#United Kingdom #AKANTIOR #SIFI #Acanthamoeba #Catania

Introduction

In a significant advancement for ophthalmic treatments, SIFI, a leading international ophthalmic company, has obtained marketing authorization for its groundbreaking product AKANTIOR® (polihexanide 0.08%) from the UK's Medicines and Healthcare products Regulatory Agency (MHRA). This authorization confirms the orphan drug status of AKANTIOR® for treating Acanthamoeba keratitis, a rare but devastating eye infection that can lead to blindness if left untreated, particularly in individuals who wear contact lenses.

Recent Developments

On May 6, 2025, the MHRA designated AKANTIOR® as a Promising Innovative Medicine (PIM), recognizing its potential to address significant unmet medical needs. The product was then granted full marketing authorization on May 15, 2025.

Why the Approval Matters

SIFI’s latest approval is crucial for several reasons:

• - Unique Treatment: AKANTIOR® becomes the first and only approved treatment for Acanthamoeba keratitis in the UK, presenting a major breakthrough for patients battling this condition.
• - Efficacy and Safety: The marketing approval confirms AKANTIOR® as a new active substance, acknowledging the comprehensive research and investments undertaken by SIFI to develop this innovative treatment in accordance with Good Manufacturing Practices (GMP).
• - Patient Impact: The MHRA highlighted that the criteria for PIM designation are met; Acanthamoeba keratitis is often life-threatening and can severely impair quality of life, with no alternative treatments available that can match its efficacy.

The Science Behind AKANTIOR®

AKANTIOR® is specifically formulated as a 0.08% ophthalmic solution utilizing a unique amebicidal polymer that targets both the trophozoite and cyst forms of the Acanthamoeba. Its formulation allows for effective monotherapy, which is particularly crucial for patients who may struggle with more complex treatment regimens. This innovation addresses a pressing need in the marketplace; existing treatments often fall short and may come with significant side effects or treatment limitations.

Understanding Acanthamoeba Keratitis

Acanthamoeba keratitis is a rare but severe corneal infection, often associated with individuals who wear contact lenses. The disease is characterized by severe pain, photophobia, and can result in significant impairment, even blindness. Treatment usually necessitates corneal transplants, reflecting the severity of this infection. With AKANTIOR®, patients can access a targeted therapy designed to efficiently combat this disorder, enhancing their chances of recovery without the need for extensive surgical procedures.

Future Outlook and Regulatory Engagement

Following this milestone, SIFI is actively engaging with the National Institute for Health and Care Excellence (NICE) in the UK and intends to submit a full reimbursement dossier by June 2025. Such efforts are essential to ensure that AKANTIOR® becomes widely accessible to patients in the UK, facilitating greater health equity across the region.

Quotes from SIFI

Manuela Marrano, SIFI's Executive Director of Regulatory Affairs and Market Access, stated: "The marketing authorization and recognition of the PIM designation for AKANTIOR® marks a significant step in our mission to provide innovative solutions for patients suffering from Acanthamoeba keratitis in the UK. We are eager to continue our dialogue with NICE to maximize patient access to this important therapy."

Conclusion

The approval of AKANTIOR® in the UK is more than just a regulatory success; it represents a beacon of hope for countless patients grappling with the debilitating effects of Acanthamoeba keratitis. As SIFI moves forward with its plans for broader access and reimbursement, it reinforces its commitment to improving patient outcomes through innovative ophthalmic solutions. With this new treatment now available, the path towards recovery for many is brighter than ever.

For more details on SIFI and its innovative products, visit www.sifigroup.com.