Ocular Therapeutix’s glaucoma treatment fails to meet primary endpoint in P3 trial, for gets statistically significant reduction of intraocular pressure versus placebo

May 20, 2019 Off By BusinessWire

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

BEDFORD, Mass.–(BUSINESS WIRE)–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	p-value	OTX-TP	Vehicle	p-value	OTX-TP	Vehicle	p-value
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 Statements
Any 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.