Outstanding items pertain to Form FDA-483 close-out of manufacturing
deficiencies and analytical testing
No efficacy or safety issues raised by FDA
BEDFORD, Mass.--(BUSINESS WIRE)--Jul. 11, 2017--
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170711006607/en/
Source: Ocular Therapeutix, Inc.
Investors
Burns McClellan
Steve Klass, 212-213-0006
sklass@burnsmc.com
or
Ocular
Therapeutix
George Migausky
Interim Chief Financial Officer
gmigausky@ocutx.com
or
Media
Medical
Dynamics
Stephanie Eisenstat, 646-599-8627
seisenstat@rxmedyn.com
or
Ocular
Therapeutix
Scott Corning
Vice President of Marketing &
Commercial Operations
scorning@ocutx.com
