Otonomy Presents AuriPro(TM) Phase 3 Results at American Society of Pediatric Otolaryngology Conference
April 27 2015 - 7:30AM
Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical
company focused on the development and commercialization of
innovative therapeutics for diseases and disorders of the inner and
middle ear, today announced that results from two identical Phase 3
trials of AuriPro™ were presented at the annual American Society of
Pediatric Otolaryngology (ASPO) meeting, held during the Combined
Otolaryngology Spring Meetings in Boston. This data supports
Otonomy's New Drug Application (NDA) that has been submitted to the
U.S. Food and Drug Administration (FDA) for the approval of AuriPro
as a treatment of middle ear effusion in pediatric patients
undergoing tympanostomy tube placement (TTP) surgery.
Results of these prospective, randomized, double-blind,
sham-controlled Phase 3 trials demonstrated that AuriPro achieved
the primary efficacy endpoint, reduction in the incidence of
treatment failures, with statistical significance (p<0.001) and
that AuriPro was well tolerated. In these trials, AuriPro reduced
the risk of treatment failure, as measured by the occurrence of
post-operative otorrhea (drainage) or any use of rescue
antibiotics, by an average of 49 percent in all randomized patients
across the two trials, and the rate of post-operative otorrhea or
use of rescue antibiotics for documented otorrhea or otitis media
by an average of 62 percent in all randomized patients across the
two trials (p≤ 0.004), in each case as compared to sham. The
studies enrolled a combined total of 532 pediatric patients.
"These two AuriPro Phase 3 trials are the first large-scale,
multi-center studies demonstrating the clinical importance of
antibiotic administration to reduce the occurrence of
post-operative complications such as otorrhea following ear tube
placement surgery," said Eric Mair, M.D., of Charlotte Eye Ear Nose
& Throat Associates. "These results also demonstrate that a
single dose of AuriPro, administered by the ENT during the
procedure, provides a full course of treatment and avoids the risk
of compliance problems inherent to multi-dose, multi-day, off-label
antibiotic ear drops given by the parent or caregiver."
The presentation titled "Results Of Two Phase 3 Clinical Trials
To Assess The Safety And Efficacy Of Extended-Release Ciprofloxacin
Gel For Intratympanic Administration In Children With Middle Ear
Effusion Undergoing Tympanostomy Tube Placement" was delivered by
Dr. Mair.
About AuriPro
AuriPro is a sustained-exposure formulation of the antibiotic
ciprofloxacin in development for the treatment of middle ear
effusion in pediatric patients undergoing tympanostomy tube
placement (TTP) surgery. AuriPro has been formulated to provide
sustained-exposure of ciprofloxacin so that a single administration
provides a full course of treatment. There are approximately one
million TTP surgeries performed each year in the United States, and
antibiotic ear drops are used in nearly all cases. Despite their
routine use, no antibiotic ear drop has received FDA approval for
this indication. Moreover, current ear drop products require
multi-dose, multi-day regimens for efficacy. Full compliance with
these regimens can be challenging, and missed antibiotic doses can
compromise efficacy and increase the potential for bacterial
resistance.
Otonomy submitted a New Drug Application (NDA) for AuriPro for
the treatment of middle ear effusion in pediatric patients
undergoing TTP surgery to the FDA on February 25, 2015. If approved
within the standard review period, Otonomy anticipates a commercial
launch for AuriPro in the United States in the first quarter of
2016.
About Otonomy
Otonomy is a clinical-stage biopharmaceutical company focused on
the development and commercialization of innovative therapeutics
for diseases and disorders of the ear. Otonomy's proprietary
technology provides sustained exposure of drugs to the middle and
inner ear following a single intratympanic injection. Otonomy has
three product candidates in development. AuriPro™ is an antibiotic
that has completed Phase 3 clinical trials in pediatric patients
with middle ear effusion at the time of tympanostomy tube placement
surgery, and a New Drug Application for AuriPro in this indication
has been submitted to the FDA. OTO-104 is a steroid that is in the
first of two pivotal clinical studies for the treatment of patients
with Ménière's disease. OTO-311 is an NMDA receptor antagonist in
development as a treatment for tinnitus. For additional information
please visit www.otonomy.com.
Cautionary Note Regarding Forward Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements generally relate to future events
or Otonomy's future financial or operating performance.
Forward-looking statements in this press release include, but are
not limited to, Otonomy's expectations regarding the commercial
launch of AuriPro in the United States. Otonomy's expectations
regarding these matters may not materialize, and actual results in
future periods are subject to risks and uncertainties. Actual
results may differ materially from those indicated by these
forward-looking statements as a result of these risks and
uncertainties, including but not limited to: the uncertainties
inherent in the clinical drug development process, including,
without limitation, Otonomy's ability to adequately demonstrate the
safety and efficacy of its product candidates, the preclinical and
clinical results for its product candidates, which may not support
further development of product candidates, and challenges related
to patient enrollment in clinical trials; Otonomy's ability to
obtain regulatory approval for its product candidates; side effects
or adverse events associated with Otonomy's product candidates;
developments related to competitors and the industry; Otonomy's
dependence on third parties to conduct preclinical studies and
clinical trials; Otonomy's dependence on third parties for the
manufacture of products; Otonomy's dependence on a small number of
suppliers for raw materials; Otonomy's ability to protect its
intellectual property related to product candidates in the United
States and throughout the world; and other risks. Information
regarding the foregoing and additional risks may be found in the
section entitled "Risk Factors" in Otonomy's Annual Report on Form
10-K filed with the Securities and Exchange Commission (the SEC) on
March 18, 2015, and Otonomy's future reports to be filed with the
SEC. The forward-looking statements in this press release are based
on information available to Otonomy as of the date hereof. Otonomy
disclaims any obligation to update any forward-looking statements,
except as required by law.
CONTACT: Media Inquiries
Canale Communications
Heidi Chokeir, Ph.D.
Vice President
619.849.5377
heidi@canalecomm.com
Investor Inquiries
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com
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