OTIPRIO is a physician administered, single dose formulation of ciprofloxacin in development for the treatment of patients with acute otitis media with tympanostomy tubes.
Acute Otitis Media with Tympanostomy Tubes (AOMT) Program
We have successfully completed a Phase 2 trial of OTIPRIO in pediatric patients with AOMT. This trial demonstrated that both OTIPRIO doses, 6 mg (0.1 mL) and 12 mg (0.2 mL), were well-tolerated and achieved higher and statistically significant (p<0.05) clinical cure rates over sham (no treatment). In June 2017, we successfully completed an End-of-Phase 2 review with the FDA supporting that a single, sham-controlled, pivotal Phase 3 trial enrolling approximately 200 pediatric patients with AOMT is sufficient to support approval of OTIPRIO for this indication. The timing for initiation of this trial has not yet been determined.