PDUFA date is set for December 28, 2018
BEDFORD, Mass.--(BUSINESS WIRE)--Jul. 19, 2018--
Ocular Therapeutix™, Inc. (NASDAQ: OCUL), a biopharmaceutical company
focused on the formulation, development, and commercialization of
innovative therapies for diseases and conditions of the eye, today
announced that it has received acknowledgement from the U.S. Food and
Drug Administration (FDA) that the New Drug Application (NDA) for
DEXTENZA® has been received. DEXTENZA (dexamethasone insert) 0.4mg is
Ocular Therapeutix’s lead product candidate for the treatment of ocular
pain following ophthalmic surgery. The FDA considers the NDA
resubmission as a class 2 response to its July 2017 Complete Response
Letter with a PDUFA (Prescription Drug User Fee Act) target date of
December 28, 2018 for the completion of the FDA’s review of the DEXTENZA
NDA.
“We are pleased with the recent news that the FDA has formally accepted
our resubmission of the DEXTENZA NDA,” said Antony Mattessich, President
and Chief Executive Officer. “This marks one more important step towards
our goal of bringing this important new treatment to the market.”
About DEXTENZA®
DEXTENZA is a corticosteroid
intracanalicular insert 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 without
preservatives. Following treatment, DEXTENZA is intended to resorb and
exit the nasolacrimal system without the need for removal. DEXTENZA has
completed Phase 3 evaluation for the treatment of ocular pain and
inflammation following ophthalmic surgery. Upon approval for pain, the
Company intends to submit an NDA supplement for the treatment of
inflammation following ocular surgery. DEXTENZA is also in Phase 3
clinical development for allergic conjunctivitis.
About Ocular Therapeutix™, Inc.
Ocular Therapeutix,
Inc. is a biopharmaceutical company focused on the formulation,
development, and commercialization of innovative therapies for diseases
and conditions of the eye using its proprietary bioresorbable
hydrogel-based formulation technology. Ocular Therapeutix has
resubmitted an NDA for post-surgical pain for its lead product
candidate, DEXTENZA® (dexamethasone insert), which 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 the reduction of intraocular pressure in
patients with primary open-angle glaucoma and ocular hypertension. The
Company’s earlier stage assets include OTX-TIC, an extended-delivery
travoprost intracameral implant for the reduction of intraocular
pressure in patients with glaucoma and ocular hypertension, as well as
sustained release intravitreal implants for the treatment of retinal
diseases. These intravitreal implants include OTX-TKI, a tyrosine kinase
inhibitor (TKI), and, in collaboration with Regeneron, OTX-IVT, an
extended-delivery protein-based anti-vascular endothelial growth factor
(VEGF) trap, both for the treatment of retinal 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 regulatory submissions for and the
timing and conduct of, or implications of results from, clinical trials
of DEXTENZA™ for the treatment of post-surgical ocular pain and
inflammation, including with respect to manufacturing deficiencies
identified by the FDA, the Company’s expectations regarding the NDA
filed with the FDA, the FDA’s response to the resubmitted NDA and the
prospects for approvability of DEXTENZA for these indications, OTX-TP
for the treatment of primary open-angle glaucoma and ocular hypertension,
OTX-TIC for the treatment of primary open-angle glaucoma and ocular
hypertension, OTX-TKI for the treatment of retinal diseases including
wet AMD, and OTX-IVT as an extended-delivery formulation of the VEGF
trap aflibercept for the treatment of retinal diseases including wet
AMD; the ongoing development of the Company’s extended-delivery hydrogel
depot technology; the potential utility of any of the Company’s product
candidates; potential commercialization of the Company’s product
candidates; the potential benefits and future operation of the
collaboration with Regeneron Pharmaceuticals, including any potential
future payments thereunder; 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, timing 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, the outcome of the Company’s ongoing legal proceedings 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: https://www.businesswire.com/news/home/20180719005161/en/
Source: Ocular Therapeutix
Investors
Ocular Therapeutix
Donald Notman
Chief
Financial Officer
dnotman@ocutx.com
or
Westwicke
Partners
Chris Brinzey
Managing Director
chris.brinzey@westwicke.com
or
Media
Ocular
Therapeutix
Scott Corning
Senior Vice President, Commercial
scorning@ocutx.com
