Oslo, Norway, September 28th, 2016: Photocure ASA announced today that a study published on-line in the peer reviewed Journal of Urology, shows that there is no significant statistical difference in the frequency or grade of adverse events in patients having one Blue Light Cystoscopy with Cysview® (BLCC) versus repeat BLCC procedures. Here is a link to the abstract.
This retrospective review of 180 patients who underwent 269 BLCC procedures at two institutions in the United States compared the incidence and grade of Adverse Events (AE), after initial and subsequent BLCC procedures. 35% of the patients underwent BLCC more than once, including 2 patients who underwent BLCC five times.
-We found no statistically significant difference in AEs between those patients undergoing 1st versus two or more repeat procedures. None of the AEs were classified as probably or definitely related to BLC with Cysview. These results, along with the excellent clinical efficacy seen with BLC with Cysview, give those who manage Bladder Cancer patient’s further reassurance in using BLCC repeatedly, said Dr. Badrinath Konety, Professor and Chair Dept of Urology, University of Minnesota, Associate Director for Clinical Affairs Masonic Cancer Center.
– It is very encouraging to see more data being generated from the use of BLC with Cysview in the U.S. These data are supportive of the current clinical practice in Europe, and demonstrate that using BLC with Cysview repeatedly in the same patient has no safety concerns”, commented Kjetil Hestdal, M.D., Ph.D., President and CEO, Photocure ASA.
About Bladder Cancer
Bladder cancer is the fifth most common cancer in men with more than 330 000 new cases annually and more than 130 000 die of the disease1. It has a high recurrence rate with an average of 61% in one year and 78% over five years, making the lifetime costs of managing bladder cancer one of the highest amongst all cancers. It is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies because of the high risk of recurrence. A recent paper on the economic burden of bladder cancer across the European Union estimates that bladder cancer cost the EU 4.9 billion Euro in 20122. 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 is still in the inner layer of cells. These cancers are the most common (75%) of all bladder cancer cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. MIBC is when 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.
Hexvix®/Cysview® (hexaminolevulinate hydro-chloride) is an optical imaging agent in the diagnosis and management of non-muscle-invasive bladder cancer. It is designed to selectively target malignant cells in the bladder and induce fluorescence during a cystoscopic procedure using a blue light enabled cystoscope. Using Hexvix®/Cysview® as an adjunct to standard white light cystoscopy enables the urologist to better detect and remove lesions, leading to a reduced risk of recurrence.
Hexvix® is the tradename in Europe, Cysview® in U.S. and Canada. Hexvix® is marketed and sold by Photocure in the Nordic countries and in the US with the trade name Cysview®. Photocure has a strategic partnership with Ipsen for the commercialization of Hexvix in Europe, excluding the Nordic region. Please refer to https://www.photocure.com/Partnering-with-Photocure/Our-partners for further information on our commercial partners.