Otonomy, Inc., a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, announced the successful completion of an open-label phase 3b clinical trial that evaluated Otiprio (ciprofloxacin otic suspension) in 501 paediatric patients with a history of otitis media requiring tympanostomy tube placement (TTP) surgery.
The phase 3b trial was designed primarily to evaluate Otiprio in a broader pediatric patient population than the previous phase 3 trials by including patients undergoing common concurrent surgeries and patients without bilateral effusion on the day of surgery. The study also collected patient insurance information to evaluate differences in outcomes for patients with Medicaid versus commercial insurance, and assessed caregiver burden via a questionnaire.
Results of the phase 3b Otiprio trial are as follows:
The incidence of post-operative otorrhea was lower in patients without bilateral effusion and also lower in patients undergoing a concurrent adenoidectomy when compared to patients with bilateral effusion and those undergoing TTP surgery alone, respectively.
The incidence of otorrhea was similar for patients covered by commercial insurance and Medicaid over the eight-week follow-up period.
The incidence of otorrhea reported through day 15 was comparable to the proportion of patients with treatment failure due to otorrhea through day 15 in the Otiprio treated groups of the phase 3 trials.
Otiprio was well tolerated and the adverse event profile was generally comparable to the previous phase 3 trials.
The caregiver survey indicated increased discomfort, lack of confidence, and degree of non-compliance when ear drops were required.
“This study provides important information regarding the use of Otiprio in a patient population that reflects real-world clinical practice and further supports the utility of Otiprio administered as a single intraoperative dose by the physician,” said David A. Weber, Ph.D., president and CEO of Otonomy. “Furthermore, the benefit of assured compliance with Otiprio is highlighted by the increased caregiver burden associated with patients who required antibiotic ear drops, as well as by the similar outcomes measured regardless of the patient's insurance status. This last point is particularly noteworthy given the well-documented observation in other conditions, such as pediatric asthma, that medication adherence is lower and clinical outcomes are generally worse in the Medicaid patient population."
The open-label phase 3b clinical trial enrolled a total of 501 pediatric patients at multiple centers throughout the United States. Patients received a single administration of Otiprio in each ear during TTP surgery. The clinical activity of Otiprio was measured through assessment of the presence of otorrhea, or drainage from the tube. Safety was assessed through adverse event reporting and otoscopic examinations over a two-month follow-up period. This trial also assessed caregiver burden associated with multi-dose, multi-day antibiotic ear drops in the subset of study patients who required ear drops in the post-operative follow-up period.
Otiprio (ciprofloxacin otic suspension) is a fluoroquinolone antibacterial indicated for the treatment of paediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. Otiprio is administered by a physician as a single 0.1 mL (6 mg) intratympanic administration into each affected ear, following suctioning of the middle ear effusion. The thermosensitive suspension exists as a liquid at or below room temperature and gels when warmed. 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).