The US Food and Drug Administration (FDA) has approved Otonomy, Inc's Otiprio (ciprofloxacin otic suspension) 6% for the treatment of acute otitis externa (AOE) in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus. Otiprio is the first single-dose antibacterial approved by the FDA for treating AOE.
"This approval is an important milestone for the Otiprio programme because it significantly expands the product's commercial potential to include approximately 4 million episodes of AOE per year in the United States, and broadens the target physician population beyond otolaryngologists to paediatricians and primary care physicians who treat the vast majority of AOE cases," said David A. Weber, Ph.D., president and CEO of Otonomy. “This indication also provides an entry point for Otiprio use in the office setting where the single-dose treatment can be administered by a physician or healthcare professional and then billed using an existing J Code. We look forward to incorporating AOE into our ongoing commercial partnering and divestiture discussions."
Acute otitis externa (AOE), also known as swimmer’s ear, is a common condition involving infection and inflammation of the external ear canal typically caused by bacterial infection. According to market data, there are approximately 4 million episodes of AOE each year in the United States. Symptoms include itchiness, redness, swelling, pain and pus draining from the infected ear. Topical antibiotics are considered the standard of care treatment for AOE with the typical regimen of ear drops requiring several administrations to the affected ear each day for up to 10 days.
Otiprio is a sterile, preservative-free, otic suspension of 6% ciprofloxacin administered as a single-dose by a healthcare professional. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed.
For bilateral otitis media with effusion, Otiprio is administered during ear tube surgery as a single 0.1 mL (6 mg) intratympanic administration into each affected ear, following suctioning of the middle ear effusion. 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).
For AOE, Otiprio is administered as a single 0.2 mL (12 mg) administration to the external ear canal of each affected ear. In a single phase 3 trial, Otiprio demonstrated statistically significant clinical response defined as the complete absence of signs and symptoms of AOE (i.e., tenderness, erythema, edema, and otorrhea) compared to sham (p-value < 0.001).
Otiprio (ciprofloxacin otic suspension) is a fluoroquinolone antibacterial indicated for The treatment of pediatric patients 6 months of age and older with bilateral otitis media with effusion undergoing tympanostomy tube placement and The treatment of acute otitis externa in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus.
Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for otology.