Fonseca Biosciences has launched XTORO (finafloxacin otic suspension) 0.3% in the US after receiving FDA approval of the Prior Approval Supplement required for commercial manufacturing.

The decision removes the final regulatory hurdle for commercialisation of the treatment, which is approved for acute otitis externa, commonly known as swimmer’s ear.

XTORO is the first new molecular entity approved for acute otitis externa in more than 20 years and is indicated for infections caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus in patients aged one year and older.

Acute otitis externa affects millions of people in the US each year and is characterised by inflammation and infection of the external ear canal, often causing pain, swelling and tenderness. Although several antibiotic ear drops are available, few new treatment options have reached the market in recent decades.

Mike Luby, founder and chief executive officer of Fonseca Biosciences, said: “Swimmer’s ear, or AOE, is a painful condition that causes significant disruption to daily life, yet there has been little to no innovation in this category for decades. As the first NME approved for AOE in over 20 years, XTORO represents an important treatment option for patients, particularly as antibiotic-resistant cases of AOE continue to emerge.”

XTORO contains finafloxacin, a fluoroquinolone antibiotic formulated as an otic suspension. According to the company, Phase 3 clinical studies demonstrated both clinical and microbiological efficacy, including activity against fluoroquinolone-resistant pathogens and rapid relief of ear pain.

The FDA previously approved XTORO for the treatment of acute otitis externa, with the latest Prior Approval Supplement authorising commercial manufacturing ahead of the product’s US launch.

Alongside the commercial launch, Fonseca Biosciences has introduced an Early Access Resource (EAR) programme that will provide healthcare professionals with treatment samples during the initial launch period while supplies last.

Luby added: “Fonseca is committed to bringing this long-overdue innovation to physicians and patients. Through the EAR Program, healthcare professionals can gain early experience with XTORO in appropriate patients during the initial launch period.”

The launch marks the first commercial product for Fonseca Biosciences as the company begins building its portfolio of specialty pharmaceutical products targeting areas of unmet medical need.