BEDFORD, Mass.--(BUSINESS WIRE)--Apr. 30, 2019--
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 settled litigation with Mati Therapeutics, Inc.,
regarding alleged infringement of U.S. Patent 7,922,702. Both parties
have dismissed all claims and counterclaims against each other in that
litigation, which was pending in the United States District Court for
the District of Delaware (Ocular Therapeutix, Inc. v. Mati
Therapeutics, Inc., Case No. 1:18-cv-01991-MN). Ocular had sought a
declaration from the court that its first commercial drug product,
DEXTENZA®, does not infringe Mati’s U.S. Patent 7,922,702.
Under the settlement, Mati did not grant a patent license. Instead, both
parties granted to each other a limited covenant not to sue regarding
infringement by DEXTENZA, only as approved under New Drug Application
number 208742. As such, there were no financial considerations by either
party. All other terms of settlement are confidential.
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’s first
commercial drug product, DEXTENZA, is FDA-approved for the treatment of
ocular pain following ophthalmic surgery. OTX-TP (intracanalicular
travoprost insert) is an intracanalicular insert 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 intracameral
travoprost 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, containing a tyrosine kinase
inhibitor (TKI), and, in collaboration with Regeneron, OTX-IVT, an
extended-delivery protein-based anti-vascular endothelial growth factor
(VEGF) trap. 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 commercialization of DEXTENZA, ReSure Sealant or any of
the Company’s product candidates, including the anticipated commercial
launch of, and the receipt of reimbursement codes for, DEXTENZA; 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 inflammation and the prospects
for approvability of DEXTENZA for post-surgical ocular inflammation or
any other 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 Company’s
post-approval studies of ReSure Sealant and the Company’s ongoing
communications with the U.S. Food and Drug Administration regarding the
warning letter the Company received regarding ReSure Sealant; the
ongoing development of the Company’s extended-delivery hydrogel depot
technology; the potential utility of any 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 DEXTENZA, ReSure Sealant or any product candidate that
receives regulatory approval, including the conduct of post-approval
studies, the ability to retain regulatory approval of DEXTENZA, ReSure
Sealant or any product candidate that receives regulatory approval, the
ability to obtain reimbursement codes for DEXTENZA, 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 Company’s
existing indebtedness, the ability of the Company’s creditors to
accelerate the maturity of such indebtedness upon the occurrence of
certain events of default, 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 except as required by law. 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/20190430005235/en/
Source: Ocular Therapeutix, Inc.
Investors
Ocular Therapeutix
Donald Notman
Chief
Financial Officer
dnotman@ocutx.com
or
Westwicke, an ICR Company
Chris Brinzey, 339-970-2843
Managing
Director
chris.brinzey@westwicke.com
Media
Ocular Therapeutix
Scott Corning
Senior Vice
President, Commercial
scorning@ocutx.com