New Clinical Data to Be Presented Evaluating
the Use of DEXTENZA Following Cataract Surgery
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 new data to be presented
from its most recent Phase 3 study evaluating the efficacy and
safety of DEXTENZA™ (dexamethasone insert, 0.4mg) for
intracanalicular use, for the treatment of ocular pain and
inflammation following cataract surgery, at the upcoming American
Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting,
being held May 5-9, in Los Angeles, Calif.
The U.S. Food and Drug Administration (FDA) has assigned a
target action date under the Prescription Drug User Fee Act (PDUFA)
of July 19, 2017 for the potential approval of DEXTENZA™ for the
treatment of ocular pain following ophthalmic surgery.
“We believe that DEXTENZA, which utilizes Ocular’s proprietary
hydrogel platform technology to provide sustained release of
steroid therapy for up to 30 days, has the opportunity to offer an
attractive alternative to the current post-operative standard of
care for those recovering from ophthalmic surgery,”
said Jonathan H. Talamo, M.D., Chief Medical Officer
of Ocular Therapeutix. “The new data to be presented highlight
the efficacy and safety profile of DEXTENZA for the treatment of
ocular pain and inflammation following cataract surgery, and
underscore the Company’s efforts to help address the needs of
patients currently using steroid eye drops, which are associated
with compliance issues.”
Additional presentations will be made regarding recent positive
results of a patient experience study of DEXTENZA as well as the
importance of the assessment of pain. The Company will also present
information surrounding its ongoing Phase 3 clinical development
program with OTX-TP (travoprost insert) for the treatment of
glaucoma and ocular hypertension.
Poster Presentations:
- Safety and Efficacy of an Extended
Release Dexamethasone Insert for Treatment of Ocular Inflammation
and Pain after Surgery: Phase 3 Study - May 7th from 2:16 PM - 2:21
PM at the L.A. Convention Center - Meeting Room Level, 409A
- Evaluating the Patient Experience After
Implantation of a 0.4 mg Sustained Release Dexamethasone
Intracanalicular Insert - May 7th from 2:11 PM - 2:16 PM at the
L.A. Convention Center - Meeting Room Level, 409AB
- Preservatives in Topical Ophthalmic
Medications Used After Ocular Surgery - May 7th from 1:56 PM - 2:01
PM at the L.A. Convention Center - Meeting Room Level, 409AB
- Adherence to Medical Therapy for
Glaucoma: Review of the Literature - May 7th from 8:43 AM - 8:48 AM
at the L.A. Convention Center - Meeting Room Level, 410
E-poster Presentations:
- The Importance of Pain Assessment
Following Ophthalmic Surgery
- A Phase 3 Clinical Development Program
for OTX-TP, a Novel Sustained Release Travoprost Intracanalicular
Depot, for the Treatment of Patients with Open Angle Glaucoma or
Ocular Hypertension
About DEXTENZA™ (dexamethasone insert, 0.4mg) for
Intracanalicular Use
DEXTENZA 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 a
supplement to its NDA for DEXTENZA to broaden its label to include
a post-surgical ocular 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
Ocular pain and inflammation are common side effects following
ophthalmic surgery. Physicians prescribe anti-inflammatory drugs,
such as 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, 0.4 mg)
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
following ophthalmic surgery and has established a target PDUFA
date of July 19, 2017. If approved, the Company will
submit a supplement to its NDA for ocular inflammation. 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 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 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, 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170424005667/en/
Media:Medical DynamicsSandra Correa,
646-599-8637Media and Business Group
Directorscorrea@rxmedyn.comorOcular
Therapeutix, Inc.Scott CorningVice President of
Marketing & Commercial
Operationsscorning@ocutx.comorInvestors:Burns
McClellan on behalf of Ocular TherapeutixSteve Klass,
212-213-0006sklass@burnsmc.com
Ocular Therapeutix (NASDAQ:OCUL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Ocular Therapeutix (NASDAQ:OCUL)
Historical Stock Chart
From Apr 2023 to Apr 2024