SIFI Receives European Commission Approval for AKANTIOR®

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AKANTIOR® (polihexanide) is the first and only approved drug for the treatment of acanthamoeba keratitis

CATANIA, Italy, Aug. 26, 2024 /PRNewswire/ -- SIFI, a leading international ophthalmic company, today announced the European Commission has approved AKANTIOR® (polihexanide) for the treatment of acanthamoeba keratitis (AK) in adults and children from 12 years of age, confirming the orphan status of the product. AKANTIOR is the first and only approved therapy for people suffering from AK in Europe. 

AK is an ultra-rare, severe, progressive and sight threatening corneal infection characterized by intense pain and photophobia. AK is caused by a free-living amoeba, acanthamoeba, and primarily affects contact lens wearers.

"Today's approval represents an important step towards delivering a new global standard of care for patients with AK and builds on 15 years of research and development," said Fabrizio Chines, Chairman and CEO of SIFI. "For the first time in Europe AK patients have an approved therapy, marking a new era in the treatment of this disease, which may lead to blindness. AKANTIOR is the first and only approved medicine for AK, and our team is committed to developing polihexanide in other corneal infectious diseases, such as fungal keratitis, where we obtained orphan drug designation from the EMA and the FDA."

"AKANTIOR, when used as monotherapy with the trial's treatment protocol, achieves medical cure rates of over 86% and is set to become the standard of care for this severe and debilitating disease," stated Professor John Dart, of Moorfields Eye Hospital and the UCL Institute of Ophthalmology, who was Principal Investigator of the Phase III ODAK trial. "After 15 years of research and effort development by SIFI, culminating in the pivotal Phase III clinical trial, polihexanide 0.08% has now been approved by the European Medicines Agency and European Commission as the first licensed treatment for acanthamoeba keratitis. This breakthrough offers significant improvement over current treatment options and has the potential to prevent blindness and save eyes. As the only approved therapy, it has been recommended for use with the detailed treatment delivery protocol used in the Phase 3 trial, which eliminates the need for the variable individualized treatment delivery currently used for patients, providing an effective standardized approach that can be followed by any clinician and which has been shown to be effective, not only in the Trial, but also in the current compassionate use program outside the more stringent Trial setting."

"With the approval of AKANTIOR, AK patients (also known as AK Warriors) are now one step closer to having access to the best possible treatment in the EU. This milestone represents a significant step towards providing fair healthcare to all AK Warriors, giving them hope for a brighter future," commented Juliette Vila Sinclair Spence, a rare disease patient advocate and the Chairwoman and Founder of AK Eye Foundation – the first global foundation dedicated exclusively to this condition.

In Europe, SIFI plans to initiate its first commercial launch in Germany during the last quarter this year, followed by additional markets based on local regulatory, healthcare technology assessment and reimbursement process timelines, including France, Italy, Romania, Spain, United Kingdom and Turkey addressing a total population of 430 million, and by Avanzanite, its commercial partner, in other European Countries addressing an additional population of 180 million. Based on scientific publications, the incidence of acanthamoeba keratitis is estimated at 1 to 4 patients per million inhabitants.

ABOUT AKANTIOR®: AKANTIOR (polihexanide 0.08%) is the first approved drug for the treatment of acanthamoeba keratitis 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. The European Commission confirmed the orphan status of the product. The FDA granted SIFI Orphan Drug Designation for the treatment of acanthamoeba keratitis.

ABOUT Acanthamoeba Keratitis (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 and 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 40 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.