Conference Call Today at 5:00pm Eastern Time
BEDFORD, Mass.--(BUSINESS WIRE)--Jul. 10, 2017--
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
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
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/
Source: Ocular Therapeutix, Inc.
Steve Klass, 212-213-0006
Interim Chief Financial Officer
Stephanie Eisenstat, 646-599-8627
Vice President of Marketing &