Clinical stage biopharmaceutical company Otonomy has reported positive data from a Phase Ib study of OTO-201, a sustained-release otic formulation of ciprofloxacin, in paediatric patients undergoing tympanostomy tube placement (TTP) surgery.
According to the data, a single administration of sustained-release antibiotic demonstrated clinically meaningful reduction in post-operative treatment failure as measured by the occurrence of post-operative otorrhea (drainage) or use of rescue antibiotics, by more than 60% compared to control.
Otonomy president and chief executive officer Dr David Weber said the study achieved statistical significance with respect to the cumulative proportion of treatment failures for both OTO-201 dose groups compared to control at two weeks following surgery.
"These results support the clinical utility of OTO-201 given as a single dose at the time of surgery to improve outcomes and eliminate the requirement for post-operative treatment by parents," Weber added.
In the randomised, prospective study, which enrolled 83 paediatric patients between six months and 12 years of age in need of TTP surgery, OTO-201 was well-tolerated at both doses tested.
OTO-201 was administered as a single intra-operative treatment for patients with bilateral middle ear effusion on the day of surgery and the multi-centre, double blind trial tested two dosage strengths, 2% and 6%.
The primary endpoint of the placebo and sham-controlled Phase Ib trial was treatment failure, defined as the presence of otorrhea or use of rescue medication, over the 15-day cumulative period following surgery.
A reduction of treatment failure of more than 60% relative to the placebo/sham group was observed in both OTO-201 active treatment arms.