European Commission Approves Akantior as First Treatment for Acanthamoeba Keratitis

SIFI, a leading international ophthalmic company, announced that the European Commission has approved AKANTIOR® (polihexanide) for treating acanthamoeba keratitis (AK) in adults and children aged 12 and older. This makes AKANTIOR the first and only approved therapy for AK in Europe, following 15 years of dedicated research and development. The approval also confirms the product’s orphan status.

Fabrizio Chines, Chairman and CEO of SIFI, stated, “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.”

Understanding Acanthamoeba Keratitis

Acanthamoeba keratitis is a rare, severe, and progressive corneal infection caused by the free-living amoeba Acanthamoeba, primarily affecting contact lens wearers. The disease is characterized by intense pain, photophobia, and can lead to blindness. AKANTIOR provides a new global standard of care, filling a significant treatment gap.

Clinical Success of AKANTIOR

AKANTIOR’s efficacy was demonstrated in the pivotal Phase 3 ODAK trial, which showed that when used as monotherapy, it achieved medical cure rates of over 86%. The trial, led by Professor John Dart of Moorfields Eye Hospital and UCL Institute of Ophthalmology, highlights AKANTIOR as a significant improvement over previous treatments, offering a standardized protocol that can prevent blindness and save eyes. Professor Dart remarked, “AKANTIOR, when used as monotherapy with the trial’s treatment protocol, achieves medical cure rates of over 86% and is set to become the standard of care for this severe and debilitating disease.”

Strategic Partnership and Market Launch

The approval of AKANTIOR also strengthens SIFI’s partnership with Avanzanite. Through a license and supply agreement, Avanzanite has been granted exclusive rights to commercialize AKANTIOR across the European Economic Area and Switzerland. SIFI plans to launch AKANTIOR commercially in Germany later this year, followed by other European markets, including France, Italy, Romania, Spain, the UK, and Turkey. This collaboration will expand access to AKANTIOR across a population of 610 million people.

Juliette Vila Sinclair Spence, Chairwoman of the AK Eye Foundation, commented on the milestone: “This milestone represents a significant step towards providing fair healthcare to all AK Warriors, giving them hope for a brighter future.”

For more details on the partnership, see the full story here.

About AKANTIOR®

AKANTIOR (polihexanide 0.08%) is the world’s first approved drug for treating acanthamoeba keratitis. This anti-amoebic polymer targets both trophozoites and cysts of Acanthamoeba and is delivered as monotherapy eye drops in single-dose containers. Alongside European Commission approval, the FDA has also granted AKANTIOR Orphan Drug Designation for AK treatment.

SIFI is committed to further developing polihexanide for other corneal infections, including fungal keratitis, where orphan drug designation has also been obtained from both the EMA and FDA.