Healthcare Industry News:  Hexvix 

Biopharmaceuticals Diagnostics Urology Oncology

 News Release - May 2, 2016

Enhanced Cystoscopy including Blue Light Cystoscopy with Cysview(R)/Hexvix(R) is Recommended in the New AUA/SUO Bladder Cancer Guideline

PRINCETON, N.J., May 2, 2016 -- (Healthcare Sales & Marketing Network) -- Photocure Inc. announced today the American Urological Association (AUA) and the Society of Urological Oncology (SUO) have included enhanced cystoscopy in the 2016 Guidelines for the management of non-muscle invasive bladder cancer (NMIBC). Enhanced cystoscopy (including Blue Light Cystoscopy with Cysview®/Hexvix®) is recommended for increasing the detection and reducing recurrence of NMIBC. The full guidelines are available AUA NMIBC Guidelines

"I am pleased that the new guideline recognizes the added benefits which BLC with Cysview provides in improved tumor detection and more complete resection of NMIBC. This is critical to reducing the risk of recurrence and progression," says Gary Steinberg, MD, FACS, The Bruce and Beth White Family Professor, Vice Chairman and Director of Urologic Oncology, University of Chicago. "I believe that urologists greatly overestimate the quality and accuracy of their cystoscopy and transurethral resections of bladder cancer tumors (TURBT) and underestimate the importance of a high quality initial TURBT. This may lead to understaging, misdiagnosis and incomplete resection. In addition, an overreliance on intravesical therapy may lead to less optimal treatment, worse cancer outcomes and increased cost."

In addition to improved detection and management of the patient, BLC with Cysview, which is used with the KARL STORZ D-Light C Photodynamic (PDD) system, leads to overall cost savings. Patients are likely to have longer recurrence-free intervals, therefore requiring less frequent TURBTs than patients who receive white light cystoscopy only.

"We are very excited that the AUA/SUO has recognized the critical role of Blue Light Cystoscopy with Cysview, based on clinical evidence, expert experience and the positive impact that enhanced cystoscopy has on the diagnosis and management of bladder cancer," says Ambaw Bellete, President, Photocure Inc. "The recommendation in the new AUA/SUO guideline now makes Hexvix/Cysview part of the major guidelines including those by the National Comprehensive Cancer Network (NCCN), the European Association of Urology (EAU) and the National Institute for Health and Care Excellence (NICE) in the UK."

About Bladder Cancer

Bladder cancer is the fifth most commonly diagnosed cancer and the fourth most common cancer found in men in the US. In 2016, it is estimated that 76,960 new cases of bladder cancer will occur along with 16,390 deaths due to bladder cancer. Risk factors for bladder cancer include advancing age, cigarette smoking, occupational exposure to dyes, tar, rubber and solvent, chronic bladder irritation and infections, and prior diagnosis of bladder cancer. Bladder cancer is one of the most expensive cancers to manage, accounting for approximately $3.7 billion in direct costs each year. 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.

About Photocure ASA

Photocure, headquartered in Oslo, Norway, is a specialty pharmaceutical company and world leader in photodynamic technology. Based on our unique proprietary Photocure Technology® platform, Photocure develops and commercializes highly selective and effective solutions within disease areas with high unmet medical need, such as bladder cancer, HPV and precancerous cervical lesions, and skin conditions. Our aim is to provide solutions which can improve health outcomes for patients worldwide. Photocure is listed on the Oslo Stock Exchange (PHO.OL). Information about Photocure is available at www.photocure.com.

Photocure Inc. is the US subsidiary of Photocure ASA, located in Princeton, NJ.

About KARL STORZ Endoscopy-America, Inc.

KARL STORZ Endoscopy-America, Inc., is an affiliate of KARL STORZ GmbH & Co. KG, an international leader for more than 70 years in reusable endoscope technology, encompassing all endoscopic specialties. Based in Tuttlingen, Germany, KARL STORZ GmbH & Co. KG is a family-owned company that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship and clinical effectiveness. For more information, call (800) 421-0837 or visit the company's website at www.karlstorz.com.

Important safety information

Cysview is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer and is not for repetitive use.

Anaphylaxis reactions including anaphylactoid shock, hypersensitivity reactions, bladder pain, cystitis, and abnormal urinalysis have been reported after administration of Cysview. The most common adverse reactions seen in clinical trials were bladder spasm, dysuria, hematuria, and bladder pain.

Cysview should not be used in patients with porphyria, gross hematuria, or with known hypersensitivity to hexaminolevulinate, or in patients receiving intravesical chemotherapy or BCG treatment within 3 months of Cysview photodynamic blue-light cystoscopy. There are no known drug interactions with hexaminolevulinate; however, no specific drug interaction studies have been performed. Using Cysview, fluorescence of non-malignant areas may occur, and Cysview may fail to detect some malignant lesions.

Safety and effectiveness have not been established in pediatric patients. Cysview should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. It is not known whether hexaminolevulinate is excreted in human milk. Because many drugs are excreted in human milk, exercise caution when Cysview is administered to nursing mothers. No clinically important differences in safety or efficacy have been observed between older and younger patients.

Cysview is approved for use with the KARL STORZ D-Light C Photodynamic Diagnostic (PDD) system. For system set up and general information for the safe use of the PDD system, please refer to the KARL STORZ instruction manuals for each of the components.

Cysview® is tradename in U.S. and Canada, Hexvix® in Europe


Source: Photocure

Issuer of this News Release is solely responsible for its content.
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