BEDFORD, Mass.--(BUSINESS WIRE)--Oct. 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 the receipt of a warning letter from the U.S. Food and Drug
Administration (FDA) dated October 17, 2018 and received on October 18,
2018. The letter relates to Ocular’s compliance with data collection and
information reporting obligations in a post-approval Device Exposure
Registry study required as a condition for approval of the premarket
approval (PMA) application for ReSure® Sealant. The Company is required
to provide periodic reports to the FDA on the progress of this
post-approval study until it is completed. The Company has had
discussions with the FDA regarding the conduct of the study and intends
to respond to the warning letter from the FDA within the required 15 day
period.
Ocular Therapeutix takes the warning letter seriously and is committed
to working with the FDA to address and resolve the concerns cited in the
warning letter.
About ReSure® Sealant
ReSure Sealant, a hydrogel ophthalmic wound sealant, is a product
currently indicated for intraoperative management of clear corneal
incisions (up to 3.5mm) with a demonstrated wound leak for which a
temporary dry surface can be achieved, in order to prevent postoperative
fluid egress from such incisions following cataract surgery with
intraocular lens placement in adults.
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 lead product candidate, DEXTENZA® (dexamethasone insert),
has completed Phase 3 clinical development for the treatment of ocular
pain and inflammation following ophthalmic surgery. The New Drug
Application (NDA) for DEXTENZA has a target action date under the FDA
Prescription Drug User Fee Act (PDUFA) of December 28, 2018. OTX-TP
(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 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 the development of 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. 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
post-approval studies of ReSure Sealant, the Company’s expectations
regarding its communications with the FDA regarding such post-approval
studies, including its response to the warning letter regarding ReSure
Sealant, 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 including the conduct of post-approval studies, the
ability to retain regulatory approval of 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
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/20181019005103/en/
Source: Ocular Therapeutix, Inc.
Investors
Ocular Therapeutix
Donald Notman
Chief
Financial Officer
dnotman@ocutx.com
or
Westwicke
Partners
Chris Brinzey, 339-970-2843
chris.brinzey@westwicke.com
or
Media
Ocular
Therapeutix
Scott Corning
Senior Vice President, Commercial
scorning@ocutx.com