Press Release
Ocular Therapeutix™ Begins Enrollment in Third Phase 3 Clinical Trial for DEXTENZA™ for the Treatment of Post-Surgical Ocular Inflammation and Pain
Based on the results of the Company’s two previously completed Phase 3
clinical trials and following a Pre-NDA Clinical meeting with the
“This is an important step for Ocular as we continue to execute on our
label expansion strategy for DEXTENZA and we look forward to offering
patients this innovative alternative to steroid eye drop therapy,” said
This prospective, multicenter, randomized, parallel-arm, double-masked,
vehicle-controlled study is enrolling 436 patients undergoing clear
corneal cataract surgery at 20 sites throughout
- 1:1 patient randomization of treatment and placebo groups instead of a 2:1 randomization;
- Exclusion of patients who are being treated with high dosage levels of oral nonsteroidal anti-inflammatory drugs, or NSAIDs; and
- Improvement of the training and guidance to the on-site clinical investigators regarding adherence to study protocols, including the appropriate use of rescue medications.
The Company anticipates that top-line efficacy results from this trial will be available in late 2016.
About DEXTENZATM
DEXTENZA (sustained release dexamethasone) 0.4 mg Intracanalicular Depot is a product candidate placed through the punctum, a natural opening in the eyelid, into the canaliculus and delivers dexamethasone to the ocular surface for four weeks. Following treatment, DEXTENZA resorbs and exits the nasolacrimal system without need for removal. To capitalize on the broader opportunity for the sustained delivery of corticosteroids to the front of the eye, the Company is pursuing multiple indications for DEXTENZA.
Earlier this year,
About Ocular Inflammation and Pain Following Ophthalmic Surgery
Ocular pain and inflammation are common side effects following
ophthalmic surgery. Physicians prescribe anti-inflammatory drugs, such
as corticosteroids, as the standard of care. If left untreated,
inflammation of the eye may result in further ocular complications,
including scarring and vision loss. Approximately 5.3 million ocular
surgeries were performed in
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 Company’s
plans for regulatory submissions and the design, initiation and conduct
of a third clinical trial of DEXTENZATM for
post-surgical inflammation and pain, the ongoing development of the
Company’s sustained release hydrogel depot technology, the timing and
conduct of the Company’s Phase 2b clinical trial of OTX-TP for the
treatment of glaucoma and ocular hypertension, the Company’s Phase 3
clinical trials of DEXTENZA for allergic conjunctivitis and the
Company’s Phase 2 clinical trial of OTX-DP for the treatment of
inflammatory dry eye disease, the advancement of the Company's other
product candidates 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/20151014006492/en/
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:
Ocular
Therapeutix, Inc.
Scott Corning
Vice President of Sales and
Marketing
scorning@ocutx.com