General News
The European Commission has approved AKANTIOR®
A new treatment for acanthamoeba keratitis
The European Commission has approved AKANTIOR®, the first treatment for acanthamoeba keratitis, a rare sight-threatening eye infection, after 15 years of research supported by UCL and Moorfields Eye Hospital.
Developed by international ophthalmic company SIFI S.p.A., AKANTIOR is the first European-approved treatment for adults and children from 12 years of age suffering with acanthamoeba keratitis (AK).
AK is a rare, severe, progressive and sight threatening corneal infection. This condition results in inflammation of the eye’s clear protective outer layer (the cornea), often causing intense levels of pain as well as light sensitivity. AK is caused by a type of microscopic free-living amoeba, and primarily affects contact lens wearers.
This approval follows a 2023 clinical trial involving 127 people being treated for AK at six hospitals across Europe (in England, Italy and Poland). The trial found that AKANTIOR (a 0.08% concentration of polihexanide) achieved medical cure rates of over 86% when used with the detailed drug delivery protocol.
Professor John Dart (UCL Institute of Ophthalmology and Moorfields Eye Hospital NHS Foundation Trust), who was Principal Investigator of the Phase 3 clinical trial said:
“After 15 years of research and effort development by SIFI, culminating in the pivotal Phase 3 clinical trial, polihexanide 0.08% has now been approved by the European Medicines Agency and European Commission as the first licensed treatment for acanthamoeba keratitis. This breakthrough offers 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 delivery protocol used in the Phase 3 trial, which eliminates the need for the variable individualised treatment delivery currently used for patients, providing an effective standardised approach that can be followed by any clinician and which has been shown to be effective, not only in the Trial, but also in the current compassionate use program outside the more stringent Trial setting.”
The MHRA has not yet approved the treatment in the UK.
