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 that it has dosed the first
patients in a Phase 3 clinical trial of DEXTENZA® (dexamethasone
ophthalmic insert) 0.4 mg for the treatment of post-surgical ocular
inflammation and pain in children following cataract surgery.
“We are pleased to announce the start of a new clinical trial
designed to evaluate the use of DEXTENZA for the treatment of
post-surgical inflammation and pain in children undergoing cataract
surgery,” said Michael Goldstein, MD, MBA, Chief Medical Officer.
“Performing cataract surgery in children represents a different set
of surgical and technical challenges. One area critical to surgical
outcomes is postoperative medication non-compliance. It can be very
challenging to successfully administer topical eye drops to
children particularly when they have recently had surgery. If
approved for pediatric use, DEXTENZA could provide pediatric
ophthalmic surgeons with an interesting product to use to help
their patients.”
The Phase 3 clinical trial is a U.S.-based, randomized,
multicenter clinical trial that intends to enroll approximately 60
subjects between the ages of 0-3 years. The clinical trial is
designed to evaluate the safety and biological activity of DEXTENZA
compared to an active control, prednisolone acetate suspension eye
drops, for the treatment of postoperative inflammation and pain
following ocular surgery for pediatric cataract. This planned
clinical trial is a post-approval requirement of the U.S. Food and
Drug Administration (FDA), in accordance with the Pediatric
Research Equity Act of 2003, in connection with the FDA’s prior
approval of DEXTENZA for the treatment of inflammation and pain
following ophthalmic surgery in adults.
About DEXTENZA
DEXTENZA is FDA approved for the treatment of ocular
inflammation and pain following ophthalmic surgery. DEXTENZA is a
corticosteroid intracanalicular insert placed in the punctum, a
natural opening in the inner portion of the lower eyelid, and into
the canaliculus and is designed to deliver dexamethasone to the
ocular surface for up to 30 days without preservatives. DEXTENZA
resorbs and exits the nasolacrimal system without the need for
removal.
The safety of DEXTENZA was assessed in three Phase 3 clinical
trials and a Phase 2 clinical trial. Overall, 567 subjects were
exposed to DEXTENZA. The most common ocular adverse reactions in
subjects treated with DEXTENZA were: anterior chamber inflammation
including iritis and iridocyclitis (10%), increased intraocular
pressure (6%), reduced visual acuity (2%), cystoid macular edema
(1%), corneal edema (1%), eye pain (1%), and conjunctival hyperemia
(1%). The most common non-ocular adverse event was headache
(1%).
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 inflammation
and pain following ophthalmic surgery. Ocular Therapeutix recently
completed a Phase 3 clinical trial evaluating DEXTENZA for the
treatment of ocular itching associated with allergic
conjunctivitis. The Company’s earlier stage development assets
currently in Phase 1 trials include OTX-TIC (travoprost
intracameral implant) for the reduction of intraocular pressure in
patients with primary open-angle glaucoma and ocular hypertension,
OTX-CSI (cyclosporine intracanalicular insert) for the treatment of
the signs and symptoms of dry eye disease and OTX-TKI (axitinib
intravitreal implant) for the treatment of retinal diseases. Also,
Ocular Therapeutix is currently developing OTX-DED (dexamethasone
intracanalicular insert) for the treatment of episodic dry eye and,
in collaboration with Regeneron, OTX-AFS (aflibercept
suprachoroidal injection) for an extended-delivery formulation of
aflibercept for the treatment of retinal diseases, and 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 DEXTENZA®, ReSure® Sealant, or any of the
Company’s product candidates; the commercial launch of, and
effectiveness of reimbursement codes for, DEXTENZA; the conduct of
post-approval studies of DEXTENZA; the development and regulatory
status of the Company’s product candidates, such as the Company’s
development of and prospects for approvability of DEXTENZA for
additional indications including allergic conjunctivitis, OTX-DED
for the treatment of episodic dry eye disease, OTX-CSI for the
treatment of dry eye disease, 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-AFS as an
extended-delivery formulation of the VEGF trap aflibercept for the
treatment of retinal diseases including wet AMD; the ongoing
development of the Company’s extended-delivery hydrogel depot
technology; the size of potential markets for our product
candidates; 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; projected net product revenue
and other financial metrics of DEXTENZA; the expected impact of the
COVID-19 pandemic on the Company and its operations; 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, the timing and costs involved
in commercializing DEXTENZA, ReSure Sealant or any product
candidate that receives regulatory approval, including the conduct
of post-approval studies, the ability to retain regulatory approval
of DEXTENZA, ReSure Sealant or any product candidate that receives
regulatory approval, the ability to maintain reimbursement codes
for DEXTENZA, 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
Company’s ability to generate its projected net product revenue on
the timeline expected, if at all, 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, the severity and duration
of the COVID-19 pandemic including its effect on the Company’s and
relevant regulatory authorities’ operations, the 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 press 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 except as required by law. 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 press release.
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version on businesswire.com: https://www.businesswire.com/news/home/20200910005310/en/
Investors Ocular Therapeutix Donald Notman Chief
Financial Officer dnotman@ocutx.com
or
Westwicke, an ICR Company Chris Brinzey, 339-970-2843 Managing
Director chris.brinzey@westwicke.com
Media Ocular Therapeutix Scott Corning Senior Vice
President, Commercial scorning@ocutx.com
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