Press Release
Ocular Therapeutix™ Submits New Drug Application to U.S. Food and Drug Administration for DEXTENZA® for the Treatment of Post-Surgical Ocular Pain
Third Phase 3 Clinical Trial for Post-Surgical Ocular Inflammation
and Pain Expected to Be Initiated in
“This represents Ocular Therapeutix’s first NDA filing with the
Based on the results of the Company’s two completed Phase 3 clinical
trials and following a Pre-NDA Clinical meeting with the
About DEXTENZA
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 is designed to deliver
dexamethasone to the ocular surface for four weeks. Following treatment,
DEXTENZA resorbs and exits the nasolacrimal system without need for
removal. Earlier this year,
Two prospective, multicenter, randomized, parallel-arm, double-masked, vehicle-controlled Phase 3 clinical trials were completed with a total of 487 patients undergoing unilateral clear corneal cataract surgery in the first half of 2015. Patients were randomized 2:1 to receive either DEXTENZA or a placebo vehicle control punctum plug without active drug. Both primary efficacy endpoints, differences in the proportion of patients in the DEXTENZA treatment group compared with the placebo group with absence of cells in the anterior chamber of the study eye, as measured using slit lamp examination, at day 14 and absence of pain, as graded by a patient-reported score of zero on a scale from zero to ten, at day 8, were recorded at each study visit. Secondary efficacy endpoints were absence of flare in the anterior chamber of the study eye at each evaluation date and absence of inflammatory cells in the anterior chamber of the study eye and absence of pain in the study eye at each evaluation date other than the day used for the primary efficacy measure.
About Post-Surgical Ocular Inflammation and Pain
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 DEXTENZA® 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/20150928005347/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:
Scott
Corning
Vice President of Sales and Marketing
scorning@ocutx.com