EMA Accepts Marketing Authorization Application for Cevira, First-in-Class Photodynamic Therapy for Cervical Lesions
核心洞察
The European Medicines Agency has accepted Asieris Pharmaceuticals (搜索)' marketing authorization application for Cevira (APL-1702), a first-in-class photodynamic therapy for treating high-grade squamous intraepithelial lesions.
Cevira represents a paradigm shift as a drug-device combination integrating hexaminolevulinate hydrochloride ointment with a disposable cervical light applicator for non-surgical treatment.
The application is supported by results from an international multicenter Phase III clinical trial that enrolled over 20% European patients and achieved its primary endpoint in September 2023.
The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for Cevira® (APL-1702), a first-in-class photodynamic therapy for treating high-grade squamous intraepithelial lesions (HSIL). Asieris Pharmaceuticals (搜索) (SSE: 688176), partner to Photocure ASA (OSE: PHO), announced the regulatory milestone on February 27, 2026.
Novel Drug-Device Combination Approach
Cevira represents a significant advancement in cervical lesion treatment as a drug-device combination that integrates hexaminolevulinate hydrochloride ointment with a disposable cervical light applicator. According to Asieris, the innovative design enables localized drug administration and features an intra-cavity cold light source, representing a paradigm shift in the treatment approach for HSIL.
The photodynamic therapy product is designed as a non-surgical treatment option for high-grade squamous intraepithelial lesions in patients aged 18 years and above, excluding carcinoma in situ. Based on photodynamic therapy principles, Cevira aims to use a photosensitizer in combination with light activation to produce a therapeutic effect.
Phase III Trial Results Support Application
The MAA submission to the EMA is primarily supported by results from an international multicenter Phase III clinical trial of APL-1702, which enrolled over 20% European patients. The Phase III clinical trial, initiated by Asieris in November 2020, achieved its primary endpoint in September 2023 under clinical trial number NCT04484415.
Photocure originally developed Cevira through Phase I and Phase II trials before out-licensing the global rights for development and commercialization to Asieris Meditech Co., Ltd (搜索) in 2019.
Partnership and Development Timeline
Photocure ASA, known as "The Bladder Cancer Company," developed the foundational technology that makes cancer cells glow bright pink, leading to improved health outcomes for patients worldwide. The Oslo-based company, listed on the Oslo Stock Exchange, partnered with Asieris Pharmaceuticals (搜索) to advance Cevira's development.
Asieris Pharmaceuticals (搜索), founded in March 2010 and listed on the Shanghai Stock Exchange (SSE: 688176.SH), specializes in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases.