Otonomy wins FDA approval for a first-of-its-kind ear treatment

Otonomy CEO David Weber

Otonomy ($OTIC) won FDA approval for its first product, a one-time ear treatment designed to reduce complications after tube placement, and the small biotech is gearing up to launch the product on its own.

The drug, Otiprio, is a sustained-release formulation of the antibiotic ciprofloxacin, now cleared for use in children who have ear infections that require tube placement. Such procedures are performed about 1 million times each year in the U.S., according to Otonomy, and 85% of recipients are children. Physicians implant tubes to ease the administration of infection-fighting antibiotics, and Otonomy's drug is meant to significantly reduce the rate of complications in the process, sparing parents from constantly administering ear drops.

Otonomy is now planning to get Otiprio on the market in the first quarter of next year, recruiting a 40-person sales force to market its treatment. The company has said it plans to look for a partner to commercialize the drug overseas.

The potential of Otiprio, formerly AuriPro, was a major driver in Otonomy's $100 million IPO, closed last year. The company is advancing a pipeline of treatments for ear disorders, and CEO David Weber has said the global market for Otonomy's products measures above $1 billion year.

The San Diego company hit a snag earlier this year when OTO-104, its second candidate, missed its main goal in a Phase IIb trial in an inner ear disorder called Ménière's disease. But Otonomy, citing "trends" toward clinical efficacy, has moved the treatment into Phase III anyway, launching a late-stage study in November.

Otonomy is also running a Phase I trial on OTO-311, an NMDA agonist designed to treat tinnitus.

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