Alcon's Xtoro For "Swimmer's Ear" Gets FDA Green Light

Novartis company, Alcon Laboratories, has received approval from the U.S. Food and Drug Administration (FDA) for its drug Xtoro (finafloxacin otic suspension) as treatment for acute otitis externa, also known as “swimmer’s ear.”

Xtoro is a member of the fluoroquinolone antimicrobial drug class that targets the bacteria Pseudomonas aeruginosa and Staphylococcus aureus, which causes acute otitis externa.

Acute otitis externa is an infection of the outer ear and ear canal usually caused by bacteria in the ear canal. These can be picked up during swimming and other underwater activities that can introduce water into the ear canal where bacteria can flourish. Symptoms include pain, redness of the ear, swelling, tenderness, and ear discharge.

The FDA approval is based on positive safety and efficacy data from two randomized clinical trials involving patients between 6 months old and 85 years old who received either Xtoro or a vehicle containing a solution without fluoroquinolone. The primary endpoint of the trials was resolution of ear tenderness, redness, and swelling. Xtoro achieved clinical cure for 70 percent of patients whose acute otitis externa was caused by either bacteria versus 37 percent of those who received the vehicle. The drug was also shown to be superior to the vehicle for eliminating bacteria from the ear, as well as for relieving ear pain faster.

“The availability of multiple treatment options allows physicians and patients to find the treatment to meet their needs,” said Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Alcon, which is Novartis’ second largest division, also reported the approval of the European Commission for its eye drop suspension Simbrinza as treatment for glaucoma in the EU earlier this year. Novartis also established a license agreement with Google for its ‘smart lens’ technology through its subsidiary Alcon Labs in July this year.