Otonomy Announces OTIPRIO™ Data Presentation and Symposium at Combined Otolaryngology Spring Meetings
May 16 2016 - 7:30AM
Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company
focused on the development and commercialization of innovative
therapeutics for diseases and disorders of the ear, today
announced the upcoming presentation of results from an OTIPRIO™
(ciprofloxacin otic suspension) Phase 3b trial as well as the
company’s sponsorship of a symposium related to OTIPRIO during the
Combined Otolaryngology Spring Meetings (COSM) that includes a
meeting of the American Society of Pediatric Otolaryngology (ASPO)
to be held May 20-22, 2016 in Chicago.
Eric Mair, M.D., Charlotte Eye Ear Nose and Throat Associates,
will present the OTIPRIO Phase 3b trial results on Sunday, May 22,
in a presentation titled, “Administration of Extended-Release
Ciprofloxacin Gel after Tympanostomy Tube Placement (TTP) in
Children with Middle Ear Effusion.” Preliminary results from this
open label trial in pediatric patients with bilateral effusion
which evaluated administration of OTIPRIO through the tube during
the TTP procedure were summarized during Otonomy’s Investor Day in
October 2015.
Otonomy Medical Affairs will be sponsoring a symposium and
reception on May 21 titled, “A Clinical Discussion of a New
Perioperative Treatment for Pediatric Patients Undergoing Tube
Placement: Single-dose Thermosensitive Ciprofloxacin Suspension.”
Dr. Eric Mair will serve as the speaker and the symposium will
include a live demonstration of OTIPRIO’s thermosensitive
properties.
In addition, Otonomy will be making two poster presentations.
These are titled, “Development of an Ear Drop Caregiver Burden
Questionnaire (ED-CBQ) for Post Tympanostomy Tube Ear Drop
Administration”, and “Post-Tympanostomy Tube Placement Emergency
Department Visits Among Medicaid-Enrolled and Commercially Insured
Pediatric Populations.” The posters will be displayed on May 20 and
21.
“The breadth of medical activities we are supporting at the COSM
conference demonstrates our commitment to support the clinical
utility of OTIPRIO and advance the pediatric otolaryngology field
through generation of health outcomes data,” said David A. Weber,
Ph.D., president and CEO of Otonomy. “Additionally, this meeting,
which is the largest spring medical conference for U.S.
otolaryngologists, is well-timed for our recent launch of OTIPRIO.
This is the first national venue since commercial launch of OTIPRIO
and will further our ongoing effort to establish broad awareness
and build advocacy with clinicians performing ear tube surgery
procedures.”
About OTIPRIO
OTIPRIO (ciprofloxacin otic suspension) is a fluoroquinolone
antibacterial indicated for the treatment of pediatric 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).
Important Safety Information for OTIPRIO
Contraindications: OTIPRIO is contraindicated
in patients with a history of hypersensitivity to ciprofloxacin, to
other quinolones, or to any of the components of OTIPRIO.
Warnings and Precautions - Potential
for Microbial Overgrowth: OTIPRIO may result in overgrowth
of nonsusceptible bacteria and fungi. If such infections occur,
institute alternative therapy.
Adverse Reactions: Adverse reactions (incidence
at least 3%) that occurred in two Phase 3 trials with OTIPRIO vs
sham were: nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and
rhinorrhea (3% vs 2%).
Use in Specific Populations - Pediatric Use:
The safety and effectiveness of OTIPRIO in infants below six months
of age have not been established.
Full prescribing information can be found at
www.OTIPRIO.com.
About Otonomy
Otonomy is a biopharmaceutical company focused on the
development and commercialization of innovative therapeutics for
diseases and disorders of the ear. OTIPRIO (ciprofloxacin otic
suspension) is approved in the United States for use
during tympanostomy tube placement surgery in pediatric patients,
and commercial launch commenced in March 2016. OTO-104 is a steroid
in development for the treatment of Ménière's disease and other
severe balance and hearing disorders. Two Phase 3 trials in
Ménière's disease patients are underway, with results expected
during the second half of 2017. OTO-311 is an NMDA receptor
antagonist for the treatment of tinnitus that is in a Phase 1
clinical safety trial. Otonomy’s proprietary formulation technology
utilizes a thermosensitive gel and drug microparticles to enable
single dose treatment by a physician. 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 future financial or operating performance of Otonomy.
Forward-looking statements in this press release include, but are
not limited to, the timing of results for the two OTO-104 Phase 3
clinical trials in Ménière's disease. 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: Otonomy's limited
operating history and its expectation that it will incur
significant losses for the foreseeable future; Otonomy's ability to
obtain additional financing; Otonomy's dependence on the commercial
success of OTIPRIO and the regulatory success and advancement of
additional product candidates, such as OTO-104 and OTO-311; 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, 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;
competition in the biopharmaceutical industry; Otonomy's dependence
on third parties to conduct preclinical studies and clinical
trials; the impact of coverage and reimbursement decisions by
third-party payors on the pricing and market acceptance of OTIPRIO;
Otonomy's dependence on third parties for the manufacture of
OTIPRIO and product candidates; Otonomy's dependence on a small
number of suppliers for raw materials; Otonomy's ability to protect
its intellectual property related to OTIPRIO and its product
candidates in the United States and throughout the world;
expectations regarding potential market size, opportunity and
growth; Otonomy's ability to manage operating expenses;
implementation of Otonomy's business model and strategic plans for
its business, products and technology; and other risks. Information
regarding the foregoing and additional risks may be found in the
section entitled "Risk Factors" in Otonomy's Quarterly Report on
Form 10-Q filed with the Securities and Exchange Commission (the
"SEC") on May 9, 2016, 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.
Contacts:
Media Inquiries
Canale Communications
Heidi Chokeir, Ph.D.
Senior 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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