#United Kingdom #AKANTIOR #SIFI #Acanthamoeba #Catania

SIFI's AKANTIOR® Achieves Key Approvals in the UK

SIFI, a renowned international company specializing in ophthalmology, proudly announces the successful acquisition of Marketing Authorization for its product AKANTIOR® from the UK's Medicines and Healthcare products Regulatory Agency (MHRA). This recent approval is a significant milestone, particularly for individuals suffering from Acanthamoeba keratitis, a rare but severe eye condition.

Marketing Authorization and PIM Designation

On May 15, 2025, the MHRA granted this Marketing Authorization, confirming AKANTIOR® as a designated Orphan Drug and affirming its New Active Substance status. These approvals are paramount, as they recognize the extensive research and development efforts that SIFI has invested in creating the effective ophthalmic solution composed of polihexanide 0.08%.

Additionally, only a few days prior, AKANTIOR® was awarded the Promising Innovative Medicine (PIM) designation, which signifies that it meets stringent criteria set by the MHRA. This designation indicates that AKANTIOR® is:

• - Aimed at treating a life-threatening condition or one that significantly compromises the quality of life of patients, where current treatment options are either limited or entirely unavailable.
• - Expected to offer considerable advantages over the current treatment methods in the UK.
• - Balanced with benefits that outweigh any foreseeable adverse effects.

Transformative Impact on Treatment

With this authorization, AKANTIOR® stands as the first and only approved treatment specifically for Acanthamoeba keratitis in the UK. This revolutionary step signifies hope for patients grappling with this disease — an ultra-rare eye infection that, if neglected, can lead to blindness. The infection predominantly affects contact lens users and is characterized by extreme discomfort and complications that may necessitate a corneal transplant.

SIFI has previously secured similar marketing authorization within the European Economic Area in August 2024. With the recent MHRA endorsement, AKANTIOR® is set to expand its reach even further into another critical European market.

Next Steps for SIFI

SIFI is actively engaged with the National Institute of Clinical Excellence (NICE) and anticipates submitting a comprehensive reimbursement dossier by the end of June 2025. Manuela Marrano, SIFI's Executive Director for Regulatory and Market Access, stated, "Receiving Marketing Authorization for AKANTIOR® and its PIM designation marks significant progress in our quest to provide access to this groundbreaking treatment for Acanthamoeba keratitis patients in the UK." This recognition from the MHRA highlights AKANTIOR®'s potential to rectify a considerable unmet medical requirement.

Understanding Acanthamoeba Keratitis

Acanthamoeba keratitis is a rare yet dangerous corneal infection that primarily targets contact lens wearers. Symptoms include intense pain, light sensitivity, and blurred vision, which may progress to severe complications, including potential blindness or loss of the eye. The timely and effective treatment of this infection is crucial, as traditional methods may not always suffice.

AKANTIOR® is formulated in single-dose containers and provides a tailored solution to combat both trophozoite and cyst forms of the Acanthamoeba protozoan, allowing for effective monotherapy.

About SIFI

Founded in 1935, SIFI has emerged as a leading international ophthalmic company dedicated to enhancing lives through innovation in eye care. The company's integrated model spans research, development, manufacturing, and commercialization across pharmaceutical and biomedical sectors. Today, SIFI operates in over 60 countries globally and is expanding its reach through initiatives and collaboration with prominent markets.

SIFI's unwavering commitment to advancing healthcare underscores its proactive approach to addressing unique challenges faced in the ophthalmic sector. For more insights about SIFI and its products, visit www.sifigroup.com.