Armed with new phase 3 data, Otonomy plans to file a new indication for Otiprio, its recently launched drug for middle ear infections in children, with the FDA.
The new trial involved patients with acute otitis externa (AOE), a bacterial infection commonly known as swimmer's ear. There are about four million cases of AOE in the U.S. every year, and approval could increase the eligible patient population for Otonomy's drug five-fold and also expand its use beyond ear, nose and throat (ENT) specialists.
The results showed that a single dose of Otiprio—a sustained-release formulation of the antibiotic ciprofloxacin administered using a needle into the external ear canal—resolved 75% of infections within eight days, compared to a 49% clearance rate in patients who underwent a sham treatment.
The positive new trial continues a buoyant period for Otonomy, which has said its portfolio of ear disease treatments, which also includes a candidate for tinnitus, could eventually net $1 billion in annual sales.
The company raised $100 million in an initial public offering (IPO) two years ago and secured FDA approval in late 2015 for Otiprio as a treatment for middle ear infections (otitis media) in children who need to have tympanostomy tubes (grommets) fitted to prevent fluid build-up and hearing problems. There are about 1 million such procedures in the U.S. each year.
Otiprio was launched last March and has been growing slowly—bringing in sales of just $300,000 in the third quarter of 2016.
Otonomy reckons take-up will accelerate thanks in part to the assignment of a permanent Centers for Medicare & Medicaid Services (CMS) "J" code from January 1 this year, which should make it easier to claim reimbursement for the procedure, as well as its own sampling and awareness-raising efforts among ENT physicians. A filing for AOE should take place in the first half of this year, the company said.
Otiprio also has to contend with competition from ear drop antibiotic formulations such as Novartis' Ciprodex, a cheaper ciprofloxacin product that is not specifically approved for use in otitis media grommet procedures but has been used off-label. In the case of swimmer's ear, patients are typically treated with antibiotic ear drops that need to be dosed two to three times a day for a week.
"This trial reinforces Otiprio's unique profile as a single-dose product administered by a physician thereby eliminating the risk of patient non-compliance with the use of multi-dose, multi-day ear drops," said Otonomy's CEO David Webber.
He also pointed out that around 70% of patients in the new trial were treated by non-ENT physicians, which "supports the utility of Otiprio outside the ENT specialist audience."
Meanwhile, Otonomy has also reported data in an expanded tympanostomy tube surgery population, as well as in patients with existing grommets who experience recurrent infections.