Otonomy Inc (Nasdaq: OTIC), San Diego, announced today that the US Food and Drug Administration (FDA) has approved OTIPRIO™ (ciprofloxacin otic suspension) for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. OTIPRIO is a single-dose, physician-administered antibacterial, and is reportedly the first product approved by the FDA for this indication.
“The approval of OTIPRIO, our first product, is a landmark moment in the history of Otonomy, and provides important validation for our proprietary drug delivery technology that combines a thermosensitive gel with drug microparticles to enable single dose treatment by a physician,” said David A. Weber, PhD, president and CEO of Otonomy. “We have an experienced commercialization team in place, are building out our 40-person sales force, and look forward to launching OTIPRIO in the first quarter of 2016.”
“As someone who routinely sees young children suffering with persistent ear infections and performs hundreds of tube surgeries each year, I welcome the approval of OTIPRIO as the first FDA approved product for this indication,” said Eric Mair, MD, of Charlotte Eye Ear Nose and Throat Associates. “Being able to administer a single dose of OTIPRIO during the procedure gives me the assurance of antibiotic dosing which the Phase 3 trials demonstrate reduces the rate of treatment failure following surgery.”
Otonomy secured $45.9 million in funding in 2013, and the San Diego-based clinical stage biopharmaceutical company continues to pursue new therapeutics for diseases and disorders of the inner and middle ear. The company also has in its product development pipeline an intratympanic (IT) injection for patients with Ménière’s disease and OTO-104 for the treatment of Ménière’s Disease.
Several companies are in hot pursuit of pharmaceutical treatments for hearing loss, hearing loss prevention, and tinnitus remediation. Recently, Third Rock Ventures LLC, a healthcare venture firm, announced the launch of Decibel Therapeutics, with $52 million in Series A financing by Third Rock and SR One, the corporate venture capital arm of GlaxoSmithKline, to discover new medicines that protect, repair, and restore hearing. For more on these ventures, see New Drugs for Hearing Loss Expected in 5 Years.