#United Kingdom #AKANTIOR #SIFI #Acanthamoeba #Catania

SIFI’s AKANTIOR® Achieves Milestones in the UK

On May 15th, 2025, SIFI, a prominent name in the ophthalmic industry, celebrated a major success with the introduction of AKANTIOR® (Polihexanid 0.08 %) into the UK market. This accomplishment comes after the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted market authorization for the product, reaffirming its Orphan Drug Designation for the treatment of Acanthamoeba keratitis, an infectious disease that can severely affect vision, especially in contact lens wearers.

Significance of the Approval

The approval not only confirms AKANTIOR® as a new therapeutic agent but also recognizes the extensive investment that SIFI has made in developing Polihexanid as a pharmaceutical active ingredient. The development process adhered to stringent good manufacturing practices, ensuring that the efficacy and safety levels demonstrated in clinical trials translate to actual patient care.

In a noteworthy meeting held just days earlier, the MHRA had awarded AKANTIOR® the designation of Promising Innovative Medicine (PIM), validating its potential to significantly address unmet medical needs in the realm of Acanthamoeba keratitis. The MHRA's criteria for PIM designation include serious and life-threatening conditions, substantial gaps in current treatment options, and the prospective significant advantages of the new drug over existing ones.

Transformative Impact on Patient Care

The approval of AKANTIOR® is a landmark achievement as it becomes the first and only authorized treatment in the UK specifically designed to combat Acanthamoeba keratitis. The disease poses a high risk of severe repercussions, including potential blindness if left untreated. Patients suffering from this rare and debilitating condition now have a viable treatment option to alleviate their suffering.

Collaboration for Wider Access

Following its market authorization in the European Economic Area (EEA) in August 2024, the UK approval further broadens AKANTIOR®'s accessibility across Europe. SIFI is currently in discussions with the National Institute for Health and Care Excellence (NICE), with plans to submit a comprehensive dossier for reimbursement by the end of June 2025. Manuela Marrano, Executive Director of Regulatory and Market Access at SIFI, emphasized the importance of this approval in fulfilling the company's mission to provide innovative healthcare solutions to patients ravaged by Acanthamoeba keratitis.

As Marrano stated, "This recognition by the MHRA underscores AKANTIOR®'s potential to fulfill substantial unmet medical needs and confirms its significant patient benefits in managing serious conditions. We are eager to continue our collaboration with NICE to ensure broad access to AKANTIOR® across the UK."

The Unique Features of AKANTIOR®

AKANTIOR® is globally unique, being the only specifically formulated medication for Acanthamoeba keratitis. Its formulation as eye drops utilizing a unique anti-amoebic polymer targets both the trophozoite and cyst forms of the Acanthamoeba protozoan, presenting a tailored solution to managing this challenging infection. Packaged in single-dose containers, AKANTIOR® delivers a steady concentration of 0.08 %, confirming its efficacy as monotherapy.

Understanding Acanthamoeba Keratitis

Acanthamoeba keratitis is a severe, progressive infection of the cornea characterized by intense pain and sensitivity to light. It predominantly affects contact lens users and may necessitate multiple corneal transplantations if left untreated. The absence of effective therapies in the past has made this condition a significant concern in ophthalmology, prompting SIFI's commitment to creating a solution that changes the treatment landscape.

About SIFI

With its roots tracing back to 1935, SIFI is recognized as a leading global ophthalmic company based in Italy. The firm has developed an integrated business model that encompasses research and development, manufacturing, and marketing within the pharmaceutical and biomedical sectors. Dedicated to improving lives through meaningful innovations in eye care, SIFI exports products to over 60 countries, having a direct presence in key European markets, Mexico, and through joint ventures in China and the UAE.

For more information about SIFI and its innovative products, please visit www.sifigroup.com.