Ocular Therapeutix™ Receives Complete Response Letter from FDA for DEXTENZA™ NDA
July 11 2017 - 5:00PM
Business Wire
Outstanding items pertain to Form FDA-483
close-out of manufacturing deficiencies and analytical
testing
No efficacy or safety issues raised by
FDA
Ocular TherapeutixTM, 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 received a Complete
Response Letter (CRL) from the U.S. Food and Drug Administration
(FDA), regarding its resubmission of a New Drug Application (NDA)
for DEXTENZA™ (dexamethasone insert) 0.4mg for the treatment of
ocular pain following ophthalmic surgery. The CRL states that the
FDA has determined that it cannot approve the NDA in its present
form.
The CRL from the FDA refers to deficiencies in manufacturing
processes and analytical testing related to manufacture of drug
product for commercial production identified during a pre-NDA
approval inspection of the Ocular
Therapeutix manufacturing facility that was completed in May
2017. As previously announced on July 10, 2017, the Company
submitted a response intended to close out all inspectional
observations included in the Form FDA-483 issued in May 2017. The
Company also submitted details of a manufacturing equipment change
on July 10, 2017 as an amendment to the NDA resubmission and
requested that this be considered a major amendment that would
extend the target action date under the Prescription Drug User Fee
Act (PDUFA).
The CRL acknowledges receipt of the Company’s NDA amendment
dated July 10, 2017 and states that the amendment was not reviewed
prior to the FDA’s action of the CRL. As a result, the FDA did not
have the opportunity to review the Company’s close-out response
prior to issuing the CRL. In addition, as noted in the CRL, the FDA
indicated that applicable sections of the amendment submitted by
Ocular Therapeutix could be incorporated when responding to
deficiencies noted in the CRL.
Satisfactory resolution of the manufacturing deficiencies
detailed in the Form FDA-483 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 for DEXTENZA provided in
the NDA nor any need for additional clinical trials for the NDA
approval.
“We are evaluating the FDA’s response and plan to work closely
with the agency in an effort to satisfy the requirements related to
the NDA,” said Ocular Therapeutix President, Chief Executive
Officer and Chairman, Amar Sawhney, Ph.D. “Importantly, there were
no clinical issues identified in the CRL pertaining to efficacy or
safety related to the post-surgical pain indication. We believe
that DEXTENZA can be approved once these open manufacturing items
are resolved.”
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 without preservatives to the ocular surface for up to
30 days. Following treatment, DEXTENZA resorbs and exits the
nasolacrimal system without need for removal.
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. If the Company’s NDA for the treatment of ocular pain
following ophthalmic surgery is approved, the Company intends to
submit a supplement to its NDA for ocular inflammation. 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170711006607/en/
InvestorsBurns McClellanSteve Klass,
212-213-0006sklass@burnsmc.comorOcular TherapeutixGeorge
MigauskyInterim Chief Financial
Officergmigausky@ocutx.comorMediaMedical DynamicsStephanie
Eisenstat, 646-599-8627seisenstat@rxmedyn.comorOcular
TherapeutixScott CorningVice President of Marketing &
Commercial Operationsscorning@ocutx.com
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