Press Release
Ocular Therapeutix™ Announces Phase 3 Clinical Development Plan for OTX-TP, an Innovative Therapy for Glaucoma and Ocular Hypertension
Pivotal Phase 3 Trials to use Placebo as Comparator
First Phase 3 clinical trial expected to commence in third quarter of 2016
The planned trial design for the two Phase 3 clinical trials includes an
OTX-TP treatment arm and a placebo-controlled comparator arm that would
use a non-drug eluting hydrogel-based intracanalicular depot. The
Company does not expect that a timolol comparator or validation arm will
be required in the study design and does not expect that eye drops,
placebo or active, will be administered in either arm. The Company
expects that the
“We are pleased with the outcome of our recent meeting with the
About Glaucoma and Ocular Hypertension
Glaucoma and ocular hypertension are chronic, sight-threatening diseases
in which elevated levels of intraocular pressure are associated with
damage to the optic nerve, which may result in irreversible vision loss.
Glaucoma is the second leading cause of blindness in the world. Ocular
hypertension is characterized by elevated levels of intraocular pressure
without any optic nerve damage. Patients with ocular hypertension are at
high risk of developing glaucoma. In the U.S. alone 2.7 million people
suffer from glaucoma. According to
About Sustained Release Travoprost
Sustained Release Travoprost (OTX-TP) is a preservative-free drug product candidate that resides within the canaliculus and delivers the prostaglandin analog travoprost to the ocular surface for up to 90 days. The drug depot is designed to deliver a continuous steady release throughout the treatment period. A fluorescent visualization aid is formulated within the product to enable both the physician and the patient to monitor drug presence throughout the course of therapy.
About
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 ongoing
development and potential utility of OTX-TP for glaucoma and ocular
hypertension and the timing, design and conduct of the planned Phase 3
clinical trials of OTX-TP, the availability of data from clinical
trials, the Company’s plans for regulatory submissions and the
advancement of the Company's other product candidates, the potential for
the Company’s sustained release hydrogel depot technology 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 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
View source version on businesswire.com: http://www.businesswire.com/news/home/20160216006679/en/
Source:
Investors
Ocular Therapeutix, Inc.
Brad Smith
Chief
Financial Officer
bsmith@ocutx.com
or
Burns
McClellan on behalf of Ocular Therapeutix
Steve Klass, 212-213-0006
sklass@burnsmc.com
or
Media
Ocular
Therapeutix, Inc.
Scott Corning
Vice President of Sales and
Marketing
scorning@ocutx.com