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Photocure ASA, the bladder cancer company, announces that its partner Asieris Pharmaceuticals communicated 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.
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.
Photocure: The bladder cancer company delivers transformative solutions to improve the lives of bladder cancer patients. Its unique technology, making cancer cells glow bright pink, has led to better health outcomes for patients worldwide.
Asieris Pharmaceuticals founded in March 2010, is a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumours and other related diseases.
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