Asieris Announces EMA Acceptance for CEVIRA Marketing Authorization in Europe
On February 27, 2026, Photocure ASA, a prominent player in the bladder cancer treatment arena, revealed that its partner, Asieris Pharmaceuticals, has received significant news regarding CEVIRA (APL-1702). The European Medicines Agency (EMA) has accepted Asieris’s Marketing Authorization Application (MAA) for CEVIRA, marking an important milestone for the treatment of high-grade squamous intraepithelial lesions (HSIL). CEVIRA is noteworthy as it represents a novel approach in photodynamic therapy, combining a light-activated drug application with a medical device in one compact solution.
CEVIRA utilizes hexaminolevulinate hydrochloride ointment delivered through a disposable cervical light applicator, which enables clinicians to administer the treatment precisely where it is needed. This innovation is a significant advancement in achieving localized drug delivery, featuring a cold light source that is designed for intra-cavity application. This technology paves the way for a new treatment paradigm, particularly for patients suffering from HSIL.
The foundation for the EMA's acceptance of the MAA lies in the results from an extensive multinational Phase III clinical trial that engaged over 20% of participants from Europe. This large-scale trial confirmed the efficacy and safety of the APL-1702 product, which is specifically aimed at offering a non-surgical treatment option for patients aged 18 and older who present high-grade squamous intraepithelial lesions but do not have carcinoma in situ.
The development of CEVIRA was initiated by Photocure, which navigated through the initial Phase I and Phase II clinical trials. In 2019, Photocure partnered with Asieris Pharmaceuticals and licensed the global rights for the product’s development and commercialization. Following this, Asieris launched the Phase III trial in November 2020, ultimately achieving its primary endpoint in September 2023.
Photocure has long been a leader in the bladder cancer sector, with its commitment to improving patient outcomes through innovative technologies. Their proprietary approach, which allows cancer cells to emit a pink glow, has led to improved visibility during surgical procedures, translating into better health outcomes for patients worldwide. Headquartered in Oslo, Norway, and listed on the Oslo Stock Exchange, Photocure is dedicated to changing the landscape of cancer treatment.
Asieris Pharmaceuticals, a biopharmaceutical company established in March 2010, focuses on developing and commercializing cutting-edge therapies for genitourinary tumors and related diseases. With CEVIRA, Asieris aims not only at enhancing the efficacy of HSIL treatment but also at shaping a future where patients have access to safer, non-invasive options.
With the EMA's approval, both Photocure and Asieris take a giant leap towards making CEVIRA available to healthcare providers and patients throughout Europe. This acceptance is not only a testament to the rigorous research and clinical trials these companies have undertaken but also a beacon of hope for patients awaiting innovative treatment solutions in their fight against HSIL. Keep an eye on further developments as these integral partners continue to work towards making CEVIRA a viable option for those affected by high-grade lesions.
CEVIRA utilizes hexaminolevulinate hydrochloride ointment delivered through a disposable cervical light applicator, which enables clinicians to administer the treatment precisely where it is needed. This innovation is a significant advancement in achieving localized drug delivery, featuring a cold light source that is designed for intra-cavity application. This technology paves the way for a new treatment paradigm, particularly for patients suffering from HSIL.
The foundation for the EMA's acceptance of the MAA lies in the results from an extensive multinational Phase III clinical trial that engaged over 20% of participants from Europe. This large-scale trial confirmed the efficacy and safety of the APL-1702 product, which is specifically aimed at offering a non-surgical treatment option for patients aged 18 and older who present high-grade squamous intraepithelial lesions but do not have carcinoma in situ.
The development of CEVIRA was initiated by Photocure, which navigated through the initial Phase I and Phase II clinical trials. In 2019, Photocure partnered with Asieris Pharmaceuticals and licensed the global rights for the product’s development and commercialization. Following this, Asieris launched the Phase III trial in November 2020, ultimately achieving its primary endpoint in September 2023.
Photocure has long been a leader in the bladder cancer sector, with its commitment to improving patient outcomes through innovative technologies. Their proprietary approach, which allows cancer cells to emit a pink glow, has led to improved visibility during surgical procedures, translating into better health outcomes for patients worldwide. Headquartered in Oslo, Norway, and listed on the Oslo Stock Exchange, Photocure is dedicated to changing the landscape of cancer treatment.
Asieris Pharmaceuticals, a biopharmaceutical company established in March 2010, focuses on developing and commercializing cutting-edge therapies for genitourinary tumors and related diseases. With CEVIRA, Asieris aims not only at enhancing the efficacy of HSIL treatment but also at shaping a future where patients have access to safer, non-invasive options.
With the EMA's approval, both Photocure and Asieris take a giant leap towards making CEVIRA available to healthcare providers and patients throughout Europe. This acceptance is not only a testament to the rigorous research and clinical trials these companies have undertaken but also a beacon of hope for patients awaiting innovative treatment solutions in their fight against HSIL. Keep an eye on further developments as these integral partners continue to work towards making CEVIRA a viable option for those affected by high-grade lesions.
Topics Health）
【About Using Articles】
You can freely use the title and article content by linking to the page where the article is posted.
※ Images cannot be used.
【About Links】
Links are free to use.