SAN DIEGO, July 8, 2014 /PRNewswire/ -- Otonomy, Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced positive results from two identical Phase 3 trials of AuriPro™ in a combined total of 532 pediatric patients with bilateral middle ear effusion requiring tympanostomy tube placement. In both trials, AuriPro achieved the primary efficacy endpoint with statistical significance (p<0.001), showed statistically significant improvements in secondary clinical endpoints and was well tolerated.
"We are pleased with these results and plan to continue to progress forward to filing for regulatory approval of AuriPro in the United States," said David A. Weber, Ph.D., president and chief executive officer of Otonomy.
The prospective, randomized, double-blind, sham-controlled Phase 3 studies enrolled subjects, ages six months to 17 years old, across approximately 60 trial sites in the United States and Canada. The primary endpoint of the studies was the effectiveness of AuriPro as measured by the cumulative proportion of study treatment failures through day 15, which is defined as the presence of otorrhea (drainage) or use of antibiotic rescue medication. Otonomy plans to present the full results at an appropriate medical meeting in the future.
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 has completed two Phase 3 clinical trials.
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. Since the tympanostomy tube by itself is frequently insufficient to treat the middle ear effusion, antibiotic ear drops are routinely used during and following the procedure. 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-dose, multi-day regimen.
Otonomy is a clinical-stage biopharmaceutical company focused on the development and commercialization of 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 has completed 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.
SOURCE Otonomy, Inc.