Press release - Oslo, Norway, August 4, 2025: Photocure ASA (OSE: PHO), the
Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE:
688176) communicated today that its photodynamic drug-device combination
product candidate Cevira (APL-1702), has advanced to the second round of
technical review.
The company will maintain proactive communicationwith the Center for Drug
Evaluation (CDE) to expedite the New Drug Application (NDA) review process.
Cevira (APL-1702) is a photodynamic drug-device combination product in
development for the non-surgical treatment of high-grade squamous
intraepithelial lesions (HSIL), licensed to Asieris by Photocure.
Read Asieris' full media release here: https://asieris.com/asieris-apl-1702-nda
-advances-to-second-round-of-technical
-review/ (https://eur01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fasie
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For more information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Email: ds@photocure.com
Erik Dahl
CFO
Photocure ASA
Tel: +47 45055000
Email: ed@photocure.com
Media and IR enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: geir.bjorlo@corpcom.no
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About Cevira®
Cevira® (APL-1702) is a photodynamic drug-device combination product in
development. Based on the principles of photodynamic therapy, the Cevira product
aims to use a photosensitizer in combination with light activation to produce a
therapeutic effect as a non-surgical treatment of high-grade squamous
intraepithelial lesions (HSIL) in patients aged 18 years and above, excluding
carcinoma in situ.
Photocure developed Cevira through Phase I and Phase II trials, and the global
rights for development and commercialization were out-licensed to Asieris
Meditech Co., Ltd in 2019. In November 2020 Asieris initiated the phase III
clinical trial for APL-1702 (Cevira) which achieved its primary endpoint in
September 2023, Clinical trial number:
NCT04484415 (https://classic.clinicaltrials.gov/ct2/show/NCT04484415).
About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, making
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo
Stock Exchange (OSE: PHO). For more information, please visit us at
www.photocure.com/news
About Asieris
Asieris Pharmaceuticals(688176.SH), founded in March 2010, is a global biopharma
company specializing in discovering, developing and commercializing innovative
drugs for the treatment of genitourinary tumors and other related diseases.