Otonomy Inc., a company that makes treatments for the middle and inner ear, has submitted a drug candidate for regulatory approval following encouraging Phase 3 data.

The San Diego-based company is seeking the U.S. Food and Drug Administration’s approval of AuriPro for treatment of middle ear effusion in pediatric patients undergoing tympanostomy tube placement surgery.

If approved within the standard review period, company officials anticipate the treatment will be introduced in the United States during the first half of 2016.

Otonomy is trading on the Nasdaq under the ticker symbol OTIC.