sNDA Expands the Current DEXTENZA®
Post-Operative Pain Label as the First Intracanalicular Insert for Drug
Delivery
BEDFORD, Mass.--(BUSINESS WIRE)--Jan. 10, 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 the submission of a supplemental New Drug Application (sNDA)
to the U.S. Food and Drug Administration (FDA) for DEXTENZA
(dexamethasone ophthalmic insert). The sNDA filing seeks to expand the
current indication for DEXTENZA to include the treatment of ocular
inflammation following ophthalmic surgery. The Company expects that the
FDA review will be completed in the second half of 2019.
DEXTENZA is the first FDA-approved intracanalicular insert delivering
dexamethasone to treat post-surgical ocular pain for up to 30 days with
a single administration. DEXTENZA received FDA approval in November 2018
for the treatment of ocular pain following ophthalmic surgery. DEXTENZA
is a resorbable, preservative-free ophthalmic insert that is placed in
the lower lacrimal punctum and into the canaliculus of the eye.
“Submission of this sNDA on the heels of the initial DEXTENZA approval
is another significant milestone for Ocular Therapeutix. The potential
market opportunity for postoperative ocular pain and inflammation is
substantial and there remains an important unmet need to address the
issue of non-compliance given currently available treatment options,”
said Antony Mattessich, the Company’s President and Chief Executive
Officer. “This is another major step toward our goal of making eye-drop
therapies obsolete.”
The sNDA is supported by the two previous Phase 3 clinical trials and
safety and efficacy data from an additional prospective, multicenter,
randomized, controlled Phase 3 clinical trial of DEXTENZA (n=438) in
cataract surgery patients that demonstrated statistical significance
compared to the vehicle control for the endpoints of absence of ocular
pain (p<0.0001) and absence of inflammation (p<0.0001). The ocular
safety profile was similar to that demonstrated in the two prior Phase 3
clinical trials. Data from the third Phase 3 clinical trial were
recently published in the Journal of Cataract & Refractive Surgery
(JCRS) in October 2018.
In connection with the approval and anticipated commercial launch of
DEXTENZA, Ocular Therapeutix has also submitted an application to
Centers for Medicare & Medicaid Services (CMS) for transitional
pass-through payment status and an application for a J-code.
Current DEXTENZA® Indication and Important
Safety Information
DEXTENZA® (dexamethasone ophthalmic insert) is a
corticosteroid indicated for the treatment of ocular pain following
ophthalmic surgery.
DEXTENZA is contraindicated in patients with active corneal,
conjunctival or canalicular infections, including epithelial herpes
simplex keratitis (dendritic keratitis), vaccinia, and varicella;
mycobacterial infections; fungal diseases of the eye; and dacryocystitis.
Prolonged use of corticosteroids may result in glaucoma with damage to
the optic nerve, defects in visual acuity and fields of vision. Steroids
should be used with caution in the presence of glaucoma and intraocular
pressure should be monitored during treatment.
Corticosteroids may suppress the host response and thus increase the
hazard for secondary ocular infections. In acute purulent conditions,
steroids may mask infection and enhance existing infection.
Use of ocular steroids may prolong the course and may exacerbate the
severity of many viral infections of the eye (including herpes simplex).
Fungus invasion must be considered in any persistent corneal ulceration
where a steroid has been used or is in use. Fungal culture should be
taken when appropriate.
Use of steroids after cataract surgery may delay healing and increase
the incidence of bleb formation.
Please see Important Safety Information and Full Prescribing Information
at www.DEXTENZA.com
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 ReSure Sealant, DEXTENZA®
or any of the Company’s product candidates; 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 Company’s appeal of the warning letter it 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 ReSure Sealant, DEXTENZA or any product candidate that
receives regulatory approval, including the conduct of post-approval
studies, the ability to retain regulatory approval of ReSure Sealant,
DEXTENZA or any product candidate that receives regulatory approval, 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. 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/20190110005690/en/
Source: Ocular Therapeutix
Investors
Ocular Therapeutix
Donald Notman
Chief
Financial Officer
dnotman@ocutx.com
or
Westwicke
Partners
Chris Brinzey
Managing Director
chris.brinzey@westwicke.com
Media
Ocular Therapeutix
Scott Corning
Senior Vice
President, Commercial
scorning@ocutx.com
