SIFI’s AKANTIOR Receives EU Approval: Revolutionizing Acanthamoeba Keratitis Treatment

SIFI, an Italian ophthalmic company, has achieved a significant milestone with the European Commission’s approval of AKANTIOR for the treatment of acanthamoeba keratitis (AK). This first-of-its-kind therapy in Europe is set to launch commercially in Germany by the fourth quarter of 2024, with subsequent rollouts in other major European markets.

Acanthamoeba keratitis is an ultra-rare and sight-threatening corneal infection caused by the acanthamoeba protozoan, primarily affecting contact lens wearers. The infection leads to intense pain and photophobia, making timely and effective treatment crucial.

AKANTIOR, an anti-amoebic polymer, effectively targets both trophozoites and cysts stages of acanthamoeba, offering a comprehensive treatment option as a monotherapy administered through single-dose eye drops. The US Food and Drug Administration (FDA) previously granted orphan drug designation for AKANTIOR, further validating its clinical importance.

Fabrizio Chines, chairman and CEO of SIFI, expressed the significance of the approval: “The 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 European Medicines Agency and the FDA.”