, May 8, 2014
/PRNewswire/ -- Otonomy, Inc., a biopharmaceutical company developing and commercializing innovative therapeutics for diseases and disorders of the inner and middle ear, today announced enrollment has been completed in its pivotal studies of AuriPro (previously known as OTO-201) for the treatment of pediatric patients with bilateral middle ear effusion requiring tympanostomy tube placement.
The two identical, prospective, randomized, double-blind, sham-controlled Phase 3 studies enrolled a combined total of 532 subjects, ages 6 months to 17 years old, across approximately 50 trial sites in the United States and Canada. The primary endpoint of the studies is the effectiveness of AuriPro as measured through day 15 by the cumulative proportion of study treatment failures, which is defined as the presence of otorrhea (drainage) or use of antibiotic rescue medication.
"Completing enrollment on schedule puts us one step closer to commercializing our first product and offering an important treatment for pediatric patients undergoing ear tube placement surgery," said David A. Weber, Ph.D., president and CEO of Otonomy. "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."
AuriPro is a proprietary, sustained-exposure formulation of the antibiotic ciprofloxacin that has been designed for administration by ear, nose and throat (ENT) specialists to treat a broad range of otic conditions including recurrent and persistent otitis media. Nonclinical studies have demonstrated that a single administration of AuriPro provides sustained ciprofloxacin drug concentrations in the middle ear that exceed levels observed with twice-daily dosing of antibiotic ear drops for seven days. The lead indication for AuriPro is intra-operative treatment of middle ear effusion (fluid) in pediatric patients requiring tympanostomy tube placement surgery. The product candidate successfully completed a Phase 1b trial that demonstrated a statistically significant reduction of treatment failure of more than 60 percent relative to the placebo/sham group (p<0.05) and the therapy appeared to be well tolerated.
About Tympanostomy Tube Placement Surgery
Approximately one million tympanostomy tube placement procedures are conducted each year in the United States for the treatment of persistent or recurrent otitis media (infection and/or inflammation of the middle ear) with three-quarters of the surgeries performed in children age 5 and under. The vast majority of patients receiving tubes have middle ear effusion at the time of surgery which significantly increases their risk of post-operative complications including otorrhea (drainage) and tube occlusion. A number of physician-sponsored clinical studies have demonstrated that administration of topical antibiotics during and immediately following tube placement surgery significantly reduces this risk. However, no antibiotic product has been approved by the FDA for this use and current treatment relies on parent compliance which can be challenging in a young child for the full course of the multi-day dosing regimen.
Otonomy is a biopharmaceutical company developing and commercializing innovative therapeutics for diseases and disorders of the ear. Otonomy's proprietary technology provides sustained exposure of drugs to the middle and inner ear following a single intratympanic (IT) injection. Otonomy has three product candidates in development. AuriPro is an antibiotic that is in Phase 3 clinical trials in pediatric patients with middle ear effusion at the time of tympanostomy tube placement surgery. OTO-104 is a steroid that is in the first of two pivotal clinical studies for the treatment of patients with Ménière's disease. OTO-311 is an NMDA receptor antagonist in development as a treatment for tinnitus. For more information please visit: www.otonomy.com.
Robert H. Uhl
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SOURCE Otonomy, Inc.