OTX-TP failed to meet primary endpoint but
achieved statistically significant reduction of intraocular
pressure versus placebo at eight of the nine pre-specified time
points
The Company plans to discuss the data from the
clinical trial with the FDA and determine next steps
Ocular Therapeutix™, Inc. (NASDAQ: OCUL), a biopharmaceutical
company focused on the formulation, development, and
commercialization of innovative therapies for diseases and
conditions of the eye, today announced topline results from the
first pivotal Phase 3 clinical trial of OTX-TP, an intracanalicular
insert that delivers a preservative-free formulation of the drug
travoprost for the reduction of intraocular pressure (IOP) in
patients with primary open-angle glaucoma or ocular hypertension.
OTX-TP is designed to lower IOP for up to 90 days and to address
the poor adherence associated with chronic, daily eye drop
regimens, the current standard of care.
The Phase 3 randomized, double blind, placebo-controlled
clinical trial was conducted across more than 50 sites and enrolled
554 subjects with open-angle glaucoma or ocular hypertension in the
full analysis set (FAS) population. The trial’s primary efficacy
endpoint was to demonstrate a statistically superior mean reduction
of IOP from baseline for OTX-TP treated subjects compared with
placebo insert treated subjects at nine different time points,
three diurnal time points (8 AM, 10 AM, and 4 PM) at each of 2, 6,
and 12 weeks following insertion. Topline results show that the
trial did not achieve its primary endpoint of statistically
significant superiority in mean reduction of IOP compared with
placebo at all nine time points. OTX-TP treated subjects did have a
greater reduction in IOP from baseline relative to placebo insert
at all nine time points, and these differences were statistically
significant (p value < 0.05) for eight of the nine time points
(Table 1). The reductions from baseline for OTX-TP treated subjects
in this trial ranged from 3.27-5.72 millimeters of mercury (mm Hg)
across the nine time points with higher levels of intraocular
pressure reduction seen at the earlier time points in this
trial.
Table 1: Reduction in Intraocular Pressure (Change
from Baseline) Diurnal Time
points 2 Week 6 Week 12 Week mm Hg
p-value mm Hg p-value mm Hg
p-value OTX-TP Vehicle OTX-TP
Vehicle OTX-TP Vehicle 8:00 AM -5.72 -3.88
<.0001 -4.81 -4.01 0.0181 -3.91 -3.52 0.2521 10:00 AM -4.92
-3.16 <.0001 -4.03 -3.23 0.0077 -3.34 -2.63 0.0234 4:00 PM -5.22
-3.18 <.0001 -4.16 -3.14 0.0004 -3.27 -2.60 0.0310
FAS
Population (OTX-TP=343 subjects, Vehicle=211 subjects) Least
Squares (LS) Means
OTX-TP was generally well tolerated and no ocular serious
adverse events were observed. The most common ocular adverse events
seen in the study eye were dacryocanaliculitis (approximately 7% in
OTX-TP vs. 3% in placebo) and lacrimal structure disorder
(approximately 6% in OTX-TP vs. 4% in placebo).
“We are encouraged by the results of this trial which shows
OTX-TP’s ability to lower IOP out to 12 weeks with a single insert
using this novel dosage form,” stated Michael Goldstein, MD, Chief
Medical Officer. “In our opinion, this product candidate represents
a new opportunity for treating glaucoma patients that has the
potential to address one of the biggest issues we deal with in
clinical practice, the challenges patients have in taking eye
drops. We will continue to review the data from the trial, and we
look forward to meeting with the FDA to discuss these results
before determining the next steps in our clinical development
plans.”
About Ocular Therapeutix, Inc.Ocular Therapeutix,
Inc. is a biopharmaceutical company focused on the formulation,
development, and commercialization of innovative therapies for
diseases and conditions of the eye using its proprietary
bioresorbable hydrogel-based formulation technology. Ocular
Therapeutix’s first commercial drug product, DEXTENZA®, is
FDA-approved for the treatment of ocular pain following ophthalmic
surgery. OTX-TP (intracanalicular travoprost insert) is an
intracanalicular insert in Phase 3 clinical development for the
reduction of intraocular pressure in patients with primary
open-angle glaucoma and ocular hypertension. The Company’s earlier
stage assets include OTX-TIC, an extended-delivery intracameral
travoprost implant for the reduction of intraocular pressure in
patients with glaucoma and ocular hypertension, as well as
sustained release intravitreal implants for the treatment of
retinal diseases. These intravitreal implants include OTX-TKI,
containing a tyrosine kinase inhibitor (TKI), and, in collaboration
with Regeneron, OTX-IVT, an extended-delivery protein-based
anti-vascular endothelial growth factor (VEGF) trap. 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 commercialization of DEXTENZA®, ReSure
Sealant, or any of the Company’s product candidates, including the
anticipated commercial launch of, and receipt of reimbursement
codes for, DEXTENZA; the development and regulatory status of the
Company’s product candidates, such as the Company’s regulatory
submissions for and the timing and conduct of, or implications of
results from, clinical trials of DEXTENZA for the treatment of
post-surgical ocular inflammation and the prospects for the
approvability of, and discussions with regulatory authorities
regarding, DEXTENZA for post-surgical ocular inflammation or any
other indications, OTX-TP for the treatment of primary open-angle
glaucoma and ocular hypertension, OTX-TIC for the treatment of
primary open-angle glaucoma and ocular hypertension, OTX-TKI for
the treatment of retinal diseases including wet AMD, and OTX-IVT as
an extended-delivery formulation of the VEGF trap aflibercept for
the treatment of retinal diseases including wet AMD; the ongoing
development of the Company’s extended-delivery hydrogel depot
technology; the potential utility of any of the Company’s product
candidates; the potential benefits and future operation of the
collaboration with Regeneron Pharmaceuticals, 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 DEXTENZA, ReSure Sealant or any product candidate
that receives regulatory approval, including the conduct of
post-approval studies, the ability to retain regulatory approval of
DEXTENZA, ReSure Sealant or any product candidate that receives
regulatory approval, the ability to obtain reimbursement codes for
DEXTENZA, the initiation, timing 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, the Company’s existing indebtedness,
the ability of the Company’s creditors to accelerate the maturity
of such indebtedness upon the occurrence of certain events of
default, the outcome of the Company’s ongoing legal proceedings 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 except as required
by law. 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: https://www.businesswire.com/news/home/20190520005742/en/
InvestorsOcular TherapeutixDonald NotmanChief Financial
Officerdnotman@ocutx.comorWestwicke, an ICR CompanyChris
BrinzeyManaging
Directorchris.brinzey@westwicke.comMediaOcular
TherapeutixScott CorningSenior Vice President,
Commercialscorning@ocutx.com
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