Conference Call Today at 5:00pm Eastern
Time
Ocular Therapeutix™, Inc. (NASDAQ:OCUL), a biopharmaceutical
company focused on the development, manufacturing and
commercialization of innovative therapies for diseases and
conditions of the eye, announced today that it has submitted
details of a manufacturing equipment change as an amendment to the
NDA resubmission for DEXTENZA™ (dexamethasone insert) 0.4 mg, for
intracanalicular use, for the treatment of ocular pain following
ophthalmic surgery currently under review by the U.S. Food and Drug
Administration (FDA).
The Company is requesting FDA to consider this submission a
major amendment and extend the current NDA target action date of
July 19, 2017 under the Prescription Drug Fee User Act (PDUFA) by
three months and to review the submission during the current review
cycle. As detailed in the amendment, Ocular Therapeutix has
modified a piece of manufacturing equipment referenced in the NDA
resubmission and will be submitting data on a new commercial batch
to demonstrate that this modification, along with other
improvements, has addressed outstanding issues regarding
particulate matter.
As previously announced, following the completion of a
re-inspection of manufacturing operations by the FDA, Ocular
Therapeutix received an FDA Form 483 in May 2017. This report
contained inspectional observations focused on procedures and
training protocols for manufacturing processes and analytical
testing related to commercial manufacturing of DEXTENZA. The
Company submitted to the FDA its initial corrective action plans
within 15 days of receipt of the Form 483 and has remained in
ongoing communication with the FDA.
On July 10, 2017, Ocular Therapeutix submitted a close-out
response to all inspectional observations included in the FDA Form
483 issued in May 2017. The close-out response focused on the
characterization of particulates, defining and recognizing their
source, implementing appropriate corrective and preventive actions,
and revising training protocols and documents for manufacturing
technicians. Adequate resolution of the outstanding Form 483
inspectional observations is a prerequisite to the approval of the
NDA for DEXTENZA.
The Company follows appropriate industry guidance that permits
specific tolerance levels in batch release qualifications.
Inspection of all DEXTENZA batches has been an integral standard
operating procedure within Ocular’s manufacturing and quality
control processes, with each dose (insert) inspected individually.
Ocular Therapeutix maintains stringent manufacturing standards and
conducts a 100% in-process inspection for DEXTENZA. Any inserts
that do not pass inspection cannot be, and have not been,
considered for either clinical or commercial use.
“We believe that the recent submission of our close-out response
to the Form 483 and subsequent submission of the amendment to our
NDA resubmission for FDA’s consideration can support an acceptable
regulatory pathway for the approval of DEXTENZA,” said Amar
Sawhney, Ph.D., President, Chief Executive Officer and Chairman.
“We continue to be in close communication with the FDA to determine
the best course of action in an effort to successfully bring
DEXTENZA to market.”
About DEXTENZA™ (dexamethasone insert) 0.4 mg for
Intracanalicular Use
DEXTENZA 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 availability of DEXTENZA™ may enable physicians to control
the entire course of steroid therapy following ophthalmic surgery
with a single administration, and reduce patient burden of
administration of topical eye drops. The extended release benefit
of DEXTENZA™ eliminates the need for patients to administer steroid
eye drops in a complex, tapering, multiple-times-a-day therapeutic
regimen over the course of a month, and aims to overcome compliance
issues frequently associated with post-operative medications
following ophthalmic surgery.
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. Based on 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.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will
host a live conference call and webcast today at 5:00 pm
Eastern Time. The live webcast can be accessed by visiting the
Investors section of the Company’s website at investors.ocutx.com.
Please connect at least 15 minutes prior to the live webcast to
ensure adequate time for any software download that may be needed
to access the webcast. Alternatively, please call 844-464-3934
(U.S.) or 765-507-2620 (International) to listen to the live
conference call. The conference ID number for the live call will be
53212491. A replay of the webcast will be available until July
24, 2017 on the Company’s website.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused
on the development, manufacturing 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) 0.4 mg for
intracanalicular use has completed Phase 3 clinical development for
the treatment of ocular pain and inflammation following ophthalmic
surgery. 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.
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 with respect to the manufacturing deficiencies identified
by the FDA and the prospects for approvability of DEXTENZA for
these indications, DEXTENZA for the treatment of allergic
conjunctivitis, DEXTENZA for the treatment of dry eye disease and
OTX-TP for the treatment of glaucoma and ocular hypertension, the
ongoing development of the Company’s sustained release hydrogel
technology, the potential utility of any of the Company’s product
candidates, potential commercialization of the Company’s product
candidates, 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 manufacturing operations, 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/20170710006380/en/
InvestorsBurns McClellanSteve Klass,
212-213-0006sklass@burnsmc.comorOcular TherapeutixGeorge
MigauskyInterim Chief Financial
Officergmigausky@ocutx.comMediaMedical DynamicsStephanie
Eisenstat, 646-599-8627seisenstat@rxmedyn.comorOcular
TherapeutixScott CorningVice President of Marketing &
Commercial Operationsscorning@ocutx.com
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