Italian ophthalmic company SIFI has received the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) marketing authorisation for Akantior (polihexanide 0.08%).
Formulated as eye drops in single-dose containers, Akantior acts on both the trophozoite and cyst forms of Acanthamoeba, providing effective monotherapy.
Acanthamoeba keratitis, a severe corneal infection primarily affecting contact lens wearers.
It is characterised by intense pain and photophobia and can lead to poor vision, blindness, or even loss of the eye if untreated.
The marketing authorisation confirms the Orphan Drug Designation and makes Akantior a new active substance for treating Acanthamoeba keratitis in individuals aged 12 and above.
It follows the Promising Innovative Medicine (PIM) designation, which means Akantior meets the criteria for addressing serious conditions with unmet needs.
Also, the designation provides significant advantages over current UK treatments and benefits that outweigh potential adverse effects.
SIFI regulatory and market access executive director Manuela Marrano said: “Granting Marketing Authorisation for Akantior and its recognition with the Positive PIM designation marks important progress in our mission to provide Acanthamoeba keratitis patients in the UK with access to this innovative treatment.
“This recognition by the MHRA underscores the potential of Akantior to address this high unmet medical need, confirming Akantior has significant benefits for patients with severely debilitating conditions.
“We also look forward to continuing our interaction with NICE to ensure the widest access in the Country for Akantior.”
The authorisation complements SIFI’s investment in developing polihexanide as an active pharmaceutical ingredient, adhering to good manufacturing practices.
It ensures the efficacy and safety levels observed in the ODAK trial and real-world evidence and represents a significant advancement for patients affected by ultra-rare eye infections.
Akantior is now the first and only approved treatment for Acanthamoeba keratitis in the UK.
The approval follows the Marketing Authorisation granted in the European Economic Area in August last year, expanding Akantior’s availability in another European market.
SIFI is currently in discussions with the National Institute of Clinical Excellence (NICE) and plans to file a full reimbursement dossier by the end of June 2025.
