Ocular Therapeutix™ Announces FDA Acceptance of NDA Resubmission for DEXTENZA™ for the Treatment of Ocular Pain Occurring...
23 February 2017 - 12:00AM
Business Wire
PDUFA target action date set for July 19,
2017
DEXTENZA initial target market comprises nearly
4 million cataract surgeries in the U.S.
Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical
company focused on the development and commercialization of
innovative therapies for diseases and conditions of the eye, today
announced that the Company’s New Drug Application (NDA)
resubmission for DEXTENZA™ (dexamethasone insert) 0.4 mg for
intracanalicular use, for the treatment of ocular pain occurring
after ophthalmic surgery has been accepted as a filing for review
by the U.S. Food and Drug Administration (FDA). DEXTENZA is a
product candidate administered by a physician as a bioresorbable
intracanalicular insert and designed for drug release to the ocular
surface for up to 30 days.
The FDA determined that the NDA resubmission is a complete
response and designated the resubmission as a Class 2 review, with
a target action date under the Prescription Drug User Fee Act
(PDUFA) of July 19, 2017 for the potential approval of
DEXTENZA™.
“We are pleased the FDA has accepted our resubmission of the
DEXTENZA NDA and that we now have clarity on the PDUFA target
action date. We look forward to advancing this process toward
our goal of the potential approval and commercial launch of
DEXTENZA,” said Amar Sawhney, Ph.D., President, Chief Executive
Officer and Chairman. “With nearly four million cataract surgeries
performed in the U.S. in 2016 as our initial target, the market
opportunity for DEXTENZA is significant. If approved, we believe
DEXTENZA will be the first non-invasive therapy available to
patients and ophthalmologists that can provide a full
post-operative course of therapy with a single placement.”
About DEXTENZA™
DEXTENZA™ (dexamethasone insert) 0.4mg is placed through the
punctum, a natural opening in the eye lid, into the canaliculus and
is designed to deliver a tapered dose of dexamethasone to the
ocular surface for up to 30 days. Following treatment, DEXTENZA
resorbs and exits the nasolacrimal system without need for removal.
The Company has completed three Phase 3 clinical trials with
DEXTENZA for the treatment of post-surgical ocular inflammation and
pain. Subject to the approval of the NDA for post-surgical ocular
pain by the FDA, Ocular Therapeutix intends to
promptly submit an NDA supplement for DEXTENZA to broaden its label
to include a post-surgical inflammation indication. DEXTENZA is
also in Phase 3 development for the treatment of ocular itching
associated with allergic conjunctivitis.
About Ocular Pain and Inflammation Following Ophthalmic
Surgery
Ocular pain and inflammation are common side effects following
ophthalmic surgery. Physicians prescribe topical corticosteroids as
part of the standard of post-operative care. If left untreated,
inflammation of the eye may result in further ocular complications,
which in some cases may cause permanent loss of vision. According
to US Census data, by the year 2020 it is estimated that the number
of Americans diagnosed with cataracts is expected to rise to
approximately 30 million, representing a 32% increase over current
prevalence estimates.
According to Market Scope, approximately 3.9 million cataract
cases and over 5.6 million total ocular surgeries were expected to
be performed in the United States in 2016.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused
on the development and commercialization of innovative therapies
for diseases and conditions of the eye using its proprietary
hydrogel platform technology. Ocular Therapeutix has resubmitted a
new drug application (NDA) for post-surgical pain for its lead
product candidate, DEXTENZA (dexamethasone insert), which has
completed Phase 3 clinical development for ocular pain and
inflammation following ophthalmic surgery, and the Company is
pursuing additional indications for DEXTENZA. OTX-TP (sustained
release travoprost) is in Phase 3 clinical development for glaucoma
and ocular hypertension. Ocular Therapeutix is also evaluating
injectable drug delivery depots for back-of-the-eye diseases.
Ocular Therapeutix's first product, ReSure® Sealant, is
FDA-approved to seal corneal incisions following cataract
surgery.
Forward Looking Statements
Any statements in this press release about future expectations,
plans and prospects for the Company including the development and
regulatory status of the Company’s product candidates, such as the
Company’s expectations and plans regarding regulatory submissions
for and the timing and conduct of clinical trials of DEXTENZA™ for
the treatment of post-surgical ocular inflammation and pain,
including our expectations regarding the resubmission of the NDA
filed with the FDA and potential FDA approval, DEXTENZA for
the treatment of allergic conjunctivitis, DEXTENZA for the
treatment of inflammatory dry eye disease and OTX-TP for the
treatment of glaucoma and ocular hypertension, the ongoing
development of the Company’s sustained release hydrogel depot
technology, the potential utility of any of the Company’s product
candidates, potential commercialization of the Company’s product
candidates, the potential benefits and future operation of the
collaboration with Regeneron, including any potential future
payments thereunder, the sufficiency of the Company’s cash
resources and other statements containing the words "anticipate,"
"believe," "estimate," "expect," "intend," "goal," "may," "might,"
"plan," "predict," "project," "target," "potential," "will,"
"would," "could," "should," "continue," and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors. Such
forward-looking statements involve substantial risks and
uncertainties that could cause the Company’s clinical development
programs, future results, performance or achievements to differ
significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include,
among others, those related to the timing and costs involved in
commercializing ReSure® Sealant or any product candidate that
receives regulatory approval, the initiation and conduct of
clinical trials, availability of data from clinical trials and
expectations for regulatory submissions and approvals, the
Company’s scientific approach and general development progress, the
availability or commercial potential of the Company’s product
candidates, the sufficiency of cash resources and need for
additional financing or other actions and other factors discussed
in the “Risk Factors” section contained in the Company’s quarterly
and annual reports on file with the Securities and Exchange
Commission. In addition, the forward-looking statements included in
this press release represent the Company’s views as of the date of
this release. The Company anticipates that subsequent events and
developments will cause the Company’s views to change. However,
while the Company may elect to update these forward-looking
statements at some point in the future, the Company specifically
disclaims any obligation to do so. These forward-looking statements
should not be relied upon as representing the Company’s views as of
any date subsequent to the date of this release.
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version on businesswire.com: http://www.businesswire.com/news/home/20170222005519/en/
InvestorsOcular Therapeutix, Inc.Brad SmithChief
Financial Officerbsmith@ocutx.comorBurns McClellan on behalf of
Ocular TherapeutixSteve Klass,
212-213-0006sklass@burnsmc.comorMediaMedical DynamicsCynthia
Sutherland, 646-599-8635Media Group
Directorcsutherland@rxmedyn.comorOcular Therapeutix, Inc.Scott
CorningVice President of Marketing & Commercial
Operationsscorning@ocutx.com
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