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%.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.