Trial reportThe Annals of otology, rhinology, and laryngology2026
Efficacy and Safety of Finafloxacin Otic Suspension, 0.3% for the Treatment of Acute Otitis Externa: Results from two Phase III Randomized Clinical Studies.
Trial report in The Annals of otology, rhinology, and laryngology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectiveEvaluation of the clinical efficacy and safety of finafloxacin otic suspension in 2 Phase III clinical trials, in patients 6 months or older, reflective of the populations at risk for acute otitis externa (AOE).
methodsTwo identical multicenter, randomized, double-masked, vehicle-controlled prospective Phase III studies in which 1234 patients (≥6 months) with AOE of presumed bacterial origin were randomized at 128 sites in the United States and Canada. Patients received finafloxacin otic suspension or vehicle twice daily for 7 days. The primary efficacy endpoint was the proportion of patients with clinical cure (resolution of tenderness, erythema and edema) on day 11 in the pathogen positive subset of the intention to treat (ITT) population.
resultsPatients of the pathogen positive subset of the ITT population treated with finafloxacin had a clinical cure rate of 70.2% on day 11 (test of cure visit, ToC) compared to 36.6% in the vehicle group (
conclusionsFinafloxacin otic suspension was statistically superior to vehicle in clinical cures, pathogen eradication, and median time to ear pain resolution. It also demonstrated high efficacy against the primary AOE pathogens,
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