BEDFORD, Mass.--(BUSINESS WIRE)--Jan. 23, 2017--
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 it has
resubmitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for DEXTENZA™ (dexamethasone insert) 0.4 mg, for
the treatment of ocular pain occurring after ophthalmic surgery.
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.
“Following productive discussions with the FDA, we are pleased to
announce the resubmission of our NDA for DEXTENZA for the treatment of
ocular pain occurring after ophthalmic surgery,” said Amar Sawhney,
Ph.D., President, Chief Executive Officer and Chairman. “If DEXTENZA is
approved, we believe that its ability to provide a complete course of
steroid therapy with one-time administration in the post-surgical
setting will be extremely attractive for both ophthalmologists and
patients. We continue to build our commercial organization and
infrastructure in preparation for the earliest possible launch of
DEXTENZA, subject to marketing approval.”
Ocular Therapeutix resubmitted the NDA in response to a complete
response letter (CRL) the Company received from the FDA in July 2016,
which identified items pertaining to deficiencies in manufacturing
process and controls. The Company expects to receive an indication of
the scope and timing of the FDA’s review of the Company’s NDA
resubmission within approximately 30 days. The Company believes that the
FDA review period of the NDA resubmission will be up to two months if a
Class 1 (minor review) designation is received and up to six months if a
Class 2 (major review) designation is received. Class 1 or 2 designation
is dependent on whether an FDA re-inspection of the Ocular Therapeutix
manufacturing facility will be a condition of NDA approval.
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 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
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 ocular surgeries were performed in the United States in
2016.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. (NASDAQ: OCUL) 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 an NDA for
post-surgical pain for its lead product candidate, DEXTENZA™
(dexamethasone insert) 0.4mg, which has completed Phase 3 clinical
development for post-surgical ocular inflammation and pain. Subject to
the approval of the NDA for post-surgical ocular pain, Ocular
Therapeutix intends to submit a supplemental NDA for DEXTENZA to broaden
its label to include an indication for post-surgical inflammation.
DEXTENZA is also in Phase 3 clinical development for allergic
conjunctivitis. OTX-TP (travoprost insert) 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. For
additional information about the Company, please visit www.ocutx.com.
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 NDA filed with the FDA and the FDA’s response to the
resubmitted NDA, 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 Company’s
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170123005540/en/
Source: Ocular Therapeutix, Inc.
Investors
Ocular Therapeutix, Inc.
Brad Smith
Chief
Financial Officer
bsmith@ocutx.com
or
Burns
McClellan on behalf of Ocular Therapeutix
Steve Klass, 212-213-0006
sklass@burnsmc.com
or
Media
Medical
Dynamics
Cynthia Sutherland, 646-599-8635
Media Group Director
csutherland@rxmedyn.com
or
Ocular
Therapeutix, Inc.
Scott Corning
Vice President of Marketing &
Commercial Operations
scorning@ocutx.com