The Food and Drug Administration (FDA) has approved Xtoro (finafloxacin otic suspension; Alcon) for the treatment of acute otitis externa (also known as swimmer’s ear) caused by Pseudomonas aeruginosa and Staphylococcus aureus.

The safety and efficacy of Xtoro were established in two clinical trials in which patients aged 6 months to 85 years (n=1,234) were randomized to receive Xtoro or its vehicle. Clinical cure was defined as complete resolution of ear tenderness, redness, and swelling. Of the 560 patients who had acute otitis externa caused by P. aeruginosa or S. aureus, 70% of the Xtoro group achieved clinical cure vs. 37% of the vehicle group. Treatment with Xtoro also showed superiority over the vehicle in clearing the bacteria as assessed by ear culture and earlier ear pain relief.

RELATED: Ear Infections Patient Information Fact Sheet

Xtoro otic suspension is the newest fluoroquinolone antibiotic to be approved by the FDA.

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