The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing Authorization for AKANTIOR® (polihexanide 0.08%), making it the first and only approved treatment for Acanthamoeba keratitis in the United Kingdom. The authorization, issued on May 15, 2025, confirms the product's Orphan Drug Designation for treating this ultra-rare eye infection in adults and children from 12 years of age.
This regulatory milestone follows the MHRA's May 6th decision to award AKANTIOR® the Promising Innovative Medicine (PIM) designation, recognizing that the treatment meets all three required criteria: addressing a life-threatening or seriously debilitating condition with high unmet need, offering major advantages over current methods, and demonstrating benefits that outweigh potential adverse effects.
The Marketing Authorization also confirms AKANTIOR's New Active Substance status, acknowledging SIFI's investment in developing polihexanide as an active pharmaceutical ingredient manufactured according to good manufacturing practices.
A Breakthrough for a Devastating Eye Infection
Acanthamoeba keratitis is an ultra-rare, severe, and progressive corneal infection characterized by intense pain and photophobia. The condition primarily affects contact lens wearers and, if left untreated, can lead to poor vision, blindness, or even loss of the eye. Many patients require one or multiple corneal transplants.
AKANTIOR® represents a transformative advancement for UK patients affected by this devastating condition. The drug contains an anti-amoebic polymer that acts on both the trophozoite and cyst forms of the protozoan Acanthamoeba. Formulated as eye drops in single-dose containers at a 0.08% concentration, AKANTIOR® has demonstrated efficacy as monotherapy in clinical trials and real-world evidence.
"Granting Marketing Authorization 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," said Manuela Marrano, Executive Director, Regulatory and Market Access at SIFI. "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."
Expanding European Access
The UK approval follows AKANTIOR's Marketing Authorization in the European Economic Area granted in August 2024, expanding the treatment's availability into another major European market. SIFI, headquartered in Italy, is currently engaged with the National Institute of Clinical Excellence (NICE) and expects to file a full reimbursement dossier by the end of June 2025.
This approval represents a significant step forward in addressing the treatment gap for Acanthamoeba keratitis. Prior to AKANTIOR®, there were no approved treatments specifically developed for this condition, leaving patients with limited and often suboptimal therapeutic options.
About SIFI
SIFI is a leading international ophthalmic company headquartered in Italy, featuring an integrated business model from research and development to manufacturing and commercialization in both pharmaceutical and biomedical sectors. Founded in 1935, SIFI's mission is to improve people's lives through meaningful innovation in eye care. The company exports to more than 60 countries worldwide with a direct presence in major European markets, Mexico, and through joint ventures in China and the United Arab Emirates.
The development and approval of AKANTIOR® aligns with SIFI's long-standing commitment to addressing unmet needs in ophthalmology, particularly for rare and severe eye conditions that have historically lacked effective treatment options.
