Statistically significant secondary endpoint of
absence of ocular flare confirms further evidence of reduction of
inflammation
Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical
company focused on the development and commercialization of
innovative therapies for diseases and conditions of the eye, today
announced additional positive secondary endpoint results from its
most recent successful phase 3 clinical trial of DEXTENZA™
(dexamethasone insert) 0.4 mg, for the treatment of post-surgical
ocular inflammation and pain. DEXTENZA is a product candidate
administered by a physician as a bioresorbable intracanalicular
insert and designed to release drug to the ocular surface for up to
30 days.
The secondary endpoint, the absence of anterior chamber (AC)
flare, an indicator of inflammation, was statistically superior to
placebo at all measured time points. Approximately 46% of patients
in the DEXTENZA treatment group were shown to have an absence of AC
flare at day 4 after insertion, which Ocular believes provides
further support of the early onset anti-inflammatory effect of
DEXTENZA. Additional secondary efficacy endpoints included
differences in the absence of AC cells and ocular pain on days 2,
4, 14, and 30 after insertion. As previously reported, all of these
secondary endpoints were met with statistical significance with the
exception of the endpoint for the absence of AC cells at day 2.
As also previously announced, DEXTENZA successfully met the
trial’s two primary efficacy endpoints, absence of ocular pain on
day 8 and absence of ocular inflammation on day 14 when compared to
placebo. In this Phase 3 clinical trial, for which the complete
safety assessment will be available in the first quarter of 2017,
no treatment-related serious adverse events were observed. DEXTENZA
has exhibited a favorable safety profile and has been well
tolerated in all clinical trials, regardless of indication.
“The positive results for the secondary endpoint of absence of
ocular flare build upon the successful topline results from this
trial which we announced last month,” said Jonathan H. Talamo,
M.D., Chief Medical Officer of Ocular Therapeutix. “Ocular flare
occurs when the protein content of the aqueous humor increases due
to intraocular inflammation, so the fact that we are seeing a
statistically significant decrease in the absence of flare across
all time points further supports the efficacy profile of
DEXTENZA.”
Summary of Efficacy Results from Third Phase 3 Trial of
DEXTENZA for the Treatment of Post-Surgical Ocular Inflammation and
Pain
Visit Efficacy Endpoint
Day 2* Day 4 Day 8
Day 14 Day 30 Proportion of patients with
an absence of AC cells
DEXTENZA Group(P Value)
1.9%*** 14.1%
(P<0.05)
29.1%
(P<0.0001)
52.1%
**
(P<0.0001)
81.0%
(P<0.0001)
Placebo Group 2.3% 7.7% 11.7%
31.2% 63.3%
Proportion of patients with an absence of
ocular pain
DEXTENZA Group(P Value)
73.0%
(P<0.0001)
76.5%
(P<0.0001)
79.3%
**
(P<0.0001)
84.2%
(P<0.0001)
89.1%
(P<0.05)
Placebo Group
56.8% 61.1% 61.3% 70.1% 80.0%
Proportion of patients with an absence of AC flare
DEXTENZA Group(P Value)
28.8%
(P<0.05)
46.0%
(P<0.05)
58.2%
(P<0.0001)
73.5%
(P<0.0001)
90.0%
(P<0.05)
Placebo Group 19.8% 29.4% 36.9%
49.3% 79.5%
*Day following insertion**Primary endpoints of trial; both
primary efficacy endpoints were achieved*** Did not achieve
statistical significance; all other efficacy endpoints were
achieved
Phase 3 Study DesignThis 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 ophthalmic
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.
This was the third Phase 3 clinical trial that the Company has
conducted with DEXTENZA for the treatment of ocular inflammation
and pain following ophthalmic surgery. Independent of the results
of this third trial and based on the results from the first two
Phase 3 clinical trials, Ocular Therapeutix plans to resubmit a New
Drug Application (NDA) to the FDA for DEXTENZA for the treatment of
ocular pain occurring after ophthalmic surgery early in the first
quarter of 2017. The purpose of conducting this third Phase 3
clinical trial was to support the Company’s label expansion
strategy for DEXTENZA. Accordingly, subject to the approval of the
NDA for post-surgical ocular pain by the FDA, Ocular Therapeutix
intends to submit a supplemental NDA for DEXTENZA to broaden its
label to include an indication for post-surgical inflammation.
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. Approximately 3.8
million cataract cases were performed in the United States in
2015.
About Ocular Therapeutix, Inc.Ocular Therapeutix, Inc.
(NASDAQ: OCUL) is a biopharmaceutical company focused on the
development and commercialization of innovative therapies for
diseases and conditions of the eye using its proprietary hydrogel
platform technology. Ocular Therapeutix plans to resubmit an NDA in
the first quarter of 2017 for post-surgical pain for its lead
product candidate, DEXTENZA™ (dexamethasone insert), which has
completed Phase 3 clinical development for post-surgical ocular
inflammation and pain. Subject to the approval of the NDA for
post-surgical ocular pain, Ocular Therapeutix intends to submit a
supplemental NDA for DEXTENZA to broaden its label to include an
indication for post-surgical inflammation. DEXTENZA is also in
Phase 3 clinical development for allergic conjunctivitis. 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.
For additional information about the Company, please visit
www.ocutx.com.
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
resubmission of the 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 depot 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 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/20170104005445/en/
InvestorsOcular Therapeutix, Inc.Brad SmithChief
Financial Officerbsmith@ocutx.comorBurns McClellan on behalf of
Ocular TherapeutixSteve Klass,
212-213-0006sklass@burnsmc.comorMediaMedical DynamicsCynthia
Sutherland, 646-599-8635Media Group
Directorcsutherland@rxmedyn.com
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