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news.US-based biopharmaceutical firm Otonomy has completed enrollment in its pivotal trials of AuriPro (previously known as OTO-201) to treat pediatric patients with bilateral middle ear effusion requiring tympanostomy tube placement.
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AuriPro is a proprietary, sustained-exposure formulation of the antibiotic ciprofloxacin that has been designed for administration by ear, nose and throat (ENT) specialists for the treatment of a broad range of otic conditions including recurrent and persistent otitis media.
A total of 532 subjects, ages six months to 17 years old, across about 50 trial sites in the US and Canada are enrolled in the two identical, prospective, randomized, double-blind, sham-controlled Phase III studies.
Primary endpoint is the effectiveness of AuriPro as measured through day 15 by the cumulative proportion of trial treatment failures, which is defined as the presence of otorrhea (drainage) or use of antibiotic rescue medication.
Otonomy president and CEO David Weber said completing enrollment on schedule puts the company one step closer to commercializing its first product and offering an important treatment for pediatric patients undergoing ear tube placement surgery.
"We would like to thank the many patients, parents, and investigators who participated in the Phase 3 clinical trials, and look forward to having top-line data to announce in the third quarter," Weber said.
Otonomy is focused in developing and commercializing new therapeutics for diseases and disorders of the inner and middle ear.