International ophthalmic company SIFI announced on Monday that it has received approval from the European Commission for AKANTIOR (polihexanide) intended for the treatment of acanthamoeba keratitis (AK) in adults and children from 12 years of age and confirmed the product's orphan status.

AKANTIOR is the first and only approved therapy for people suffering from AK in Europe. AK is an ultra-rare, severe, progressive and sight threatening corneal infection characterised by intense pain and photophobia.

The company is planning to commence its first commercial launch in Germany during the last quarter of 2024, and then in other markets based on local regulatory, healthcare technology assessment and reimbursement process timelines, including France, Italy, Romania, Spain, United Kingdom and Turkey, and by Avanzanite, its commercial partner, in other European Countries.

Fabrizio Chines, SIFI chairman and CEO, said, 'Today's approval represents an important step towards delivering a new global standard of care for patients with AK and builds on 15 years of research and development. For the first time in Europe AK patients have an approved therapy, marking a new era in the treatment of this disease, which may lead to blindness. AKANTIOR is the first and only approved medicine for AK, and our team is committed to developing polihexanide in other corneal infectious diseases, such as fungal keratitis, where we obtained orphan drug designation from the EMA and the FDA.'