SIFI announces collaboration with the University of California, San Francisco on Acanthamoeba Keratitis

• The University of California San Francisco is coordinating the Parasitic Ulcer Treatment Trial, a study aimed at understanding the role of topical corticosteroids after initiation of anti-amoebic therapy
• SIFI is supporting the trial with its proprietary polihexanide 0.08%, commercially available in Europe since October 2024 under the brand name Akantior®
• The first US patient was dosed on March 6, 2025 with SIFI's polihexanide 0.08%

CATANIA, Italy, March 18, 2025 /PRNewswire/ -- SIFI, a leading international pharmaceutical company specializing in ophthalmology, is pleased to announce a scientific collaboration with the University of California, San Francisco ("UCSF") aimed at improving the management of Acanthamoeba Keratitis ("AK").

The Parasitic Ulcer Treatment Trial ("PUTT") is an investigator-initiated study led by Dr. Jeremy Keenan, Professor of Ophthalmology at UCSF, and performed at multiple sites across the United States of America, Brazil, India and the United Kingdom, with the objective of enrolling 232 patients. The primary objective of this multicenter, randomized controlled trial is to determine whether patients who start topical corticosteroids 1 month after beginning an anti-acanthamoebic regimen will have better visual acuity at 6 months compared to patients given a placebo eyedrop.

SIFI received a Marketing Authorization from the European Commission for Akantior® (polihexanide 0.08%) in August 2024 after over 15 years of research and development. Its approval was supported by the ODAK trial, the largest Phase 3 study ever conducted for AK, which demonstrated high cure rates and set a new standard of care. SIFI holds international patents on Akantior®, including the US application 2023/0263824.

Polihexanide 0.08%, not yet commercially available outside the European Economic Area, will be accessible for AK patients being enrolled in the PUTT at the following sites:

• Francis I. Proctor Foundation at the University of California, San Francisco (USA)
• Eye and Ear Infirmary at the University of Illinois at Chicago (USA)
• Jules Stein Eye Institute at University of California, Los Angeles (USA)
• Bascom Palmer Eye Institute at the University of Miami (USA)
• Wilmer Eye Institute at Johns Hopkins University (USA)
• Casey Eye Institute at Oregon Health Science University (USA)
• University of Pennsylvania (Philadelphia, Pennsylvania, USA)
• University of Iowa (USA)
• Columbia University (USA)
• University of Florida (USA)
• São Paulo Hospital at the Federal University of Sao Paulo (Brazil)
• Moorfields Eye Hospital (England)
• Aravind Eye Care System (India)

On March 6^th, the first US patient was dosed at UCSF with SIFI's Polihexanide 0.08% under the study protocol.

Prof. Jeremy Keenan, Principal Investigator at UCSF, commented:

"The PUTT trial is designed to make an evidence-based contribution to an important debate in the management of AK: the use of adjunctive corticosteroid eyedrops alongside an effective antiamoebic treatment. AK is a rare but very severe ocular infection that can potentially lead to blindness and requires urgent treatment.  Using a high-concentration, more potent anti-amoebic eyedrop produced in accordance with pharmaceuticals' good manufacturing practices, instead of the lower concentrations typically ordered from compounding pharmacies, will allow us to more cleanly study the anti-inflammatory effect of adjunctive corticosteroid eyedrops, reducing variability arising from the use of compounded formulations across multiple clinical sites."

Fabrizio Chines, CEO of SIFI, added:

"At SIFI, patients always come first. We strive to improve access to our most effective treatment for AK worldwide. Whilst we continue our engagement with the FDA to submit a New Drug Application for Akantior® later this year, we are delighted to support Prof. Keenan and the other investigators of the PUTT trial with our proprietary GMP-grade Polihexanide 0.08%. It is great to see that the first patient in the US has received our drug, after many years of R&D investments. I also hope this is the beginning of fruitful collaborations in rare corneal infections, as we advance the clinical development of Polihexanide in Fungal Keratitis, following the Orphan Drug Designations received in the USA and Europe."

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. Incidence in the USA has been estimated at 2,600 new cases per year. 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 UCSF: The University of California, San Francisco (UCSF) is a world-renowned medical institution dedicated to research, education, and patient care. The UCSF Department of Ophthalmology is at the forefront of vision research and clinical innovation, working to improve treatment outcomes for rare and severe eye diseases.

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 

The information stated above was prepared by SIFI and reflects solely the opinion of SIFI. Nothing in this statement shall be construed to imply any support or endorsement of SIFI or any of its products by the Regents of the University of California, its officers, agents and employees. Prof. Keenan will not receive any compensation from SIFI on this research program.

SOURCE SIFI S.p.A.