PDUFA target action date set for July 19, 2017
DEXTENZA initial target market comprises nearly 4 million cataract
surgeries in the U.S.
BEDFORD, Mass.--(BUSINESS WIRE)--Feb. 22, 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 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.”
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170222005519/en/
Source: Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc.
McClellan on behalf of Ocular Therapeutix
Steve Klass, 212-213-0006
Cynthia Sutherland, 646-599-8635
Media Group Director
Vice President of Marketing &