The European Commission has approved the use of polihexanide (trade name Akantior) for the treatment of acanthamoeba keratitis (Ak).
The treatment, developed by Sifi of Catania, is intended for adults and children aged twelve and over and is – according to information reported by the company that produces it – the first and only therapy approved in Europe for people affected by this disease. The orphan drug status has been confirmed.
The disease and its impact
Ak is a very rare, serious, progressive and sight-threatening corneal infection characterized by severe pain and photophobia. The disease is caused by a free-living amoeba, acanthamoeba, and primarily affects contact lens wearers.
Towards a global standard of care
“This approval is an important step towards creating a new global standard of care for AK patients and builds on 15 years of research and development,” said Fabrizio Chines, President and CEO of Sifi. “For the first time in Europe, AK patients have an approved therapy, marking a new era in the treatment of this potentially blinding disease. Akantior is the first and only approved drug for AK and our team is committed to developing polihexanide in other infectious diseases of the cornea, such as fungal keratitis, for which we have obtained orphan drug designation from the EMA and the FDA.”
Significant recovery rates
“Akantior, used as monotherapy with the study treatment protocol, achieves medical cure rates greater than 86% and is expected to become the standard of care for this serious and debilitating disease,” said the John Dart, of Moorfields Eye Hospital and UCL Institute of Ophthalmology, who was principal investigator of the Phase III Odak study.
The study supporting the approval
“After 15 years of research and efforts by Sifi, culminating in the Phase III clinical study, polihexanide 0.08% has been approved by the European Medicines Agency and the European Commission as the first authorised treatment for acanthamoeba keratitis. This innovation offers a significant improvement over current treatment options and has the potential to prevent blindness and save eyes. As the only approved therapy, it has been recommended for use with the detailed treatment administration protocol used in the Phase 3 study, which eliminates the need for variable and individualised administration of the treatment currently used for patients, providing an effective and standardised approach that can be followed by any physician and which has been shown to be effective, not only in the study, but also in the current compassionate use programme outside of the more rigorous context of the study”.
A new hope of treatment for patients
“With the approval of Akantior, AK patients (also known as AK warriors) are now one step closer to having access to the best possible treatment in the EU. This milestone represents a significant step towards providing equitable healthcare to all AK warriors, giving them hope for a brighter future,” he added. Juliette Vila Sinclair Spencerepresentative of patients affected by this rare disease and president and founder of the AK Eye Foundationthe first global foundation dedicated exclusively to this pathology.
Next steps
In Europe, Sifi plans to launch its first commercial launch in Germany in the last quarter of this year, followed by other markets based on local regulatory, health technology assessment and reimbursement timelines, including France, Italy, Romania, Spain, the United Kingdom and Turkey, for a total population of 430 million people, and by Avanzanite, its commercial partner, in other European countries, for an additional population of 180 million people. Based on scientific publications, the incidence of acanthamoeba keratitis is estimated to be between 1 and 4 patients per million inhabitants.
