BEDFORD, Mass.--(BUSINESS WIRE)--Mar. 15, 2017--
Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company
focused on the development, manufacturing and commercialization of
innovative therapies for diseases and conditions of the eye, today
announced positive results of a patient experience study of DEXTENZA™
(dexamethasone insert) 0.4 mg for intracanalicular use. The study,
published in Patient Preference and Adherence, evaluated the
overall patient experience and perceived value of DEXTENZA following
DEXTENZA is a hydrogel-based drug-eluting intracanalicular insert that
incorporates the U.S. Food and Drug Administration (FDA)-approved
corticosteroid, dexamethasone, as the active ingredient. Inserted
non-invasively through the punctum, DEXTENZA resides within the
canaliculus and delivers dexamethasone to the ocular surface for
approximately 30 days. Following the completion of treatment, DEXTENZA
resorbs and exits the nasolacrimal system without need for removal.
The goal associated with DEXTENZA is to reduce the patient burden of
administration of topical eye drops following ophthalmic surgery by
enabling the physician to control the entire course of steroid therapy
with a single administration. The extended release benefit of DEXTENZA
replaces the need for patients to administer steroid eye drops in a
complex, tapering, several-times-a-day regimen over the course of a
month. In parallel, DEXTENZA aims to remove the issues commonly
associated with non-compliance of post-operative medications following
A New Drug Application (NDA) for DEXTENZA is currently under review by
the FDA for the treatment of ocular pain occurring after ophthalmic
surgery. The FDA has set a PDUFA target action date for July 19, 2017.
The patient experience retrospective study was conducted with 25
patients who had received active treatment in the Company’s Phase 3
clinical trials of DEXTENZA for the treatment of post-surgical ocular
pain and inflammation.
All patients reported that the intracanalicular insert was comfortable.
Ninety-six percent (96%) felt the insert was extremely or very
convenient compared to topical eye drops on a tapered schedule.
Ninety-two percent (92%) reported the highest level of overall product
satisfaction, with eighty-eight percent (88%) saying they would
request the insert if they were to undergo cataract surgery again.
Ninety-two percent (92%) of patients surveyed said they would
recommend DEXTENZA to friends or family members.
“We are encouraged by the experiences these patients shared, which add
another dimension to the clinical results achieved in the Phase 3
clinical trials,” said Jonathan H. Talamo, M.D., Chief Medical Officer
of Ocular Therapeutix. “If approved, we believe that DEXTENZA, which
incorporates the Company’s proprietary hydrogel platform technology,
will offer an attractive alternative to the current post-operative
standard of care of steroid eye drops for those recovering from
In the Company’s third and most recent Phase 3 clinical trial, DEXTENZA
successfully met the two primary efficacy endpoints, absence of ocular
pain on day 8 and absence of ocular inflammation on day 14, when
compared to placebo. DEXTENZA has exhibited a favorable safety profile
and has been well tolerated in all clinical trials, regardless of
indication. Subject to the approval of the NDA for post-surgical ocular
pain by the FDA, Ocular Therapeutix intends to submit an NDA supplement
for DEXTENZA to broaden its label to include a post-surgical
DEXTENZA™ (dexamethasone insert) 0.4mg for
intracanalicular use is placed through the punctum, a natural opening in
the eye lid, into the canaliculus and is designed to deliver
dexamethasone to the ocular surface for up to 30 days. Following
treatment, DEXTENZA resorbs and exits the nasolacrimal system without
need for removal. The Company has completed three Phase 3 clinical
trials with DEXTENZA for the treatment of post-surgical ocular
inflammation and pain.
In January, Ocular Therapeutix resubmitted an NDA to the FDA for
DEXTENZA for the treatment of ocular pain occurring after ophthalmic
surgery. The FDA has set a PDUFA target action date for July 19, 2017.
Subject to the approval of the NDA for post-surgical ocular pain by
the FDA, Ocular Therapeutix intends to submit an NDA supplement for
DEXTENZA to broaden its label to include a post-surgical inflammation
indication. DEXTENZA is also in Phase 3 development for the treatment of
ocular itching associated with allergic conjunctivitis.
About Ocular Pain and Inflammation Following Ophthalmic Surgery
pain and inflammation are common side effects following ophthalmic
surgery. Physicians prescribe topical corticosteroids as part of the
standard of post-operative care. If left untreated, inflammation of the
eye may result in further ocular complications, which in some cases may
cause permanent loss of vision. According to US Census data, by the year
2020 it is estimated that the number of Americans diagnosed with
cataracts is expected to rise to approximately 30 million, representing
a 32% increase over current prevalence estimates.
According to Market Scope, approximately 3.9 million cataract cases and
over 5.6 million ocular surgeries were performed in the United States in
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) 0.4mg for intracanalicular use has completed
Phase 3 clinical development for the treatment of ocular pain and
inflammation occurring after ophthalmic surgery. The FDA has accepted
the Company’s NDA resubmission for DEXTENZA for the treatment of ocular
pain occurring after ophthalmic surgery and has established a target
PDUFA date of July 19, 2017. Ocular Therapeutix is also pursuing
additional indications for DEXTENZA. OTX-TP (travoprost insert) is in
Phase 3 clinical development for glaucoma and ocular hypertension.
Ocular Therapeutix is also evaluating injectable drug delivery depots
for back-of-the-eye diseases. Ocular Therapeutix's first product, ReSure®
Sealant, is FDA-approved to seal corneal incisions following cataract
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 expectations and plans regarding
regulatory submissions for and the timing and conduct of clinical trials
of DEXTENZA™ for the treatment of post-surgical ocular inflammation and
pain, including our expectations regarding the NDA filed with
the FDA and the FDA’s response to the resubmitted NDA, DEXTENZA for the
treatment of allergic conjunctivitis, DEXTENZA for the treatment of
inflammatory dry eye disease and OTX-TP for the treatment of glaucoma
and ocular hypertension, the ongoing development of the Company’s
sustained release hydrogel technology, the potential utility of any of
the Company’s product candidates, potential commercialization of the
Company’s product candidates, the potential benefits and future
operation of the Company’s collaboration with Regeneron, 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 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 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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Source: Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc.
McClellan on behalf of Ocular Therapeutix
Steve Klass, 212-213-0006
Sandra Correa, 646-599-8637
Media and Business Group
Vice President of Marketing &