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.“