Photocure partner Asieris announces that EMA has accepted Marketing Authorization Application for CEVIRA in Europe
OSLO, Norway, Feb. 27, 2026 /PRNewswire/ -- Photocure ASA (OSE: PHO), the Bladder Cancer Company, announces that its partner Asieris Pharmaceuticals (SSE: 688176) communicated today that its marketing authorization application (MAA) for Cevira® (APL-1702) for the treatment of high-grade squamous intraepithelial lesions (HSIL) has been accepted by the European Medicines Agency (EMA).
Asieris' media release states about APL-1702, the first-in-class photodynamic therapy product: "As a drug-device combination, it integrates hexaminolevulinate hydrochloride ointment with a disposable cervical light applicator. Its innovative design enables localized drug administration and features an intra-cavity cold light source, representing a paradigm shift in the treatment approach.
The MAA submission to the EMA is primarily supported by results from the international multicenter Phase III clinical trial of APL-1702, which enrolled over 20% European patients."
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-announces-european-medicines-agency-accepts-marketing-authorization-application-for-apl-1702/
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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.
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 (SSE: 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.
For more information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Email: [email protected]
Erik Dahl
CFO
Photocure ASA
Tel: +47 45055000
Email: [email protected]
Priyam Shah
Vice President Investor Relations
Tel : +17176815072
Email: [email protected]
Media enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: [email protected]
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