SIFI S.p.A., an Italian pharmaceutical company specialising in ophthalmology, announced on Tuesday that it has entered into a scientific collaboration with the University of California, San Francisco (UCSF), aimed at improving the management of Acanthamoeba Keratitis (AK), an ultra-rare, acute, severe parasitic corneal infection caused by acanthamoeba, a free-living amoeba.

The Parasitic Ulcer Treatment Trial (PUTT), an investigator-initiated study, is headed by Dr Jeremy Keenan, professor of Ophthalmology at UCSF, and is being conducted at multiple sites across the United States of America, Brazil, India and the United Kingdom, with the aim of enrolling 232 patients.

The trial's primary objective is to assess if patients who start topical corticosteroids one month after beginning an anti-acanthamoebic regimen will have better visual acuity at six months compared to patients given a placebo eyedrop.

SIFI received Marketing Authorisation 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.

The product is not yet commercially available outside the European Economic Area. It will be accessible for AK patients being enrolled in the PUTT.