BEDFORD, Mass.--(BUSINESS WIRE)--May 3, 2018--
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 the treatment of the first patient in a Phase 1, open-label,
proof-of-concept clinical trial being conducted in the United States for
OTX-TIC, a bioresorbable travoprost implant delivered via an
intracameral injection for the reduction of intraocular pressure in
patients with glaucoma and ocular hypertension.
“One of the biggest unmet needs in ophthalmology, and in glaucoma in
particular, is solving the problem of non-compliance,” said Michael
Goldstein, M.D., Chief Medical Officer of Ocular Therapeutix. “OTX-TIC
is designed to directly address compliance issues by delivering
travoprost over the course of several months with a single implant. We
are excited to initiate this U.S. clinical trial in patients with
glaucoma and ocular hypertension as we continue to advance our pipeline.”
In preclinical studies, OTX-TIC has demonstrated an acceptable safety
profile and a marked reduction in intraocular pressure. OTX-TIC features
a sustained release profile and is designed to support dosing with a
duration of four to six months in a single administration.
This U.S.-based, Phase 1, multi-center, open-label, prospective,
proof-of-concept clinical trial will evaluate the safety, efficacy,
durability, and tolerability of OTX-TIC in patients with primary
open-angle glaucoma or ocular hypertension.
About OTX-TIC (travoprost implant) for Intracameral Use
OTX-TIC
is a bioresorbable intracameral implant containing micronized travoprost
that is injected into the anterior chamber of the eye and is intended
for patients with glaucoma with a target duration of drug delivery of
four to six months. Preclinical studies in beagles have demonstrated
maintenance of drug levels in the aqueous humor and a sustained lowering
of intraocular pressure.
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 hydrogel-based formulation
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. OTX-TP (travoprost insert) is
in Phase 3 clinical development for the reduction of intraocular
pressure in patients with glaucoma and ocular hypertension. The
Company’s earlier stage assets include OTX-TIC, a sustained release
travoprost intracameral implant for the reduction of intraocular
pressure in patients with glaucoma and ocular hypertension and two
sustained release intravitreal implants for the treatment of retinal
diseases. The intravitreal implants include OTX-TKI, a tyrosine kinase
inhibitor (TKI) being developed for the treatment of wet age-related
macular degeneration, and OTX-IVT, a sustained release formulation of
the anti-vascular endothelial growth factor (VEGF) aflibercept, being
developed in collaboration with Regeneron. 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 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 pain and
inflammation, including with respect to manufacturing deficiencies
identified by the Food and Drug Administration (FDA), the Company’s
expectations regarding resubmitting its NDA to the FDA and the prospects
for approvability of DEXTENZA for these indications, the Company’s
clinical development of DEXTENZA for the treatment of allergic
conjunctivitis, DEXTENZA for the treatment of dry eye disease, OTX-TP
for the treatment of mild to moderate glaucoma and ocular hypertension,
OTX-TIC for the treatment of moderate to severe glaucoma and ocular
hypertension, and OTX-TKI for the treatment of wet age-related macular
degeneration, 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, 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 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, 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.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180503005805/en/
Source: Ocular Therapeutix, Inc.
Investors:
Ocular Therapeutix
Donald Notman
Chief
Financial Officer
dnotman@ocutx.com
or
Westwicke
Partners
Chris Brinzey
Managing Director
chris.brinzey@westwicke.com
or
Media:
Ocular
Therapeutix
Scott Corning
Senior Vice President, Commercial
scorning@ocutx.com
