Phase 3 Trial Evaluating Polihexanide for AK Reaches Full Enrollment

While there are some treatment options for Acanthamoeba keratitis (AK), they often vary from country to country, or even doctor to doctor. The variability could worsen patient outcomes. As a result, a more effective and accessible treatment option is necessary. Currently, Italian ophthalmic company SIFI is working to meet that need with their polihexanide 0.08% therapy. On November 19, SIFI announced that its Phase 3 trial to evaluate this treatment for AK reached full enrollment.


The Phase 3 clinical trial will analyze the safety, efficacy, and tolerability of polihexanide 0.08% in patients with AK. Altogether, 135 patients enrolled in the trial. Currently, other unlicensed treatments use polihexanide 0.02% in conjunction with propamidine 0.1%. However, if effective, polihexanide 0.08% could become the first approved and licensed AK treatment. This therapy also received Orphan Drug designation in both the U.S. and EU. This investigational disinfectant addresses Acanthamoeba trophozoites and cysts. Unlike other treatments, polihexanide 0.08% is administered as a mono therapy. Overall, SIFI hopes to announce topline data in the latter half of 2021.

Acanthamoeba Keratitis (AK)

Acanthamoeba keratitis (AK) is an extreme corneal infection caused by Acanthamoeba. This species of bacteria is usually found in water sources such as stagnant ponds, lakes, tap water, HVAC systems, hot tubs, and even saline solution for contact lenses. Outside of ocular impact, Acanthamoeba infection can also lead to headaches, confusion, nausea and vomiting, seizures, and muscle weakness. Learn more about Acanthamoeba infection.

When Acanthamoeba infects the cornea, it causes AK. This condition is extremely rare. An estimated 1-4 out of every 1M people develop AK each year. However, according to the CDC:

In the United States, an estimated 85% of AK cases occur in contact lens wearers.

Because of its presentation, AK can be difficult to diagnose. However, it is often disabling and prevents patients from leading their daily lives. As a result, discovering a new treatment option is extremely important. Symptoms include:

  • Light sensitivity
  • Eye pain
  • Vision loss
  • Blurry vision
  • Excessive tearing or watery eyes
  • Feeling as though something is stuck in the eye
  • Eye irritation
  • Infection that fails to clear up even with treatment
Jessica Lynn

Jessica Lynn

Jessica Lynn has an educational background in writing and marketing. She firmly believes in the power of writing in amplifying voices, and looks forward to doing so for the rare disease community.

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