(Reuters) - Drug developer Otonomy Inc said on Thursday its drug to treat acute otitis externa (AOE), an infection in the outer ear canal, met the main goal in a late-stage trial.
AOE, also known as swimmer’s ear, is a type of bacterial infection causing inflammation in the external ear canal.
The drug, Otiprio, is approved for use in pediatric patients during tympanostomy tube placement surgery.
Children suffering from middle-ear infection, also known as otitis media with effusion (OME), undergo a tympanostomy tube placement surgery to drain out accumulated fluid and simplify the administration of antibiotics.
The company said it would submit a supplemental marketing application with the U.S. Food and Drug Administration in the first half of 2017.
Otiprio, which was approved in late 2015, generated sales of $300,000 in the third quarter of 2016.
There are nearly 4 million cases of AOE each year in the United States, according to the company.
Reporting by Divya Grover in Bengaluru; Editing by Shounak Dasgupta