Photocure Expansion Accepted by FDA

Oslo Cancer Cluster member Photocure recently announced that the U.S. Food and Drug Administration (FDA) has accepted an expansion of the bladder cancer detection system “Cysview”.

The FDA has accepted a supplemental New Drug Application (NDA) for “Cysview”. Photocure, the Norwegian company behind the drug-device system, has now been allowed to expand the system to include “Flexible Cystoscopes”, these are used in the ongoing surveillance of patients with bladder cancer. According to Photocure, this is the only combination of drug and device approved for the detection of bladder cancer.

How Cysview Detects Cancer
Cysview is a method of detecting bladder cancer using photodynamic technology and is the only FDA-approved product for use with blue light cystoscopy, where a device called a cystoscope is used to detect cancer inside the bladder.

Cysview is injected into the bladder through a catheter. It accumulates differentially in malignant cells. When illuminated with blue light from the cystoscope, the cancerous lesions fluoresce red, highlighting the malignant areas.

An important Tool
Bladder cancer is one of the most expensive cancers to manage, accounting for approximately 3.7 billion USD in direct costs each year in the US. Being able to expand “Cysview” with flexible Cystoscopes will substantially decrease costs and give patients a more effective treatment. Good news for both company and bladder cancer patients.

— This approval is an important milestone for Photocure. With 1.2 million surveillance cystoscopies performed annually in the U.S., this represents a significant opportunity for the company and allows us to bring solutions to current clinical challenges, says Kjetil Hestdal M.D. Ph.D., President and CEO, Photocure.

The expanded indication includes the combination of “Cysview” with the KARL STORZ PDD Flexible Blue Light Videoscope System. The approval also expands the indication for the current rigid setting by including the detection of the pre-cancer state carcinoma in situ (CIS) in patients, as well as the repeated use of Blue Light cystoscope with Cysview.

About Photocure:

Photocure, the world leader in photodynamic technology, is a Norwegian based specialty pharmaceutical company. Photocure develop and commercialize highly selective and effective solutions in several disease areas such as bladder cancer, HPV and precancerous lesions of the cervix and acne.

Their aim is to improve patient care and quality of life by making solutions based on Photocure Technology™ accessible to patients worldwide.

Photocure was founded by the Norwegian Radium Hospital in 1997. Today, the company, headquartered in Oslo, Norway, has over 60 highly skilled employees and operates in Norway, Sweden, Denmark, Finland and the United States.