FDA approves Novartis/Alcon's Xtoro for swimmer's ear
- An important new treatment option has been approved for acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus—a condition known as swimmer's ear. Xtoro (finafloxacin otic suspension) is an easy-to-use eardrop from Alcon (a subsidiary of Novartis).
- The clinical trials underscoring the approval of Xtoro included 1,234 participants between the ages of 6 and 85.
- 70% of Xtoro-treated patients achieved clinical cure.
Many pediatricians encounter otitis media as a common childhood condition; however, otitis media externa affects people of all ages.
Acute otitis media externa is an infection of the outer ear and ear canal associated with the bacteria that grows in moist environments—often a condition caused by underwater activities.
The clinical database for Xtoro includes both safety and efficacy data in a population up to age 85. And because of its easy-to-use ear-drop application, it will most likely become a go-to treatment option for physicians treating this condition.