MHRA Approves Polihexanide Eye Drops for Treating Acanthamoeba Keratitis

Introduction

Acanthamoeba keratitis is an uncommon but serious infection of the cornea, often resulting in significant pain and potential vision loss. The condition is typically associated with contact lens use and can be challenging to treat.

Approval Details

On 15 May 2025, the MHRA approved polihexanide (Akantior) for treating acanthamoeba keratitis. This decision was made under the International Recognition Procedure (IRP), which allows the MHRA to consider evaluations from trusted international regulatory partners to expedite patient access to effective treatments.

Polihexanide is administered as an eye drop solution directly into the affected eye. The MHRA conducted a targeted assessment of the application, retaining the authority to reject it if the evidence was not deemed sufficiently robust.

Safety Monitoring and Reporting

As with all medicines, the MHRA will continue to monitor the safety and effectiveness of polihexanide. Patients experiencing any side effects are encouraged to consult their healthcare provider and report the incident through the MHRA’s Yellow Card scheme, accessible via their website or mobile app.

Additional Information

• The approval was granted to SIFI S.P.A.
• Comprehensive details on side effects and usage will be available in the Patient Information Leaflet (PIL) and the Summary of Product Characteristics (SmPC) on the MHRA website within seven days of approval.

Conclusion

The MHRA’s approval of polihexanide (Akantior) provides a new treatment option for patients suffering from acanthamoeba keratitis. This decision underscores the agency’s commitment to facilitating access to effective therapies for rare and challenging conditions.

Citation:
Medicines and Healthcare products Regulatory Agency. (2025, May 23). MHRA approves polihexanide to treat acanthamoeba keratitis. GOV.UK.