Press Release
Ocular Therapeutix™ Announces Top-Line Results from Phase 2 Sustained Release Dexamethasone Trial for Allergic Conjunctivitis
OTX-DP Demonstrated Statistically Significant Therapeutic Effect for Ocular Itching and Conjunctival Redness over Six Weeks with a Single Dose
The prospective, multicenter, randomized, double-masked statistically
powered study evaluated OTX-DP versus a placebo vehicle control at two
clinical sites in
OTX-DP treated subjects presented statistically significant lower ocular
itching and conjunctival redness scores than the placebo group at all
three time points measured on Days 14, 28, and 42 after insertion.
OTX-DP met one of the two criteria for treatment success previously
established by the
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. We believe OTX-DP is the first
sustained release corticosteroid punctum plug to be evaluated in
clinical trials for the treatment of allergic conjunctivitis. OTX-DP is
also in Phase 3 clinical trials for the treatment of post-operative
inflammation and pain, having completed enrollment for two studies in
Although effective for treatment of allergic conjunctivitis, topical
corticosteroids are often limited in use due to potential side effects
such as increased intraocular pressure. “A low-dose, sustained release
corticosteroid may alleviate the symptoms of allergic conjunctivitis
without unwanted side effects,” stated
Approximately 6.7 million anti-allergy prescriptions, generating almost
About Sustained Release Dexamethasone
Sustained Release Dexamethasone (OTX-DP) is a drug product candidate that is placed within the canaliculus and is designed to deliver the corticosteroid dexamethasone to the ocular surface for approximately four weeks. The drug release is tailored such that a low-dose is sustained throughout the treatment period.
About the Modified Conjunctival Allergen Challenge
The modified CAC model used in the recently completed study has been developed to study the interactions between the early and late phases of the allergic response in the eye, and to evaluate the effects of pharmaceutical intervention. The modified CAC model utilizes four challenges conducted over a 2-day interval to evaluate the effectiveness of a test agent to prevent an acute ocular allergic reaction, as well as evaluate the test agent’s ability to prevent an acute ocular allergic reaction in the presence of subclinical late phase inflammation.
About Ocular Therapeutix, Inc.
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, the potential utility
of OTX-DP for the treatment of allergic conjunctivitis, the design and
conduct of future trials of OTX-DP, 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
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