Receive our newsletter – data, insights and analysis delivered to you
  1. Uncategorized
  2. c-icon icon-chevron-right
August 21, 2013

Otonomy reports positive Phase Ib data of OTO-201 in children undergoing ear tube placement surgery

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.

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%.

Content from our partners
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
Patient-centric pharma logistics: How CRYOPDP delivers hope worldwide
Why Asia-Pacific is the next frontier for decentralized clinical trials

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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU