FDA Approves Alcon Research’s Xtoro for Swimmer’s Ear

The FDA has cleared Alcon Research’s eardrop Xtoro for acute otitis externa infection, marking the agency’s first new approval of a flouroquinolone antibiotic.

Approval of Xtoro (finafloxacin otic) for the condition known as swimmer’s ear followed two studies of 1,234 adults and children that found 70 percent of subjects taking Xtoro were cured, compared with 37 percent given a placebo. Xtoro also proved better at clearing bacteria and reducing pain and swelling.

Acute otitis externa is a bacterial infection of the outer ear and ear canal generally caused by either Pseudomonas aeruginosa or Staphylococcus aureus.

While swimmer’s ear is not generally considered dangerous, both P. aeruginosa and S. aureus are on an agency list of qualified pathogens needing new antibiotic treatment options. — Lena Freund