What is Cysview®?

Cysview is a pharmaceutical product that makes non-muscle invasive bladder cancer (NMIBC) tumors glow bright pink under blue light during a cystoscopy.1

 
 

Indication:


Cysview is indicated as an adjunct to White Light Cystoscopy in the diagnosis and follow up of non-muscle invasive bladder cancer, including carcinoma in situ (CIS), in patients with known or suspected bladder cancer to increase tumor detection.

Only approved cystoscopic equipment should be used, equipped with necessary filters to allow both White Light Cystoscopy (WLC) and Blue Light (wavelength 360–450nm) fluorescence Cystoscopy (BLC®). Training in Blue Light Cystoscopy with an approved Photodynamic Diagnosis (PDD) System is essential prior to the use of Cysview.

 
 
 
 

Why is there a need for Cysview®?

The standard technique for detection of bladder cancer, White Light Cystoscopy (WLC), can miss tumors that are there but not visible.2 When TURBT is performed with only white light, up to 75% of patients present with tumors at repeat TURBT.3 A complete TURBT is important in NMIBC management for accurate tumor typing, staging, grading that can impact diagnosis and the optimization of patient outcomes.2

How can Cysview® help?

BLC with Cysview:

  • Helps enhance tumor margins, increasing confidence in complete resection 4,5
  • Is the most studied enhanced cystoscopy with the only mechanism of action that targets cancer cells 1,6
 
 
 

Cysview® during TURBT

BLC with Cysview offers optimal diagnosis right from the first TURBT:

  • Detects more tumors than white light alone.1
  • Better detection may lead to appropriate risk categorization.7
 
 

Well established safety profile with over a decade of data1

The most common adverse reactions reported in patients who received Cysview (≤2% of patients):

  • Bladder Spasm
  • Dysuria
  • Bladder pain
  • Hematuria

No specific drug interaction studies have been performed.

References:

  1. Cysview Product Monograph, Canada. Mar 21, 2024.
  2. Chang SS Boorjian SA, Chou R, et al. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline.
J Urol. 2016;196(4):1021–1029. Amended 2020.
  3. Cumberbatch MGK, Foerster B, Catto JWF, et al. Repeat Transurethral Resection in Non-Muscle Invasive Bladder Cancer: A Systematic Review. Eur Urol. 2018;73(6):925–933.
  4. Daneshmand S, Patel S, Lotan Y, et al. Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multicenter Study. J Urol. 2018;199(5):1158–1165.
  5. Witjes JA, Babjuk M, Gontero P, et al. Clinical and cost effectiveness of hexaminolevulinate-guided blue-light cystoscopy: evidence review and updated expert recommendations. Eur Urol. 2014;66(5):863–871.
  6. Xiong Y, Li J, Ma S, et al. A meta-analysis of narrow band imaging for the diagnosis and therapeutic outcome of non-muscle invasive bladder cancer. PLoS One. 2017;12(2):e0170819.
  7. Richards KA, Smith ND, Steinberg GD. The Importance of Transurethral Resection of Bladder Tumor in the Management of Nonmuscle Invasive Bladder Cancer: A Systematic Review of Novel Technologies. J Urol. 2014;191(6):1655–1664.
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

How It Works

Mechanism of action pathway1

  • After instillation in the bladder, Cysview interacts with the heme biosynthetic pathway.
  • Selective intracellular accumulation of photoactive porphyrins (PAP) takes place.
  • PAPs preferentially accumulate in rapidly proliferating neoplastic cells.
  • After one hour, sufficient PAPs accumulate.
  • Under subsequent blue light illumination, neoplastic cells fluoresce bright pink.

Reference:

  1. Wachoska M, Muchowicz A, et al. Aminolevulinic Acid (ALA) as a Prodrug in Photodynamic Therapy of Cancer. Molecules. 2011;16(5):4140–4164.
 
 
 
 

How Cysview (hexaminolevulinate HCl) is metabolized in cancer cells

ALA: aminolevulinic acid; HAL: hexaminolevulinate.

See the Difference

Bladder images under white and blue light

White Light Cystoscopy

White Light Cystoscopy

Blue Light Cystoscopy

Blue Light Cystoscopy

White Light Cystoscopy

Blue Light Cystoscopy

VS

VS

VS

VS

 
 
 
 
 
 
 
 
 
 
 
 
 
 

Indication for Cysview® (hexaminolevulinate HCl)

Cysview is indicated as an adjunct to White Light Cystoscopy in the diagnosis and follow up of non-muscle invasive bladder cancer, including carcinoma in situ (CIS), in patients with known or suspected bladder cancer to increase tumor detection.

Only approved cystoscopic equipment should be used, equipped with necessary filters to allow both White Light Cystoscopy (WLC) and Blue Light (wavelength 360–450nm) fluorescence Cystoscopy (BLC®). Training in Blue Light Cystoscopy with an approved Photodynamic Diagnosis (PDD) System is essential prior to the use of Cysview.

 
 

Important Risk & Safety Information

Limitations of Use: Cysview is not a replacement for random bladder biopsies or other procedures used in the detection of bladder cancer. 


Contraindications: Cysview is contraindicated in patients with porphyria and/or hypersensitivity to the active substance or to any ingredient in the formulation or component of the container. False-positive fluorescence may result from tangential light, scope trauma from a previous cystoscopic examination, and/or bladder inflammation particularly from intravesical Bacillus Calmette–Guérin (BCG) or chemotherapy treatments. No specific drug interaction studies have been performed. 


Warnings and Precautions: Do not use in patients with gross hematuria. Do not use in patients at high risk of bladder inflammation, e.g., less than 90 days after intravesical BCG or chemotherapy. Do not use for retrograde uretero-renoscopy. Cysview has not been studied in pregnant women or pediatric populations. Cysview may not detect all malignant lesions. Very rare instances of hypersensitivity, including anaphylactic shock, have been reported during post-marketing use of Cysview. Advance life support facilities should be readily available. Biopsy/resect bladder mucosal lesions only following completion of both White Light and Blue Light Cystoscopy. 


Adverse Reactions: Most of the reported adverse reactions in clinical studies were transient and mild or moderate in intensity: bladder spasm 2.0%; dysuria 1.6%; bladder pain 1.4%; and hematuria 1.0%. The adverse reactions observed were expected based on previous experience with standard cystoscopy and TURBT procedures.

 

For additional information about Cysview, please refer to the product monograph.

 
 
 
 

BLC® and Cysview®
are registered trademarks of Photocure ASA.

 

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Information on this website is intended for Canada audiences only.
If you are from the USA, please visit Cysview.com