Press Release
Ocular Therapeutix™ Enrolls First Patients in Phase 2b Clinical Trial for Sustained Release Travoprost for the Treatment of Glaucoma and Ocular Hypertension
The prospective, multicenter, randomized, double-masked, parallel-arm, active controlled study is designed to evaluate 80 patients at 10 clinical sites for the safety and efficacy of the OTX-TP as compared to timolol. Study efficacy endpoints include difference in the mean intraocular pressure change between the treatment groups from baseline at multiple timepoints throughout the study.
Previous pilot and Phase 2a clinical trials evaluating OTX-TP showed
robust reductions in intraocular pressure for up to three months,
similar to results found with twice-daily timolol dosing. No serious
adverse events occurred, including no increases in hyperemia, and
patients were comfortable with use of the plug overall. “It is our hope
that OTX-TP will have a significant impact in helping to fight one of
the leading causes of blindness in the world,” stated
Glaucoma and ocular hypertension are chronic, sight-threatening diseases
caused by elevated intraocular pressure, which affects approximately 2.7
million people in
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 approximately 90 days. The drug release is tailored such that a continuous, low-dose is sustained throughout the treatment period. A visualization aid is incorporated into the plug so that both the doctor and the patient may monitor drug presence through the entire 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 timing and
conduct of the Company’s Phase 2b clinical trial of OTX-TP for the
treatment of glaucoma and ocular hypertension , the potential utility
and convenience of OTX-TP, 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 most recent Quarterly Report on Form 10-Q on file with the
1 Vision problems in the U.S.: Prevalence of adult vision
impairment and age-related eye disease in America. Prevent Blindness in
2
Source:
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