Ocular Therapeutix™ Receives FDA Warning Letter Related to ReSure® Sealant
October 19 2018 - 7:50AM
Business Wire
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20181019005103/en/
InvestorsOcular TherapeutixDonald NotmanChief Financial
Officerdnotman@ocutx.comorWestwicke PartnersChris Brinzey,
339-970-2843chris.brinzey@westwicke.comorMediaOcular
TherapeutixScott CorningSenior Vice President,
Commercialscorning@ocutx.com
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