Hexaminolevulinate Hydrochloride

OSLO, Norway, May 7, 2024 /PRNewswire/ -- Photocure ASA (OSE: PHO) , the Bladder Cancer Company, announces its participation in the congress, and two abstract presentations at the AUA 2024: the American Urological Association Annual Congress 2024 was held May 3-6, 2024, in San Antonio, TX, USA. The results of the BRAVO study performed within the VA healthcare system showed significant decreases in the risk of recurrence and progression, as well as the potential for improved overall survival in patients who received a blue light cystoscopy (BLC®) compared to patients whose cystoscopy was only performed under white light. Another comparison of BLC with Hexvix®/Cysview® and white light cystoscopy (WLC), for the detection of bladder cancer using modern HD 4K equipment, was presented in an abstract from the multicenter phase III study of Hexvix in China, including new real world evidence data. On Sunday, May 5th, Dr. Sanjay Das presented the study, "Use of Blue Light Cystoscopy Among Non-Muscle Invasive Bladder Cancer Patients and Outcomes in an Equal Access setting: A Propensity Scored Matched Analysis." The study, known as BRAVO ( Bladder Cancer Recurrence Analysis in Veterans and Outcomes), is a retrospective, propensity score matched analysis that evaluated oncologic outcomes following BLC compared to WLC alone in patients from the Veterans Affairs Healthcare System. The study addresses a lack of practical real-world data comparing the impact of BLC versus WLC, specifically for recurrence, progression, and survival. The results of this study confirm that BLC use is associated with positive and statistically significant impacts on these outcomes. The Veterans' Affairs (VA) Healthcare system accepts all U.S. Veterans, regardless of financial background, and retains its patients, allowing for high-quality data capture over a long-term follow-up period, therefore serving as a robust real-world model for equal access. 626 patients were included in this study, 313 in each study arm (WLC versus BLC). Recurrence and progression data for BRAVO was measured at a 3-year time point. Overall survival follow-up was for 10 years. Study results include: Risk of recurrence was significantly lower following BLC (HR 0.60, 95% CI 0.29-0.61) – 40% reduction in risk of recurrence. This confirms data from multiple RCT studies. Patients who underwent BLC had significantly reduced risk of progression (HR 0.51, 95% CI 0.36-0.99) compared to patients who underwent WLC. There was improved overall survival among BLC vs. WLC (HR 0.41, 95% CI 0.30-0.72) Additionally, in the equal-access setting of the VA Healthcare System, benefits of BLC were equitably shared between race/gender. The Principal Investigator of the BRAVO Study, Dr. Steven Williams, commented: "The results of the BRAVO study performed within the VA healthcare system showed significant decreases in the risk of recurrence and progression, as well as the potential for improved overall survival in patients who received a BLC compared to patients who received WLC only. These findings demonstrate the benefit of BL-enhanced cystoscopy as part of comprehensive care for NMIBC* patients, especially as improved tumor visualization helps to appropriately make determination of intravesical therapy use, such as BCG. The results are encouraging and consistent with prior clinical trial long-term oncological outcomes. It supports the generalizability of prior clinical trial results in the real-world clinical practice setting. The demonstrated impact on overall survival warrants future studies to better understand the oncologic benefit of BLC in NMIBC." Read the abstract: On Monday, May 6th, a Poster presentation by Dr. Hailong Hu: 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 This pooled meta-analysis presented data from a randomized clinical trial and a supporting real-world evidence study conducted in China. Both studies enrolled patients with known or suspected bladder cancer. A total of 177 patients were enrolled, 128 patients underwent blue light cystoscopy (BLC) with Cysview (HAL) and were included in the full analysis set. Among patients diagnosed with Ta, T1, or CIS, 46 out of 109 patients (42.2%) had at least one lesion detected by BLC but not by white light cystoscopy (WLC) (p<0.0001). Fifteen patients had CIS of which 12 (80%) showed at least one additional CIS lesions found by BLC but not by WLC. The BLC detection rates for CIS, Ta, T1, and T2-T4 tumors were 95.2%, 100%, 98.3%, and 100%, respectively, while the WLC detection rates were 42.9%, 76.5%, 91.7%, and 100%, respectively. This study confirms the superiority of HAL BLC over WLC in the detection of bladder cancer even if improved WLC using HD 4K equipment is utilized. In particular, additional high-risk difficult to see CIS lesions have been identified in 80% of CIS patients only by HAL BLC. The quality of resection is still a key cornerstone in the treatment of NMIBC of which BLC remains a crucial part despite the further development of WLC imaging. Read the abstract: Beyond this groundbreaking data on BLC/WLC comparison, Photocure provided attendees with hands-on experience in the blue light cystoscopy with Cysview procedure on its congress booth, that featured a Saphira HD equipment tower. *NMIBC: Non muscle-invasive bladder cancer Note to editors: All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA. This press release may contain product details and information which are not valid, or a product 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 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: , 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. 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 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 , , For further information, please contact: Dan Schneider President and CEO Photocure ASA Email: [email protected] Erik Dahl CFO Photocure ASA Tel: +4745055000 Email: [email protected] David Moskowitz Vice President, Investor Relations Photocure ASA Tel: +1 202 280 0888 Email: [email protected] Media and IR enquiries: Geir Bjørlo Corporate Communications (Norway) Tel: +47 91540000 Email: [email protected] This information was brought to you by Cision The following files are available for download: SOURCE Photocure

OSLO, Norway, April 8, 2024 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces its participation in the congress, and two abstract presentations at the 2024 European Association of Urology congress (EAU) in Paris, France, 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 clinical and scientific advancements in this area of patient care. This year's event was held on April 5-8, 2024, and attracted urologists from all over the world. Similar to last year, Photocure will make 2024 EAU bladder cancer session highlights available to healthcare professionals post event, by means of video interviews with the presenters of these sessions on the Photocure booth D26. This highly engaging and 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 features Photocure's Hexvix® product and/or the blue light cystoscopy procedure in which it is used. In particular, two notable abstract presentations were: Outpatient laser coagulation of low-grade intermediate risk bladder tumor compared with TUR-BT, 12 months and long-term follow-up of a non-inferiority RCT (Abstract session 36 NMIBC: Benefits and harms of various treatment options, Sunday, 7 April, 17:15-18:45) Treatment of recurrent low grade intermediate risk bladder tumor is burdensome for patients and health care system. The primary objective of this study was to evaluate 12 months recurrence-free survival after out-patient department photo coagulation of bladder tumors (PC-BT) is non-inferior to PDD-assisted TUR-BT in patients with recurrent Ta low grade bladder tumor. 154 patients were randomized for PC-BT and 146 for TUR-BT. 12 months follow-up data were available for 299 patients. 12 months recurrence-free survival was 42.2% after PC-BT and 44.1% after TUR-BT, the difference 1.9% (95%CI -9.3 to 13.2) in favor of TUR-BT. Regarding 12 months recurrence-free survival, the noninferiority criterion was met. Recurrence-free survival after OPD PC-BT is noninferior to TUR-BT at 12 months follow-up. Incidence of long-term stage progression after PC-BT is noninferior to TUR-BT and very low after both treatment modalities. Treatment of recurrent Ta low grade intermediate risk bladder tumors in out-patient department with PC-BT appears to be a safe alternative to TUR-BT. Read the abstract: A prospective, comparative, within-patient controlled multicenter phase III study comparing blue light cystoscopy versus white light cystoscopy for the detection of bladder cancer using modern HD 4K equipment (Abstract session 46, Monday, 8 April, 12:30-14:00) The study enrolled a total of 158 patients in a randomized controlled trial, and 114 patients underwent Hexvix blue light cystoscopy (BLC) and were in the full analysis set. Among patients diagnosed with Ta, T1, or CIS, 42 out of 97 patients (43.3%) had at least one lesion detected by BLC but not by white light cystoscopy (WLC) (p<0.0001). Thirteen patients had CIS of which 11 (84.6%) showed additional CIS lesions. The BLC detection rates for PUNLMP, CIS, Ta, T1, and T2 ~ T4 tumors were NA, 94.7%, 100%, 98.2%, and 100%, respectively, while the WLC detection rates were NA, 42.1%, 76.1%, 91.2%, and 100%. This study confirms the superiority of HAL BLC over WLC in the detection of bladder cancer even if improved WLC using HD 4K equipment is utilized. In particular, additional high-risk difficult to see CIS lesions have been identified in 85% of all CIS patients only by HAL BLC. The quality of resection is still a key cornerstone in the treatment of NMIBC of which BLC remains a crucial part despite the further development of WLC imaging. Read the abstract: "With the rapid advancement of technologies, emerging trends towards precision medicine and introduction of novel targeted agents which are transforming bladder cancer care, there is a renewed emphasis on the importance of the diagnostic process. Getting a correct and timely diagnosis is more important than ever. It's key to optimizing the subsequent care pathways and treatment decisions," said Anders Neijber, Chief Medical Officer of Photocure. "These new results presented at EAU continue to emphasize the importance of using Blue Light Cystoscopy in the diagnosis of bladder cancer. BLC has been shown to clinically increase TURBT quality, more accurately stage disease, and enable better recurrence monitoring, supporting the long-term utility to help improve the lives of patients with bladder cancer." "Every year we see new data added to the body of evidence on Hexvix/blue light cystoscopy benefits, including with high-definition equipment. In Europe, our teams focus on helping their customers achieve the best possible image quality for BLC. We are convinced that when it comes to bladder tumor detection methods "seeing is believing", which is also our booth theme for this year's EAU. Many urologists try BLC, see what they see, and never look back", added Susanne Strauss, Vice President and General Manager Europe. *TUR-BT/TURBT: trans-urethral resection of bladder tumors Note to editors: All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA. This press release may contain product details and information which are not valid, or a product 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 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: , 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. 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 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 , , For further information, please contact: Dan Schneider President and CEO Photocure ASA Email: [email protected] Erik Dahl CFO Photocure ASA Tel: +4745055000 Email: [email protected] David Moskowitz Vice President, Investor Relations Photocure ASA Tel: +1 202 280 0888 Email: [email protected] Media and IR enquiries: Geir Bjørlo Corporate Communications (Norway) Tel: +47 91540000 Email: [email protected] This information was brought to you by Cision The following files are available for download: SOURCE Photocure