An ultra-rare, sight-threatening corneal infection, acanthamoeba keratitis causes intense pain and photophobia. Credit: Jo Panuwat D/Shutterstock.

Italian ophthalmic company SIFI has received European Commission (EC) approval for AKANTIOR (polihexanide) to treat acanthamoeba keratitis (AK), a rare and severe corneal infection.

The asset is the first therapy approved for AK in Europe.

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AKANTIOR targets both adults and children aged 12 years and above.

Its commercial launch is set to begin in Germany in the fourth quarter of 2024, with subsequent rollouts in France, Italy, Romania, Spain, Türkiye and the UK.

The launches are contingent on each country’s regulatory and reimbursement processes.

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SIFI has also partnered with Avanzanite to introduce AKANTIOR in other European markets.

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AKANTIOR (polihexanide 0.08%) is an anti-amoebic polymer effective against both the trophozoites and cysts stages of acanthamoeba.

It can be used as a monotherapy in the form of single-dose eye drops.

The US Food and Drug Administration (FDA) granted orphan drug designation for AKANTIOR.

An ultra-rare, sight-threatening corneal infection, AK causes intense pain and photophobia.

The infection primarily affects those who wear contact lenses and is caused by the acanthamoeba protozoan.

SIFI chairman and CEO Fabrizio Chines stated: “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.”