SIFI Partners with UCSF for Groundbreaking Acanthamoeba Keratitis Study

SIFI Partners with UCSF on Acanthamoeba Keratitis Treatment

In a significant advancement for ophthalmic care, SIFI, a prominent international pharmaceutical company, has announced its collaboration with the University of California, San Francisco (UCSF) in a pioneering scientific trial focused on Acanthamoeba Keratitis (AK). This collaboration aims to improve therapeutic outcomes for AK, a rare but severe parasitic infection of the eye.

The Parasitic Ulcer Treatment Trial (PUTT)

The study, dubbed the Parasitic Ulcer Treatment Trial (PUTT), is led by Dr. Jeremy Keenan, a respected authority in ophthalmology at UCSF. The trial involves multiple sites across the United States as well as Brazil, India, and the United Kingdom, with a goal of enrolling 232 patients. The primary focus of this multicenter, randomized trial is to evaluate whether introducing topical corticosteroids one month after starting an anti-acanthamoebic regimen can improve visual acuity after six months when compared to a placebo treatment.

SIFI is providing its proprietary formulation of polihexanide 0.08%, which has been available in Europe under the brand name Akantior® since October 2024. The first patient in the United States was administered this treatment on March 6, 2025.

Significance of Akantior®

Akantior® represents a significant milestone in the treatment of Acanthamoeba Keratitis. After over 15 years of intensive research and development, SIFI received marketing authorization from the European Commission in August 2024. This approval was aided by the ODAK trial, the most extensive Phase 3 study conducted for AK, which showcased impressive cure rates and established a new level of care for this condition.

The polihexanide formulation is solely granted for use in a clinical trial setting in the U.S. and is yet to be commercially available outside the European Economic Area. Notable clinical trial sites utilizing this drug include renowned institutions like the Francis I. Proctor Foundation at UCSF and Bascom Palmer Eye Institute at the University of Miami.

Expert Insights

Professor Jeremy Keenan expressed enthusiasm for the trial's potential impact, stating, "The PUTT trial is designed to make an evidence-based contribution to an important debate in the management of AK, specifically regarding the efficacy of steroid eyedrops alongside anti-acanthamoebic treatment. Given the serious nature of AK, rapid and effective treatment is essential to prevent irreversible damage."

Fabrizio Chines, CEO of SIFI, emphasized the company's commitment to patient welfare, stating, "Our focus is on enhancing access to our effective treatments globally. As we prepare for the submission of a New Drug Application for Akantior® to the FDA later this year, we are thrilled to support impactful research like the PUTT trial. This landmark collaboration could yield significant benefits not just for AK, but for future research avenues as we explore Polihexanide in contexts like Fungal Keratitis."

Understanding Acanthamoeba Keratitis

Acanthamoeba Keratitis is an ultra-rare and severe corneal infection that can lead to devastating outcomes if not treated promptly. Its incidence in the United States is estimated to be roughly 2,600 new cases each year, primarily affecting young and middle-aged individuals who wear soft contact lenses. Patients often endure excruciating pain, light sensitivity, and a prolonged recovery period, which can severely hinder day-to-day life. Unfortunately, AK may necessitate corneal transplants in severe instances, making effective treatment critical.

The Role of UCSF

The University of California, San Francisco, stands as a well-respected medical institution renowned for its dedication to research, education, and patient care. The UCSF Department of Ophthalmology is leading the charge in investigations aimed at improving treatment outcomes for this kind of rare ocular disease, collaborating with pharmaceutical companies like SIFI to bring new therapies to market.

As the PUTT trial progresses, it promises to contribute vital knowledge, not only enhancing patient care for Acanthamoeba Keratitis but potentially paving the way for developing similar treatments for other rare corneal infections. The clinical community watches with great interest how these findings will influence practice and result in significant advancements in ocular health.

In conclusion, SIFI's partnership with UCSF marks a promising chapter in the treatment of Acanthamoeba Keratitis, encapsulating a collaborative spirit aimed at improving patient outcomes and advancing clinical practices in ophthalmology.