Cysview is an optical imaging agent designed to enhance detection of bladder cancer, in particular carcinoma in situ (CIS), it reveals lesions that may not be seen with standard white light cystoscopy. Cysview is marketed in Europe as Hexvix. Cysview is licensed by Ipsen from Photocure ASA a Norwegian pharmaceutical company that develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer and selected dermatology indications.
The importance and superior efficacy of fluorescence cystoscopy compared to white light cystoscopy alone with respect to detection of non-muscle invasive tumours and, specially CIS, is reflected in the 2008 European Association of Urology Guidelines on TaT1 (Non-muscle invasive) Bladder Cancer, which clearly endorse the technique in its recommendation: "It has been confirmed that fluorescence-guided biopsy and resection are more sensitive than conventional procedures in detecting malignant tumour, particularly CIS". On 28 May 2010 the US Food and Drug Administration (FDA) approved Cysview (hexaminolevulinate HCl) for the detection of non-muscle-invasive papillary cancer of the bladder in patients with known or suspected bladder cancer.
On 5 October 2010 it was announced a newly published publication in Journal of Urology on Hexvix. This publication shows that Cysview guided fluorescence cystoscopy (Hexvix), as an adjunct to conventional white-light cystoscopy, improves the detection of bladder cancer and reduces the rate of early tumour recurrence, compared with white-light cystoscopy alone.
On 10 November 2010 Nature (journal) published an article claiming that Photodynamic diagnosis (PDD) can improve surgical outcome on bladder cancer.
In April 2011 a new publication on Hexvix® in British Journal of Urology (BJUI) was published. This study confirm the results from a large prospective international study published in the Journal of Urology in November 2010. The results of the trial demonstrate that Hexvix identified lesions, including residual tumours, that were not detected with white light alone in 49% of the patients. It also demonstrated that the improved detection of lesions resulted in a significant reduction in tumour recurrence within 12 months.
On 12 May 2011 it was announced results from a clinical study included retrospective follow up from 526 patients in a prospective randomized Phase III trial in 28 centers in EU and North America. After a follow-up period up to 5.5 years, the number of patients who have experienced recurrence of their bladder cancer is lower, and the time it takes before the recurrence occurs is longer when they had Hexvix-guided fluorescence cystoscopy.