The combination of polihexanide (PHMB) and propamidine is safe and effective for treating the rare sight-threatening eye infection Acanthamoeba keratitis (AK), according to a study recently published in Ophthalmology.

John K.G. Dart, D.M., from Moorfields Eye Hospital in London, and colleagues compared topical PHMB 0.02 percent (0.2 mg/mL) + propamidine 0.1 percent (1 mg/mL) with PHMB 0.08 percent (0.8 mg/mL) + placebo (PHMB 0.08 percent) for AK . The analysis included 127 patients.

The researchers found that the adjusted medical cure rate within 12 months was 86.6 percent (unadjusted, 88.5 percent) for PHMB 0.02 percent + propamidine and 86.7 percent (unadjusted, 84.9 percent) for PHMB 0.08 percent. Results met the noninferiority requirement for PHMB 0.08 percent (adjusted difference, 0.1 percentage point; lower one-sided 95 percent confidence limit, –8.3 percentage points). For both groups, secondary outcomes were similar: median best-corrected visual acuity of 20/20 and an overall treatment failure rate of 13.4 percent, of which 6.3 percent required therapeutic keratoplasty. No serious drug-related adverse events occurred.

"We hope that our new robust findings with polihexanide 0.08 percent will be a game changer for AK treatment, by improving access and the consistency of treatment, addressing currently unmet patient needs," Dart said in a statement.

Several authors disclosed ties to , including SIFI S.p.A., which sponsored and funded the trial.

More information: John K.G. Dart et al, The Orphan Drug for Acanthamoeba Keratitis (ODAK) Trial, Ophthalmology (2023). DOI: 10.1016/j.ophtha.2023.09.031

Journal information: Ophthalmology