...Under the Agreement, Richard Wolf will develop the new flexible BLC system with input and guidance from Photocure, tapping into Photocure's extensive knowledge of the surveillance procedure and the Company's experience with urology customers."

Licensing / partnership • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Blue Light Cystoscopy versus White Light Cystoscopy for the Detection of Bladder Cancer using modern HD 4K equipment: An Analysis of Pivotal Trial and Real-World Data in China (AUA 2024) - P3 | "Patients received intravesical HAL (Hexvix, Photocure ASA) and underwent WLC before BLC (System blue, Richard Wolf GmbH)... Data from the first RCT and supporting RWS conducted in China re-confirm the superiority of HAL BLC over WLC, using state-of-the-art HD 4K equipment, in detecting bladder cancer, especially CIS. HAL and System blue also demonstrate good tolerability."

Clinical • Real-world • Real-world evidence • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Asieris Pharmaceuticals Unveils 2023 Annual Report, Core Product APL-1702 Succeeds in Global Phase III Clinical Trials, APL-1706 obtains NDA acceptance domestically, Specialty Commercial Team Generates Sustained Revenue Streams (PRNewswire) - "The company is gearing up to submit a market approval application for APL-1702 to China's National Medical Products Administration (NMPA), with acceptance anticipated in the second quarter of 2024....The company is progressing through the review process and anticipates an NMPA approval by June 2025."

Non-US regulatory • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Racial Differences in the Detection Rate of Bladder Cancer Using Blue Light Cystoscopy: Insights from a Multicenter Registry. (PubMed, Cancers (Basel)) - "Clinicopathologic information was collected from patients enrolled in the multi-institutional Cysview® registry (2014-2021) who underwent transurethral resection or biopsy of bladder tumors...Additionally, the positive predictive value of BLC was highest in Asian patients (94%), while Hispanic patients had the highest negative predictive value (86%). Our study showed that regardless of race, BLC increases the detection of bladder cancer when combined with WLC."

Journal • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

CUT-less: Vesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to Avoid Secondary Resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs) (clinicaltrials.gov) - P4 | N=258 | Not yet recruiting | Sponsor: University of Roma La Sapienza | Initiation date: Feb 2024 ➔ Jun 2024 | Trial primary completion date: Feb 2027 ➔ Jul 2027

Head-to-Head • Trial initiation date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Photocure ASA: Results for the fourth quarter of 2023 (PRNewswire) - "Photocure ASA...reported Hexvix/Cysview revenues of NOK 114.2 million in the fourth quarter of 2023, an increase of 20% over the prior-year period (Q4 2022: NOK 94.9 million), and EBITDA of NOK 29.9 million (NOK -16.9 million) following solid business development for the Company. Total revenues increased 37% in the fourth quarter of 2023 compared to Q4 2022, including a milestone payment from Asieris related to the license agreement for Cevira."

Sales • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Blue light cystoscopy versus white light cystoscopy for the detection of bladder cancer in China: An analysis of unpublished clinical trial and real-world data. (ASCO-GU 2024) - P3 | "Patients received intravesical HAL (Hexvix, Photocure ASA) and underwent WLC before BLC (System blue, Richard Wolf GmbH)... Both RCT and RWS confirm the superiority of BLC based on innovative LED technology with HAL over WLC in detection of bladder cancer in Chinese populations, especially CIS, and HAL is well tolerated. Clinical trial information: NCT05600322."

Clinical • Real-world • Real-world evidence • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Asieris Releases Phase III Clinical Study and Real-World Research Data for APL-1706, a Bladder Cancer Diagnosis and Management Drug, at the 2024 ASCO-GU (PRNewswire) - P3 | N=158 | NCT05600322 | Sponsor: Photocure | "Asieris Pharmaceuticals...announced the release of Phase III clinical trial data and real-world study data for APL-1706 (compound name: Hexaminolevulinate Hydrochloride for Intravesical Solution), a bladder cancer diagnosis and management drug , at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium...The study included 158 patients enrolled in a randomized controlled trial (RCT), with 37 patients in the training group and 6 patients randomly assigned to the non-Blue Light Cystoscopy (BLC) group, one patient withdrew...Among patients diagnosed with Ta, T1, or CIS, 42 out of 97 patients (43.3%) in the RCT and 4 out of 12 patients (33.3%) in the RWS had at least one lesion detected by BLC but not by white light cystoscopy (WLC) (p<0.0001). In the RCT, 11 out of 114 (9.6%) CIS patients, and in the RWS, 1 out of 14 (7.1%) CIS patients had additional CIS lesions detected under BLC that were not found by WLC."

P3 data • Bladder Cancer

SENTINEL-1: A FEASIBILITY STUDY OF FLUORESCENCE ENHANCED PELVIC LYMPH NODE DETECTION USING INTRAVESICAL HEXAMINOLEVULINATE HCL DYE FOR PATIENTS WITH MUSCLE-INVASIVE BLADDER CANCER (SUO 2023) - "Enrollment opened on December 1, 2022. "

Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Photocure Partner Asieris announces New Drug Application acceptance for regulatory review of Hexvix in China (PRNewswire) - "Photocure ASA...announces that its partner Asieris Pharmaceuticals...communicated today that the National Medical Products Administration (NMPA) accepted the new drug application (NDA) for Hexvix^® (APL-1706) in China....Results of the Hexvix (APL-1706) Phase III clinical trial in China were presented at the 43rd Congress of the Société Internationale d'Urologie (SIU) last month, as a late-breaking abstract."

Non-US regulatory • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Comparative Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer (clinicaltrials.gov) - P3 | N=158 | Completed | Sponsor: Photocure | Active, not recruiting ➔ Completed | N=380 ➔ 158

Enrollment change • Trial completion • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Photocure ASA: Results for the third quarter of 2023 (PRNewswire) - "Photocure ASA...reported Hexvix^®/Cysview^® revenues of NOK 107.3 million in the third quarter of 2023 (Q3 2022: NOK 96.9 million), and an EBITDA of NOK 3.3 million (NOK 4.7 million) for the company."

Sales • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer