SIFI's AKANTIOR® Receives Promising Innovative Medicine Designation in the UK
In a remarkable development for the field of ophthalmology, SIFI, a prominent international company, has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization and designated its eye drop product, AKANTIOR® (0.08% polyhexanide), as a Promising Innovative Medicine. This designation was awarded on May 6, 2025, followed by the marketing authorization confirmation on May 15, recognizing AKANTIOR® as an orphan drug for treating Acanthamoeba keratitis in both adults and children aged 12 and older.
AKANTIOR® represents a groundbreaking advancement, being the first and only treatment officially approved for Acanthamoeba keratitis in the UK. This rare and severe eye infection can lead to blindness if not treated promptly and effectively. The approval by MHRA demonstrates the rigorous validation of polyhexanide's active pharmaceutical ingredient, underscoring the significant investments SIFI has made in its development under stringent good manufacturing practices ensuring both efficacy and safety.
The designation of Promising Innovative Medicine (PIM) confirms that AKANTIOR® meets critical criteria set by the MHRA. Specifically, the agency identified that the condition poses a life-threatening risk or severely debilitating impact on quality of life, highlighting a substantial unmet medical need due to the absence of adequate existing treatments. Furthermore, it was assessed that AKANTIOR® is likely to offer considerable advantages over the currently utilized treatment methods in the UK, with the expected benefits outweighing potential adverse effects.
This pivotal step not only enhances treatment options for patients afflicted with Acanthamoeba keratitis in the UK but also expands the reach of AKANTIOR®, following its earlier approval in the European Economic Area in August 2024. SIFI is currently engaging with the National Institute for Health and Care Excellence (NICE), with plans to submit a full reimbursement dossier by the end of June 2025.
Manuela Marrano, SIFI's Executive Director of Regulatory Affairs and Market Access, expressed her enthusiasm, stating, “The granting of marketing authorization for AKANTIOR® and its recognition with a Positive PIM designation marks a significant advancement in our mission to provide UK patients with Acanthamoeba keratitis access to this innovative treatment. This recognition underscores the potential of AKANTIOR® to address a vital medical unmet need, confirming that it offers substantial benefits to patients suffering from severely debilitating conditions. We look forward to continuing our collaboration with NICE to ensure the widest possible access to AKANTIOR in the country.”
About AKANTIOR®: The product is renowned for its unique formulation specifically developed for treating Acanthamoeba keratitis. It leverages an anti-amoebic polymer that targets both the trophozoite and cyst stages of the Acanthamoeba protozoan. With a concentration of 0.08%, AKANTIOR® is offered in single-dose eye drop vials and demonstrates effectiveness as a standalone therapy. Acanthamoeba keratitis, primarily affecting contact lens users, manifests as an extremely rare but serious corneal infection, characterized by intense pain and light sensitivity. Untreated, it can lead to poor vision, blindness, or even loss of the eye, often necessitating one or several corneal transplants.
As a leader in the ophthalmological sector, SIFI has been at the forefront of innovative research and development in eye care since its establishment in 1935. The company operates a fully integrated business model encompassing R&D, manufacturing, and marketing across the pharmaceutical and biomedical sectors. SIFI proudly exports its solutions to over 60 countries worldwide, marking its presence in key European markets, Mexico, and through joint ventures in China and the UAE. For further details, visit www.sifigroup.com.
AKANTIOR® represents a groundbreaking advancement, being the first and only treatment officially approved for Acanthamoeba keratitis in the UK. This rare and severe eye infection can lead to blindness if not treated promptly and effectively. The approval by MHRA demonstrates the rigorous validation of polyhexanide's active pharmaceutical ingredient, underscoring the significant investments SIFI has made in its development under stringent good manufacturing practices ensuring both efficacy and safety.
The designation of Promising Innovative Medicine (PIM) confirms that AKANTIOR® meets critical criteria set by the MHRA. Specifically, the agency identified that the condition poses a life-threatening risk or severely debilitating impact on quality of life, highlighting a substantial unmet medical need due to the absence of adequate existing treatments. Furthermore, it was assessed that AKANTIOR® is likely to offer considerable advantages over the currently utilized treatment methods in the UK, with the expected benefits outweighing potential adverse effects.
This pivotal step not only enhances treatment options for patients afflicted with Acanthamoeba keratitis in the UK but also expands the reach of AKANTIOR®, following its earlier approval in the European Economic Area in August 2024. SIFI is currently engaging with the National Institute for Health and Care Excellence (NICE), with plans to submit a full reimbursement dossier by the end of June 2025.
Manuela Marrano, SIFI's Executive Director of Regulatory Affairs and Market Access, expressed her enthusiasm, stating, “The granting of marketing authorization for AKANTIOR® and its recognition with a Positive PIM designation marks a significant advancement in our mission to provide UK patients with Acanthamoeba keratitis access to this innovative treatment. This recognition underscores the potential of AKANTIOR® to address a vital medical unmet need, confirming that it offers substantial benefits to patients suffering from severely debilitating conditions. We look forward to continuing our collaboration with NICE to ensure the widest possible access to AKANTIOR in the country.”
About AKANTIOR®: The product is renowned for its unique formulation specifically developed for treating Acanthamoeba keratitis. It leverages an anti-amoebic polymer that targets both the trophozoite and cyst stages of the Acanthamoeba protozoan. With a concentration of 0.08%, AKANTIOR® is offered in single-dose eye drop vials and demonstrates effectiveness as a standalone therapy. Acanthamoeba keratitis, primarily affecting contact lens users, manifests as an extremely rare but serious corneal infection, characterized by intense pain and light sensitivity. Untreated, it can lead to poor vision, blindness, or even loss of the eye, often necessitating one or several corneal transplants.
As a leader in the ophthalmological sector, SIFI has been at the forefront of innovative research and development in eye care since its establishment in 1935. The company operates a fully integrated business model encompassing R&D, manufacturing, and marketing across the pharmaceutical and biomedical sectors. SIFI proudly exports its solutions to over 60 countries worldwide, marking its presence in key European markets, Mexico, and through joint ventures in China and the UAE. For further details, visit www.sifigroup.com.
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