BEDFORD, Mass.--(BUSINESS WIRE)--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 Statements
Any 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.