ABSTRACT
PURPOSE: Otorrhea frequently follows tympanostomy tube (TT) placement. We evaluated otorrhea following single 6mg OTO-201 (OTIPRIO®, ciprofloxacin otic suspension 6%) intraoperative injection into each middle ear in a variety of effusion types and concurrent procedures in children undergoing TT placement. SECONDARY OBJECTIVE: Efficacy based on Medicaid status and safety. BASIC PROCEDURES: In this prospective, 8-week, multicenter, open-label study, 501 patients were enrolled: mean age 2.9years, male (56.9%), wet/wet ears (66.9%), wet/dry (16.8%), dry/dry (16.3%), and Medicaid-insured (32.9%). MAIN FINDINGS: In per-protocol population (n=410), otorrhea rate through Day 15 were 8.8% (CI:5.7%-12.8%), 6.6% (CI:2.2%-14.7%), 3.3% (CI:0.4%-11.3%) in wet/wet, wet/dry, and dry/dry ears, respectively. For Medicaid patients through Day 15, Week 4 and Week 8, otorrhea rates were 8.1% (CI:4.1%-14.1%), 17.0% (CI:11.1%-24.5%), and 17.8% (CI:11.7%-25.3%) compared with those non-Medicaid insured: 7.3% (CI:4.5%-11.0%), 14.5% (CI:10.6%-19.3%), and 21.8% (CI:17.1%-27.2%), respectively. Safety was similar to previous Phase 3 trials. PRINCIPAL CONCLUSIONS: OTO-201 demonstrated otorrhea rates consistent with Phase 3 trials in a broader, real-world, ENT practice-based pediatric population. Outcomes were similar in Medicaid- and non-Medicaid insured patients. OTO-201 was well-tolerated.
