BEDFORD, Mass.--(BUSINESS WIRE)--Oct. 8, 2014--
Ocular Therapeutix, Inc. (NASDAQ: OCUL) announced today completion of
enrollment for its two Phase 3 clinical trials evaluating Sustained
Release Dexamethasone (OTX-DP) for treatment of ocular inflammation and
pain following cataract surgery. OTX-DP is a one-time administration
product candidate placed in the canaliculus and designed to deliver
dexamethasone to the ocular surface for approximately four weeks.
Following treatment, OTX-DP resorbs and exits the nasolacrimal system
without the need for removal.
The two prospective, multicenter, randomized, parallel-arm,
double-masked, vehicle-controlled studies are evaluating 486 patients at
32 sites throughout the United States. Following surgery, patients were
randomized to receive either OTX-DP or a placebo vehicle punctum plug
without active drug. Primary efficacy endpoints for the studies are the
absence of inflammatory cells in the anterior chamber of the eye at Day
14, and reduction of pain at Day 8.
“Completion of enrollment for OTX-DP is an extraordinary milestone for
our company, not only as our first Phase 3 clinical trials for a
sustained release pharmaceutical, but also the first Phase 3 trials ever
to be completed for a sustained release, drug delivery punctum plug,”
stated Amar Sawhney, Ph.D., President and CEO of Ocular Therapeutix,
Inc. “We look forward to submitting results to the FDA in 2015.”
Topical corticosteroids are typically prescribed to treat ocular
inflammation and pain following ophthalmic surgery. However, topical
steroid regimens can be complex, which can lead to lower levels of
compliance and thus may adversely affect outcomes. Conversely, chronic
administration of topical corticosteroids can lead to spikes in
intraocular pressure, which may induce glaucoma. A physician
administered, single-dose corticosteroid puts compliance in the hands of
physicians, and may improve issues of patient non-compliance with dosing
regimens.
“OTX-DP is easily inserted, and can be monitored by the physician during
the post-operative period,” stated Thomas R. Walters, M.D., Principal
Investigator at Texan Eye in Austin, Texas. “In a previously completed
Phase 2 clinical trial, treatment with OTX-DP significantly relieved
pain at Day 8, as reported by the patient, and inflammation at Day 14,
as measured by absence of inflammatory cells in the anterior chamber of
the eye, compared to vehicle control, and patients were comfortable with
the plug.”
About Sustained Release Dexamethasone
Sustained Release Dexamethasone (OTX-DP) is a drug product candidate
that is placed within the canaliculus and delivers the corticosteroid
dexamethasone to the ocular surface for approximately four weeks. The
drug release is tailored such that a low-dose is sustained throughout
the treatment period, and incorporates a natural taper to mimic a
topical post-operative regimen.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. 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’s lead product candidates are in Phase 3
clinical development for post-surgical ocular inflammation and pain, and
Phase 2 clinical development for glaucoma and allergic conjunctivitis.
The Company is also evaluating sustained-release injectable anti-VEGF
drug 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 statements about the
development of the Company’s product candidates, such as the timing and
conduct of the Company’s Phase 3 clinical trials of OTX-DP for the
treatment of ocular inflammation and pain following cataract surgery ,
the expected timing to submit results from such trials to the FDA, the
advancement of other product candidates in the Company's pipeline 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, the initiation and conduct
of clinical trials, availability of data from clinical trials and
expectations for regulatory 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 Report on Form 10-Q for the quarter ended June 30,
2014. 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.
Source: Ocular Therapeutix, Inc.
Investors:
Ocular Therapeutix, Inc.
Brad Smith
Chief
Financial Officer
bsmith@ocutx.com
or
Burns
McClellan on behalf of Ocular Therapeutix
Kimberly Minarovich,
212-213-0006
kminarovich@burnsmc.com
or
Media:
Scott
Corning
Vice President of Sales and Marketing
scorning@ocutx.com
