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 cataract surgery.
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 ophthalmic surgery.
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 ophthalmic surgery.”
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 inflammation indication.
About DEXTENZA™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
SurgeryOcular 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 2016.
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
surgery.
Forward Looking StatementsAny 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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version on businesswire.com: http://www.businesswire.com/news/home/20170315005218/en/
InvestorsOcular Therapeutix, Inc.Brad SmithChief
Financial Officerbsmith@ocutx.comorBurns McClellan on behalf of
Ocular TherapeutixSteve Klass,
212-213-0006sklass@burnsmc.comorMediaMedical DynamicsSandra
Correa, 646-599-8637Media and Business Group
Directorscorrea@rxmedyn.comorOcular Therapeutix, Inc.Scott
CorningVice President of Marketing & Commercial
Operationsscorning@ocutx.com
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