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Asieris: Cevira (APL-1702) NDA
Advances to Second Round of
Technical Review
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 communication with 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: http://asieris.com/asieris-apl-1702-nda-advances-to-
second-round-of-technical-review/
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
Note to editors:
All trademarks mentioned in this release are protected by law and are registered trademarks of
Photocure ASA.
This press release may contain product details and information which are not valid, or a product is not
accessible, in your country. Please be aware that Photocure does not take any responsibility for
accessing such information which may not comply with any legal process, regulation, registration or
usage in the country of your origin.
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.
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.
