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Introduction <p>Topical polyhexamethylene biguanide (PHMB) 0.08% (AKANTIOR<sup>®</sup>, SIFI Italy) is the only licensed medicinal product for the treatment of <i>Acanthamoeba</i> keratitis (AK), demonstrating an 84.9% cure rate in a pivotal clinical trial. This study aimed to evaluate its effectiveness and safety in a routine clinical practice.</p> Methods <p>We retrospectively reviewed patient charts from ten Italian centers for the treatment of AK with PHMB 0.08% monotherapy. The treatment protocol followed that used in the pivotal trial. The primary outcome was medical cure, defined as a healed epithelium without inflammation and treatment for at least four&#xa0;weeks. Treatment failure was defined as the need for surgery or the use of alternative or additional anti-amoebic treatments (AAT). Secondary outcomes included best-corrected visual acuity (BCVA), time to cure, pain, and corneal scarring.</p> Results <p>Thirty-nine patients (M/F = 14/25) were evaluated. AK was confirmed by confocal microscopy ± polymerase chain reaction or culture in all cases. Sixteen (41%) had stage 3 AK. Thirty-five (89.7%; 95% confidence intervals 80.2–99.3) achieved medical cure. Four failures occurred: three required corneal surgery and one additional AAT. At the end of treatment, mean (SD) LogMAR BCVA was 0.7 (0.8); the median time to cure was 95&#xa0;days (Q1–Q3: 63–140&#xa0;days). Two patients (5.6%) reported residual pain, and 27 (73.0%) had corneal scarring. Four serious adverse events (three hypopyon, one corneal perforation) were reported and considered unlikely to be treatment-related.</p> Conclusions <p>AKANTIOR cured approximately 90% of patients with AK, indicating that the efficacy observed in the clinical trial can be replicated in clinical practice.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT06641882.</p>

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A Multicenter, Real-World Experience with Polyhexamethylene Biguanide (PHMB) 0.08% Monotherapy for Treating Acanthamoeba Keratitis: A Retrospective Review of 39 Cases

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月15日

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  • Karl Anders Knutsson,
  • Antonio Di Zazzo,
  • Emilio Pedrotti,
  • Paolo Rama,
  • Vito Romano,
  • Anna Maria Roszkowska,
  • Giacinto Triolo,
  • Francesco Aiello,
  • Stefano De Angelis,
  • Rita Mencucci,
  • Pasquale Aragona,
  • Federica Birattari,
  • Erika Bonacci,
  • Matilde Buzzi,
  • Marco Coassin,
  • Adriano Fasolo,
  • Mariangela Gari,
  • Pia Leon,
  • Carlo Nucci,
  • Giorgio Paganoni,
  • Matteo Pederzolli,
  • Fabiana Secchi,
  • Sabrina Vaccaro,
  • Vincenzo Papa,
  • Antonella Franch

摘要

Introduction

Topical polyhexamethylene biguanide (PHMB) 0.08% (AKANTIOR®, SIFI Italy) is the only licensed medicinal product for the treatment of Acanthamoeba keratitis (AK), demonstrating an 84.9% cure rate in a pivotal clinical trial. This study aimed to evaluate its effectiveness and safety in a routine clinical practice.

Methods

We retrospectively reviewed patient charts from ten Italian centers for the treatment of AK with PHMB 0.08% monotherapy. The treatment protocol followed that used in the pivotal trial. The primary outcome was medical cure, defined as a healed epithelium without inflammation and treatment for at least four weeks. Treatment failure was defined as the need for surgery or the use of alternative or additional anti-amoebic treatments (AAT). Secondary outcomes included best-corrected visual acuity (BCVA), time to cure, pain, and corneal scarring.

Results

Thirty-nine patients (M/F = 14/25) were evaluated. AK was confirmed by confocal microscopy ± polymerase chain reaction or culture in all cases. Sixteen (41%) had stage 3 AK. Thirty-five (89.7%; 95% confidence intervals 80.2–99.3) achieved medical cure. Four failures occurred: three required corneal surgery and one additional AAT. At the end of treatment, mean (SD) LogMAR BCVA was 0.7 (0.8); the median time to cure was 95 days (Q1–Q3: 63–140 days). Two patients (5.6%) reported residual pain, and 27 (73.0%) had corneal scarring. Four serious adverse events (three hypopyon, one corneal perforation) were reported and considered unlikely to be treatment-related.

Conclusions

AKANTIOR cured approximately 90% of patients with AK, indicating that the efficacy observed in the clinical trial can be replicated in clinical practice.

Trial Registration

ClinicalTrials.gov identifier, NCT06641882.