SIFI provides updates on the UK and US regulatory pathways for AKANTIOR® in the treatment of acanthamoeba keratitis

• Filing of ASMF and MAA sets the stage for a potential approval in Q2 2025 in the UK
• Type C meeting feedback confirms pre-clinical and clinical data are adequate for an NDA submission and potential approval of AKANTIOR® in the US

CATANIA, Italy, Dec. 16, 2024 /PRNewswire/ -- SIFI, a leading international ophthalmic company, announced the accomplishment of a key milestone in the pursuit of regulatory approvals in the United Kingdom ("UK") and regulatory progress for filing in the United States of America ("USA") for AKANTIOR® in the treatment of Acanthamoeba Keratitis ("AK").

In the UK, SIFI submitted a Marketing Authorization Application ("MAA") for AKANTIOR® and an Active Substance Master File ("ASMF") for its proprietary GMP-grade polihexanide to the Medicines and Healthcare products Regulatory Agency ("MHRA"). This submission follows the European Commission's authorization for AKANTIOR as an orphan medicinal product and the confirmation of eligibility for the International Recognition Procedure from the MHRA. SIFI also applied for an Orphan Drug Designation ("ODD"), which will be evaluated during the regulatory procedure, and for a Promising Innovative Medicine Designation.

In the USA, SIFI held a Type C meeting with the Food and Drug Administration ("FDA"), according to its regulatory strategy targeting a New Drug Application ("NDA") in the second half of 2025. The outcome of the meeting supports the company's position that its existing data package, both clinical and non-clinical, will be sufficient for the submission of a NDA and the potential approval of AKANTIOR® in the US, currently anticipated in 2026. The FDA granted the ODD for the US patent in 2025 and of the New Chemical Entity status for polihexanide upon approval.

"Following the successful pivotal trial, approval and the commercial launch in the European Union, the regulatory submission in the UK and the pre-submission meeting in the USA mark further important milestones in our commitment to making AKANTIOR®, the first and only approved treatment for AK, available to patients globally." said Fabrizio Chines, Chairman and CEO of SIFI. "As the proportion of population wearing contact lenses in the USA is four times higher than in the European Union, we believe our innovative medicine can make an even higher impact on the medical and social needs of patients suffering from this devastating disease."

ABOUT AKANTIOR^®: AKANTIOR (polihexanide 0.08%) is the first and only approved drug for the treatment of AK in the world. It is an anti-amoebic polymer that acts on both the trophozoites and cysts of the protozoan acanthamoeba. It is formulated at a 0.8mg/ml (0.08%) concentration which makes it possible to administer as monotherapy eye drops in single-dose containers.

ABOUT AK: AK is an ultra-rare, acute, severe parasitic corneal infection caused by acanthamoeba, a free-living amoeba, although incidence of AK has been rapidly growing in recent years. AK is an ocular emergency and requires urgent treatment to save the eye. It can lead to poor vision, potential blindness, or even eye loss and often requires single or multiple corneal transplants. It affects people of all ages, most of whom are young or middle-aged soft contact lens wearers. Patients report unbearable pain and extreme light sensitivity and can rarely work or lead normal lives until symptoms resolve. 

ABOUT SIFI: SIFI is a leading international ophthalmic company, headquartered in Italy, featuring an integrated business model, from research & development to manufacturing and commercialization both in pharmaceutical and biomedical sectors. Since our foundation in 1935, our mission is to improve people's lives through meaningful innovation in eye care. SIFI 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. More information available at www.sifigroup.com

SOURCE SIFI S.p.A.