Otonomy Announces Successful End-of-Phase 2 Review by FDA

Otonomy, Inc. recently announced that it it has successfully completed an End-of-Phase 2 review with the US FDA for OTIPRIO (ciprofloxacin otic suspension) in the treatment of pediatric patients with acute otitis media with tympanostomy tubes (AOMT). Based on this feedback, Otonomy plans to conduct a single, sham controlled, Phase 3 trial enrolling approximately 200 pediatric patients with AOMT to support approval of OTIPRIO for this indication. The timing for initiation of this trial has not yet been determined.

“We are pleased with the outcome of our End-of-Phase 2 communication with the FDA including their acceptance of a single Phase 3 trial to support the registration of OTIPRIO for the treatment of AOMT,” said David A. Weber, PhD, President and CEO of Otonomy. “This feedback is consistent with our previous discussions regarding registration requirements for OTIPRIO in acute otitis externa (AOE) for which we recently submitted a supplemental New Drug Application (sNDA). We believe that, if approved for these indications, AOMT and AOE will more than double the US market opportunity for OTIPRIO, and that OTIPRIO’s single-dose, physician-administered profile is distinct from the current standard of care which, requires multi-dose, multi-day administration of ear drops.”

In October 2016, Otonomy announced the successful completion of a Phase 2 clinical trial that evaluated a single administration of OTIPRIO for the treatment of pediatric patients with AOMT. The 1-month, prospective, randomized, sham-controlled, blinded Phase 2 clinical trial enrolled 95 pediatric patients with unilateral or bilateral AOMT at 12 centers in the US. The trial demonstrated that both OTIPRIO doses evaluated, 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).

According to the American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF), tympanostomy tube placement (TTP) surgery is the most common ambulatory surgery performed on children. Overall, there are approximately one million TTP procedures performed each year in the US of which 85% are in pediatric patients, who typically have middle ear effusion and receive tubes in both ears (bilateral). The tubes are placed for the treatment of persistent or recurrent otitis media (infection and/or inflammation of the middle ear) and can remain in place for a year or more. During this time, recurrent ear infections are common totaling approximately 900,000 cases of acute otitis media with tympanostomy tubes (AOMT) per year in the US. Antibiotic ear drops are considered the standard of care treatment for AOMT with the typical regimen requiring several administrations each day for 7 days.

OTIPRIO (ciprofloxacin otic suspension) is a fluoroquinolone antibacterial indicated for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. OTIPRIO is administered by a physician as a single 0.1 mL (6 mg) intratympanic administration into each affected ear, following suctioning of the middle ear effusion. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed. In two Phase 3 trials, a single intraoperative administration of OTIPRIO demonstrated a statistically significant reduction in the cumulative proportion of study treatment failures compared to tubes alone (p-value <0.001).

Otonomy is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. OTIPRIO (ciprofloxacin otic suspension) is approved in the US for use during tympanostomy tube placement surgery in pediatric patients, an sNDA has been submitted to the FDA for acute otitis externa (AOE) and a successful Phase 2 trial has been completed in patients with acute otitis media with tympanostomy tubes (AOMT). OTIVIDEX (formerly OTO-104) is a steroid in development for the treatment of Ménière’s disease and other balance and hearing disorders. Two Phase 3 trials in Ménière’s disease patients are ongoing, AVERTS-1 in the US and AVERTS-2 in Europe, with AVERTS-1 results expected in the third quarter of 2017 and AVERTS-2 results expected by the end of 2017. In addition, a Phase 2 trial of OTIVIDEX is underway in patients at risk for cisplatin-induced hearing loss. OTO-311 is an NMDA receptor antagonist for the treatment of tinnitus that has completed a Phase 1 clinical safety trial with a Phase 2 trial expected to be initiated in the second half of 2017. A fourth program targeting sensorineural hearing loss including age-related hearing loss is in preclinical development. Otonomy’s proprietary formulation technology utilizes a thermosensitive gel and drug microparticles to enable single-dose treatment by a physician. For more information, visit www.otonomy.com.