New Data 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, presented yesterday new data from its most
recent Phase 3 study evaluating the safety and efficacy of DEXTENZA
(dexamethasone insert) 0.4 mg for the treatment of ocular pain and
inflammation following cataract surgery. The data were released at
the American Society of Cataract and Refractive Surgery Annual
Symposium (ASCRS) in Los Angeles, CA.
The U.S. Food and Drug Administration (FDA) has set a target
action date under the Prescription Drug User Fee Act (PDUFA) of
July 19, 2017 for a decision regarding the potential approval of
DEXTENZA for the treatment of ocular pain following ophthalmic
surgery.
Primary endpoints included absence of anterior chamber (AC)
cells (a sign of inflammation) at Day 14 and absence of pain at Day
8. Topical NSAIDs were not permitted. Both endpoints were
statistically superior to placebo, with more than 52% of patients
receiving DEXTENZA having no AC cells at Day 14 compared to 31.1%
of placebo subjects. Additionally, 79% of patients in the DEXTENZA
group reported no pain at Day 8 compared to 61.3% of the placebo
group. Statistical superiority of DEXTENZA was also noticed at Day
2 for the absence of ocular pain and Day 4 for the absence of AC
cells. There were no treatment-related serious adverse events
(SAEs) and DEXTENZA was well tolerated in all clinical trials. No
patients experienced any adverse events resulting in study
withdrawal.
A cross-sectional, qualitative survey, commissioned by Ocular
Therapeutix, evaluating patient experience of DEXTENZA among 25
patients from U.S. Phase 3 investigational clinical trials was also
presented at the ASCRS meeting. In the survey, 92% of patients
reported the highest level of overall satisfaction with the
product, and would recommend DEXTENZA to family and friends.
Further, 96% of patients reported the highest level of satisfaction
with regard to convenience. Additionally, 84% of patients reported
that they would be willing to pay more for DEXTENZA and would
request DEXTENZA again.
“DEXTENZA’s safety and efficacy profile, combined with a
positive patient experience, provide a strong foundation for
offering an alternative to current post-operative steroid eye
drops, which are associated with compliance issues,” said Amar
Sawhney, Ph.D., President, Chief Executive Officer and Chairman of
Ocular Therapeutix. “If approved, DEXTENZA may reduce the patient
burden of administering topical eye drops following ophthalmic
surgery by enabling physicians to control the entire course of
steroid therapy with a single administration.”
The Company also presented data on the importance of pain
assessment following ophthalmic surgery; preservatives in topical
ophthalmic medications used after ocular surgery; a literature
review on medical adherence for glaucoma; and the evaluation of a
Phase 3 clinical development program for OTX-TP, a sustained
release travoprost intracanalicular insert for the treatment of
glaucoma and ocular hypertension.
Phase 3 Study Design
This prospective, multicenter, 1:1 randomized, parallel-arm,
double-masked, vehicle-controlled study was designed to evaluate
the safety and efficacy of DEXTENZA for the treatment of ocular
inflammation and pain following cataract surgery. The study
enrolled 438 patients who were undergoing clear corneal cataract
surgery at 21 sites throughout the United States. Immediately
following surgery, patients were randomized to insertion of either
DEXTENZA or a placebo vehicle. Primary efficacy endpoints evaluated
the differences between the DEXTENZA treatment group and the
placebo group for the absence of anterior chamber cells at day 14
and absence of pain at day 8. Secondary efficacy endpoints included
absence of anterior chamber cells, absence of ocular flare, and
absence of ocular pain across relevant time points during the
30-day treatment period.
About DEXTENZA™ (dexamethasone insert) 0.4 mg 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.
Ocular Therapeutix resubmitted an NDA to
the FDA for DEXTENZA for the treatment of ocular pain
following ophthalmic surgery, for which the FDA has set a
PDUFA target action date of 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.
About Ocular Pain and Inflammation Following Ophthalmic
Surgery
Ocular 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) 0.4 mg for
intracanalicular use has completed Phase 3 clinical development for
the treatment of ocular pain and inflammation following 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 PDUFA target
action date of July 19, 2017. If approved, the Company
intends to 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 and
the potential impact of the re-inspection of manufacturing
operations, 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.
Disclaimer
Educational content of the ASCRS•ASOA Annual Symposium &
Congress is planned by its program committee, and ASCRS•ASOA does
not endorse, promote, approve, or recommend the use of any
products, devices, or services.
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version on businesswire.com: http://www.businesswire.com/news/home/20170508005509/en/
MediaMedical DynamicsSandra Correa, 646-599-8637Business
& Media Group
Directorscorrea@rxmedyn.comorInvestorsBurns McClellan on
behalf of Ocular TherapeutixSteve Klass,
212-213-0006sklass@burnsmc.comorOcular TherapeutixScott
CorningVice President of Marketing & Commercial
Operationsscorning@ocutx.com
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