Ocular Therapeutix™, Inc. (NASDAQ: OCUL) (the “Company”), a
biopharmaceutical company focused on the development, manufacturing
and commercialization of innovative therapies for diseases and
conditions of the eye, today provided an update on legal matters
related to the Company’s manufacture of its product candidate,
DEXTENZA™ (dexamethasone insert) 0.4mg.
As the Company previously disclosed in its periodic filings with
the Securities and Exchange Commission (the “SEC”), including its
most recent Quarterly Report on Form 10-Q filed on November 7,
2017, the Company and certain of its current and former executive
officers and board members were named as defendants in a derivative
lawsuit filed in the Superior Court of Suffolk County of the
Commonwealth of Massachusetts, captioned Angel Madera v. Sawhney et
al., Case No. 17-2273. As previously disclosed, the court dismissed
the Madera lawsuit without prejudice because the plaintiff failed
to serve the complaint in a timely manner under applicable court
rules. On December 21, 2017, the Company was served with a new
derivative complaint that the same plaintiff filed in the same
court, captioned Angel Madera v. Sawhney et al., Case. No.
1784cv04126. The new Madera complaint is premised on substantially
similar allegations as the previous complaint, purports to assert
derivative claims against certain current and former executive
officers and board members for breach of fiduciary duty, unjust
enrichment, and waste of corporate assets, and names the Company as
a nominal defendant. The new Madera complaint also asserts an
unjust enrichment claim against two additional defendants, SV Life
Sciences Fund IV, LP and SV Life Sciences Fund IV Strategic
Partners LP. The Company expects that this new Madera lawsuit will
be consolidated with a second, previously disclosed derivative
lawsuit that asserts similar claims and is pending before the same
court, captioned Robert Corwin v. Sawhney et al., Case No. 17-3425
(BLS2). For more information on the claims alleged by these
lawsuits, please see the Company’s Quarterly Report on Form 10-Q
filed on November 7, 2017. The Company denies any allegations of
wrongdoing and intends to vigorously defend against these
lawsuits.
Additionally, as previously disclosed, the Company and certain
of its current and former executive officers were named as
defendants in three securities class action lawsuits originally
filed in federal court in New Jersey. The court granted the
defendants’ motion to transfer these lawsuits to federal court in
Massachusetts, where the cases are currently pending. The three
lawsuits are captioned Thomas Gallagher v. Ocular Therapeutix, Inc,
et al., Case No. 1:17-cv-12288, Dylan Caraker v. Ocular
Therapeutix, Inc, et al., Case No. 1:17-cv-12146, and Shawna Kim v.
Ocular Therapeutix, Inc, et al., Case No. 1:17-cv-12286. For more
information on the claims alleged by these lawsuits, please see the
Company’s Quarterly Report on Form 10-Q filed on November 7, 2017.
The Company denies any allegations of wrongdoing and intends to
vigorously defend against these lawsuits.
Finally, the Company has received a subpoena from the SEC, dated
December 15, 2017, requesting documents and information concerning
DEXTENZA™ (dexamethasone insert) 0.4mg, including related
communications with the U.S. Food and Drug Administration (“FDA”),
investors and others. The Company intends to fully cooperate with
the SEC regarding this non-public, fact-finding inquiry. The SEC
has informed the Company that this inquiry should not be construed
as an indication that any violations of law have occurred or that
the SEC has any negative opinion of any person, entity or security.
The Company does not intend to comment further on this matter
unless and until this matter is closed or further action is taken
by the SEC which, in the Company’s judgment, merits further comment
or public disclosure.
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 the
reduction of intraocular pressure in patients with glaucoma and
ocular hypertension. The Company’s earlier stage assets include
OTX-TIC, a sustained release travoprost intracameral injection for
the reduction of intraocular pressure in patients with moderate to
severe glaucoma and ocular hypertension, as well as sustained
release intravitreal injections for the treatment of retinal
diseases. These injections include the development of OTX-TKI, a
tyrosine kinase inhibitor (TKI), and, in collaboration with
Regeneron, OTX-TIC, an extended release 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 StatementsAny statements in this press
release about future expectations, plans and prospects for the
Company including potential outcomes or developments in the
Company’s ongoing litigation and SEC inquiry, the development and
regulatory status of the Company’s product candidates, such as the
Company’s expectations and plans regarding product development
efforts and 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 intravitreal depot, the potential
utility of any of the Company’s product candidates, potential
commercialization of the Company’s product candidates, 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 outcome
of any legal actions against us, 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
availability 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/20171222005378/en/
InvestorsWestwicke PartnersChris Brinzey,
339-970-2843Managing Directorchris.brinzey@westwicke.comorOcular
TherapeutixDonald NotmanChief Financial
Officerdnotman@ocutx.comorMediaOcular TherapeutixScott
CorningVice President of Marketing & Commercial
Operationsscorning@ocutx.com
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