Ocular Therapeutix™ Reports Positive Topline Clinical Data for the First of Two Phase 3 Clinical Trials Evaluating OTX-DP for the Treatment of Post-Surgical Ocular Inflammation and Pain
-- Topline results of the second Phase 3 clinical trial expected by the end of March --
-- NDA submission anticipated in 2Q 2015 --
“This is an exciting day for
OTX-DP is a product candidate placed in the canaliculus and designed to
deliver dexamethasone to the ocular surface for approximately four
weeks. Following treatment, OTX-DP resorbs and exits the nasolacrimal
system without need for removal. In
About the OTX-DP Post-Surgical Inflammation and Pain Clinical Trials
Two prospective, multicenter, randomized, parallel-arm, double-masked, vehicle-controlled Phase 3 clinical trials, referred to as the Phase 3a and Phase 3b clinical trials, were completed with a total of 487 patients (247 patients in Phase 3a and 240 in Phase 3b) undergoing unilateral clear corneal cataract surgery. Patients were randomized 2:1 to receive either OTX-DP or a placebo vehicle control punctum plug without active drug. Both primary efficacy measures, differences in the proportion of patients in each treatment 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 measures 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.
Topline data from the Phase 3b clinical trial are expected to be announced by the end of March. If the Company obtains favorable aggregate results for both the Phase 3a and Phase 3b clinical trials, the Company expects to submit a New Drug Application (NDA) for OTX-DP for post-surgical ocular inflammation and pain in the second quarter of 2015. The Company believes that OTX-DP is the first sustained release drug-eluting corticosteroid punctum plug to enter and complete Phase 3 clinical trials.
About Post- Surgical Ocular Inflammation and Pain
Ocular inflammation and pain 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. Market Scope estimates approximately
5 million ocular surgeries will be performed in
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 3 clinical trials of OTX-DP for the
treatment of post-surgical ocular inflammation and pain, the potential
submission of an NDA for this indication, the potential utility of
OTX-DP for post-surgical ocular inflammation and pain, the timing and
conduct of the Company's Phase 2b clinical trial of OTX-TP for the
treatment of glaucoma and ocular hypertension and the Company’s Phase 3
clinical trials of OTX-DP for allergic conjunctivitis, 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 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
Ocular Therapeutix, Inc.
Chief Financial Officer
Burns McClellan on behalf of Ocular Therapeutix
Kimberly Minarovich, 212-213-0006
Vice President of Sales and Marketing