Fonseca Biosciences Gains Exclusive U.S. Rights to XTORO® for Swimmer's Ear Treatment

Fonseca Biosciences has entered into an agreement with MerLion Pharmaceuticals GmbH to exclusively market and distribute XTORO® (finafloxacin otic suspension) 0.3% in the United States. This announcement is significant for the millions of Americans who suffer from acute otitis externa (AOE), commonly known as swimmer's ear. Fonseca is preparing to introduce a new therapeutic option, XTORO, which has already received approval from the US Food and Drug Administration (FDA) for treating AOE.

The active component in XTORO, finafloxacin, is a next-generation fluoroquinolone that offers extensive microbiological activity against the primary pathogens responsible for AOE, including those resistant to other fluoroquinolones. Clinical studies have demonstrated that XTORO provides rapid relief of symptoms and maintains clinical efficacy at the test of cure, along with a favorable safety and tolerability profile.

Although XTORO is FDA-approved, it has not yet been launched in the US market. Fonseca has submitted a Prior Approval Supplement to the FDA to secure US marketing authorization. Subject to FDA approval, Fonseca anticipates commencing distribution of XTORO by mid-2025.

Mike Luby, the Founder and CEO of Fonseca Biosciences, emphasized the company's dedication to bringing therapies that make a tangible difference to the market. He highlighted that XTORO represents a major advancement for patients suffering from swimmer’s ear by providing quick relief and addressing a critical unmet medical need. Luby encouraged the public to stay informed about updates as Fonseca gears up to launch XTORO in mid-2025, aiming to alleviate the condition for millions of individuals across the United States.

XTORO is indicated for the treatment of acute otitis externa (AOE) caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus in patients ages one year and older. There are no listed contraindications for XTORO. However, prolonged use of the product may result in the overgrowth of nonsusceptible organisms, requiring discontinuation if this occurs. Additionally, allergic reactions may happen in patients with a history of hypersensitivity to finafloxacin, other quinolones, or any components of the medication, necessitating a stoppage of use if this occurs.

The most commonly reported adverse reactions, affecting 1% of patients using XTORO, include ear itching and nausea.

Fonseca Biosciences is a privately held life sciences company dedicated to transforming pharmaceutical commercialization. The company focuses on bringing innovative therapies to market that meet critical unmet needs. Fonseca prides itself on a visionary approach, experienced leadership, and a strong commitment to rapid and effective execution, bridging the gap between discovery and delivery. Through this strategy, Fonseca aims to turn potential into significant impact in the pharmaceutical industry.