UK MHRA approves polihexanide to treat acanthamoeba keratitis

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved polihexanide, marketed as Akantior, for the treatment of acanthamoeba keratitis — a rare and painful infection of the cornea that can lead to vision loss.

The approval was granted to SIFI S.P.A. through the International Recognition Procedure (IRP), a regulatory pathway that allows the MHRA to consider the expertise of trusted international partners while retaining full decision-making authority.

What is Acanthamoeba Keratitis?

Acanthamoeba keratitis is a serious and often sight-threatening condition caused by infection of the cornea, the clear front surface of the eye. It is especially common in contact lens users and can result in severe pain, inflammation, and, in advanced cases, blindness.

How the Treatment Works

Polihexanide is administered as an eye drop solution, delivered directly into the affected eye. It acts as an anti-infective agent designed to eliminate the acanthamoeba organism responsible for the disease.

Regulatory Review and Safety Monitoring

Although this approval follows the IRP process, the MHRA conducted its own targeted assessment to ensure that the submitted data met UK standards for safety, efficacy, and quality. The agency retains full authority to reject applications if the evidence is found to be insufficient.

The safety and effectiveness of polihexanide will remain under continuous review. A complete list of side effects can be found in the Patient Information Leaflet (PIL) and the Summary of Product Characteristics (SmPC), which will be published on the MHRA website within seven days of approval.

Reporting Adverse Effects

Patients are encouraged to report any suspected side effects to the MHRA Yellow Card scheme, either through the official website at yellowcard.mhra.gov.uk or via the MHRA Yellow Card app, available on both the Google Play and Apple App Store.

About the MHRA

The MHRA is the UK’s regulatory body responsible for ensuring that medicines and medical devices are safe, effective, and of high quality. As an executive agency of the Department of Health and Social Care, the MHRA bases its decisions on scientific evidence and robust risk-benefit assessments to protect public health.

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