Otonomy Announces FDA Approval of OTIPRIO(R) for Acute Otitis Externa

Otonomy (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for otology, today announced that the U.S. Food and Drug Administration (FDA) has approved 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.

As quoted in the press release:

“This approval is an important milestone for the OTIPRIO program 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 pediatricians and primary care physicians who treat the vast majority of AOE cases,” said David A. Weber, Ph.D., president and CEO of Otonomy.

Click here to read the full press release.