NEW ORLEANS, LA – The U.S. Food and Drug Administration (FDA) has approved OTIPRIO® (ciprofloxacin otic suspension) 6% for the treatment of acute otitis externa (AOE), also known as swimmer’s ear, in patients aged 6 months and older. This approval marks the first single-dose antibacterial therapy authorized for AOE and offers physicians a new, convenient option for delivering care. Dr. Patrick Dennis, Principal Investigator at Touro Medical Center in New Orleans, LA, contributed to the pivotal trial through his long-standing partnership with DelRicht Research.

With numerous clinical trials conducted alongside DelRicht Research, Dr. Dennis continues to support the advancement of innovative treatments across multiple therapeutic areas.

A Single-Dose Solution for a Common Condition

Acute otitis externa is a frequent ear infection that causes swelling, pain, redness, and discharge in the outer ear canal. Affecting an estimated 4 million patients annually in the U.S., it is typically treated with multi-day antibiotic ear drops that require careful adherence. OTIPRIO’s approval introduces a single-dose, physician-administered alternative, improving convenience and compliance, especially among pediatric patients.

OTIPRIO is a preservative-free, thermosensitive suspension of ciprofloxacin that gels upon contact with body temperature, allowing for extended drug delivery with just one dose. In its Phase 3 trial, OTIPRIO achieved statistically significant clinical resolution of AOE symptoms compared to placebo, including reduced tenderness, swelling, and discharge.

“We’re proud to support research that improves both outcomes and experience for patients,” said Marshall Morris, Partner at DelRicht Research. “OTIPRIO’s single-dose delivery model represents a major advancement in treating AOE, especially for younger populations and families who struggle with multi-day drop regimens. We’re thrilled that Dr. Dennis and our New Orleans site contributed to this important milestone.”

“OTIPRIO’s single-dose delivery model represents a major advancement in treating AOE, especially for younger populations and families who struggle with multi-day drop regimens. We’re thrilled that Dr. Dennis and our New Orleans site contributed to this important milestone.”

— Marshall Morris, Partner at DelRicht Research

DelRicht Research Investigator on Driving Innovation in Otology

The approval of OTIPRIO also reflects broader innovation in drug delivery within otology. The product’s formulation allows for office-based administration and billing via an existing J Code, enabling more efficient integration into primary care and pediatric settings, where the majority of AOE cases are treated.

“For families dealing with recurring ear infections, ease of use is critical,” said Dr. Patrick Dennis, Principal Investigator. “Participating in the OTIPRIO trial gave us the opportunity to explore a new approach to treatment that minimizes burden and maximizes effectiveness. I’m proud of the role we played in bringing this option forward.”

“For families dealing with recurring ear infections, ease of use is critical. Participating in the OTIPRIO trial gave us the opportunity to explore a new approach to treatment that minimizes burden and maximizes effectiveness. I’m proud of the role we played in bringing this option forward.”

— Dr. Patrick Dennis, Principal Investigator at DelRicht Research

OTIPRIO is also approved for use during tympanostomy tube placement in children with bilateral otitis media with effusion, further expanding its clinical utility in pediatric ENT care. Otonomy, the product’s sponsor, continues to advance a pipeline of ear-focused therapies aimed at improving care for conditions like Ménière’s disease, tinnitus, and hearing loss.

Advancing Patient-Friendly Therapies

The FDA’s approval of OTIPRIO not only introduces a breakthrough therapy for AOE but also underscores the importance of practical, patient-centered innovations in medicine. DelRicht Research is proud to support these efforts through clinical partnerships that prioritize access, efficiency, and real-world impact.

Read the full press release on GlobeNewswire.