No efficacy or safety issues raised by FDA
Outstanding items pertain to manufacturing process and controls
BEDFORD, Mass.--(BUSINESS WIRE)--Jul. 25, 2016--
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 received
a Complete Response Letter (CRL) from the U.S. Food and Drug
Administration (FDA) regarding its New Drug Application (NDA) for
DEXTENZA™ (dexamethasone insert) 0.4 mg, for intracanalicular use in the
treatment of ocular pain occurring after ophthalmic surgery.
The concerns raised by the FDA pertain to deficiencies in manufacturing
process and controls identified during a pre-NDA approval inspection of
the Ocular Therapeutix manufacturing facility. The FDA’s letter did not
provide any details as to which manufacturing deficiencies identified
during the facility inspection remain open since the last response
submitted by the Company.
Satisfactory resolution of the manufacturing deficiencies identified
during the FDA facility inspection is required before the NDA may be
approved. The FDA’s letter did not identify any efficacy or safety
concerns with respect to the clinical data provided in the NDA nor any
need for additional clinical trials for the approval of the NDA.
“We have previously responded to all requests in an effort to address
the manufacturing items raised by the FDA during the application
process, and we await completion of the review,” said Amar Sawhney,
Ph.D., President, Chief Executive Officer and Chairman. “Importantly,
there were no clinical issues identified in the CRL pertaining to
efficacy or safety related to the post-surgical pain indication.
Labeling discussions with the FDA are ongoing. We remain optimistic that
DEXTENZA will be approved once these open manufacturing items are
closed. We will continue to work collaboratively with the FDA so they
can finalize their review of our NDA, and are committed to bringing
DEXTENZA to market as rapidly as possible.”
About DEXTENZA™
DEXTENZA (dexamethasone insert) 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 is pursuing multiple indications for
DEXTENZA, including the treatment of post-surgical ocular pain,
post-surgical ocular inflammation, ocular itching associated with
allergic conjunctivitis, as well as signs and symptoms associated with
inflammatory dry eye disease.
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's lead product candidate,
DEXTENZA™ (dexamethasone insert), is in Phase 3 clinical development for
post-surgical ocular inflammation and pain and allergic conjunctivitis,
and in Phase 2 clinical development for dry eye disease. A third Phase 3
clinical trial is being conducted for post-surgical ocular inflammation
and pain. For glaucoma and ocular hypertension, the Company plans to
initiate the first of two OTX-TP (sustained release travoprost) Phase 3
clinical trials in the third quarter of 2016. Ocular Therapeutix is also
evaluating sustained-release injectable anti-VEGF drug 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 statements about 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 post-surgical ocular inflammation and pain, including our
expectations regarding the pending NDA filed with the FDA, DEXTENZA™ for
the treatment of allergic conjunctivitis, DEXTENZA for 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 and the advancement of the Company's other product
candidates, the potential utility of any of the Company’s product
candidates, 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/20160725005607/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
Ocular
Therapeutix, Inc.
Scott Corning
Vice President of Sales and
Marketing
scorning@ocutx.com
