Otonomy heads to the FDA after its ear treatment clears Phase III

Otonomy CEO David Weber

Privately held Otonomy is touting positive late-stage results for its investigational ear treatment, gearing up for an FDA application just months after raising $49 million in venture cash.

AuriPro, formerly OTO-201, is a sustained-release formulation of the antibiotic ciprofloxacin designed to reduce postoperative complications in pediatric patients undergoing tube-placement surgery. In two Phase III trials, the treatment did just that, Otonomy said, meeting its primary endpoint of 15-day freedom from ear drainage in patients aged 6 months to 17 years old.

Now the San Diego biotech is preparing for a regulatory filing, CEO David Weber said, and the company is planning to launch AuriPro in the U.S. on its own, keeping an eye out for partners who can help move the product overseas.

About 1 million such tube placements are conducted in the U.S. each year, Otonomy figures, and the majority of patients require inconvenient, twice-daily administrations of antibiotic ear drops for 7 days. AuriPro is designed to provide a single-dose solution to procedural after effects, and the company believes it can shoulder its way onto the market with a specialist sales force targeting ear, nose and throat specialists.

Otonomy has $49 million in fresh financing to get it there, in April closing a round that brought in new investors including Jennison Associates, Perceptive Advisors and Federated Kaufmann Funds, alongside repeat backers like OrbiMed, Novo, TPG Biotech and Domain Associates.

Beyond AuriPro's launch, that funding will help speed along OTO-104, a Phase III steroid treatment for an inner ear disorder called Ménière's disease that disrupts hearing and balance. Otonomy also has a preclinical tinnitus drug that will soon make its way into clinical trials thanks to the new funding, the company said.

The company has raised about $143 million since its foundation in 2008, and Otonomy's investors include Avalon Ventures, RiverVest Venture Partners and Aperture Venture Partners.

- read the release