Otonomy, Inc. OTIC announced that its ear infection drug, Otiprio, was approved in the U.S. for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement (TTP).
Otiprio is expected to be available in the U.S. in the first quarter of 2016.
According to information provided by the company, it is estimated that approximately 1 million TTP procedures are performed each year in the U.S., of which 85% are in pediatric patients who typically have middle ear effusion and receive tubes in both ears (bilateral).
Moreover, Otiprio is being evaluated in a phase II study in patients with acute otitis externa, also known as swimmer's ear.
In addition, Otonomy expects to initiate a second phase II study on Otiprio for the treatment of pediatric patients with acute otitis media with tympanostomy tubes in the first quarter of 2016.
We note that Otiprio is the first product approved by the FDA for the abovemention indication.
Otonomy has also updated its financial guidance for 2015. The company expects operating expenses to be below the previous guidance of $65–$60 million. Cash, cash equivalents and short-term investments are expected in the range of $180–$185 million from the previous guidance of $165–$170 million. However, 2016 guidance for operating expenses was maintained at the $90–$95 million range.
Otonomy currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Achillion Pharmaceuticals, Inc. ACHN, Anika Therapeutics Inc. ANIK and Corcept Therapeutics Incorporated CORT, each sporting a Zacks Rank #1 (Strong Buy).
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