Results of phase III trial of Otiprio (ciprofloxacin otic suspension) in tympanostomy published in JAMA Otolaryngology- Otonomy

Otonomy has announced the publication of the positive results of the Phase III clinical trials of Otiprio (ciprofloxacin otic suspension) in JAMA Otolaryngology – Head & Neck Surgery. The trial results are from two identically designed, prospective, double-blind, sham-controlled, multicenter Phase III randomized clinical trials of Otiprio in a total of 532 pediatric patients undergoing tympanostomy tube placement (TTP).

The two Phase III trials enrolled a total of 532 patients at approximately 50 centers in the U.S. and Canada. Pediatric patients with bilateral middle ear effusion on the day of surgery were randomized to receive TTP alone or TTP with a single intraoperative administration of Otiprio. The primary efficacy endpoint was treatment failure defined as the presence of otorrhea, use of otic or systemic antibiotics, loss to follow-up or missed visits through Day 15. The cumulative proportion of treatment failures was 24.6% in Trial 1 and 21.3% in Trial 2 in the Otiprio treatment groups, compared to 44.8% in Trial 1 and 45.5% in Trial 2 in the TTP alone groups. The most frequently reported adverse events in both trials were nasopharyngitis, irritability, and rhinorrhea. No drug-related serious adverse events were seen. No evidence of increased tube occlusion and no negative effect on results of audiometry, tympanometry, or otoscopy were noted with Otiprio administration.