SIFI receives Marketing Authorisation and Promising Innovative Medicine Designation for AKANTIOR® in the UK

• MHRA granted on 6^th May the Promising Innovative Medicine (PIM) Designation
• MHRA granted on 15^th May the Marketing Authorisation, confirming the Orphan Drug Designation and the New Active Substance status

CATANIA, Italy, May 19, 2025 /PRNewswire/ -- SIFI, a leading international ophthalmic company, today announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted the Marketing Authorization for AKANTIOR® (polihexanide 0.08%) confirming the Orphan Drug Designation of the product in the treatment of Acanthamoeba keratitis in adults and children from 12 years of age.

The Marketing Authorisation confirms the New Active Substance status, recognizing the investments made by SIFI in developing polihexanide as an active pharmaceutical ingredient according to good manufacturing practices, a key element in ensuring the level of efficacy and safety seen in the ODAK trial and real world evidence.

A few days before, the MHRA also awarded AKANTIOR the Promising Innovative Medicine (PIM) designation, confirming that AKANTIOR® meets all three of the following criteria established by the MHRA:

1. The condition is life-threatening or seriously debilitating with special emphasis on patient quality of life, and there is high unmet need as there is no method of treatment available or existing methods have serious limitations.
2. The medicinal product is likely to offer a major advantage over current methods used in the UK.
3. The benefits of the medicinal products are likely to outweigh potential adverse effects.

AKANTIOR® becomes the first and only approved treatment for Acanthamoeba keratitis in the United Kingdom, representing a transformative step for UK patients affected by Acanthamoeba keratitis, an ultra-rare and devastating eye infection that can lead to blindness if left untreated.

Following the Marketing Authorization in the European Economic Area granted in August 2024, MHRA approval expands the availability into another major European market of AKANTIOR®.

SIFI is currently engaged with the National Institute of Clinical Excellence (NICE) and expects to file a full reimbursement dossier by end of June 2025.

"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, 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. We also look forward to continuing our interaction with NICE to ensure the widest access in the Country for AKANTIOR."

AKANTIOR® (polihexanide 0.08%) is the first and only approved drug specifically developed for the treatment of Acanthamoeba keratitis in the world. It contains an anti-amoebic polymer that acts on both the trophozoite and cyst forms of the protozoan acanthamoeba. AKANTIOR® is formulated as eye drops in single-dose containers at a 0.08% concentration and it is effective as monotherapy.

Acanthamoeba keratitis is an ultra-rare, severe, and progressive corneal infection characterized by intense pain and photophobia. It primarily affects contact lens wearers and, if left untreated, can lead to poor vision, blindness, or even loss of the eye. The condition often requires one or multiple corneal transplants.

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.

For more information, visit www.sifigroup.com