XTORO is a New Chemical Entity that is FDA approved for the treatment of acute otitis externa, commonly known as “swimmer’s ear”, caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus
LONG BEACH TOWNSHIP, N.J.--(BUSINESS WIRE)--Fonseca Biosciences (“Fonseca”) announced today an agreement with MerLion Pharmaceuticals GmbH granting Fonseca the exclusive rights to market and distribute XTORO® (finafloxacin otic suspension) 0.3% in the United States. Millions of Americans suffer from acute otitis externa (AOE), better known as swimmer’s ear. Fonseca is stepping up to deliver a new option, XTORO, which is approved by the US Food and Drug Administration (FDA) for the treatment of AOE.
Finafloxacin, the active ingredient in XTORO, is an advanced-generation fluoroquinolone that demonstrates broad spectrum microbiological activity against key AOE pathogens, including organisms resistant to other fluoroquinolones. In clinical studies XTORO provided rapid symptom relief and sustained clinical efficacy at test of cure, with a favorable safety and tolerability profile.
XTORO is FDA approved but has not launched in the US. Fonseca has submitted a Prior Approval Supplement to the FDA seeking US marketing authorization. Subject to FDA approval of Fonseca’s application, Fonseca expects to begin distribution of XTORO in mid-2025.
“At Fonseca Biosciences, we are passionate about commercializing therapies that truly make a difference. XTORO® represents a significant step forward for patients with swimmer’s ear, offering rapid relief and addressing a critical unmet need,” said Mike Luby, Founder and CEO of Fonseca. “Stay tuned for updates as Fonseca prepares to launch XTORO® in mid-2025, helping to bring relief to millions across the US.”
About XTORO®
Important Safety Information
- Indications and Usage:
˗ Xtoro® (finafloxacin otic suspension), 0.3% is a quinolone antimicrobial indicated for the treatment of acute otitis externa (AOE) with or without an otowick, caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus in patients age 1 year and older.
- Contraindications: None
- Warnings and Precautions:
˗ Prolonged use of this product may lead to overgrowth of nonsusceptible organisms. Discontinue use if this occurs.
˗ Allergic reactions may occur in patients with a history of hypersensitivity to finafloxacin, to other quinolones, or to any of the components in this medication. Discontinue use if this occurs.
- Adverse Reactions: The most common adverse reactions occurring in 1% of patients with XTORO were ear pruritus and nausea.
About Fonseca
Fonseca Biosciences is redefining pharmaceutical commercialization for a new era. As a privately held life sciences company, we specialize in bringing innovative therapies to market that fulfill critical unmet needs. With a visionary playbook, seasoned leadership, and an unwavering commitment to rapid and effective execution, we bridge the gap between discovery and delivery—turning potential into profound impact. Discover how Fonseca Biosciences is redefining what’s possible at www.fonsecabio.com.
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