Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company
focused on the development and commercialization of innovative therapies
for diseases and conditions of the eye, today announced top line results
for a Phase 2 clinical trial evaluating Sustained Release Dexamethasone
(OTX-DP) for treatment of allergic conjunctivitis.
The prospective, multicenter, randomized, double-masked statistically
powered study evaluated OTX-DP versus a placebo vehicle control at two
clinical sites in the United States. The Company used a modified
Conjunctival Allergen Challenge (CAC™) Model to accommodate for the
longer therapeutic effect of a one-time administered sustained release
drug product. The well controlled trial enrolled 68 patients with the
intent to treat for reactions to a variety of allergens over a 42-day
period. The primary effectiveness measure was ocular itching and
conjunctival redness at 14 days post-insertion.
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 FDA with other anti-allergic eye drops in the CAC
model. As compared to placebo, patients in the OTX-DP treatment group
achieved a mean difference of more than 0.5 units on a five point scale
at day 14 for both ocular itching and conjunctival redness. The trial
did not, however, achieve a mean difference of 1.0 unit at the majority
of time points for either ocular itching or conjunctival redness.
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
October 2014.
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 Amar Sawhney, Ph.D., President
and CEO of Ocular Therapeutix. “This Phase 2 trial provided valuable
insight into the advantages of utilizing a modified CAC model, which we
may incorporate into future trial design. We look forward to further
clinical evaluation of the product for the treatment of allergic
conjunctivitis. ”
Approximately 6.7 million anti-allergy prescriptions, generating almost
$800 million, were prescribed in the United States in 2013. “Eye allergy
sufferers experience itchy, watery, and red eyes which often keep them
from enjoying daily activities, and require daily administration of
medication to control the symptoms,” stated Francis Mah, M.D.,
Ophthalmologist at Scripps Health System in San Diego, CA, and Medical
Monitor for the study. “A sustained release corticosteroid punctum plug
is a novel delivery device which may help relieve the symptoms of more
chronic and/or severe allergic conjunctivitis while reducing the burden
on appropriate patients for daily therapy.”
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.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused on the
development and commercialization of innovative therapies for diseases
and conditions of the eye using its proprietary hydrogel platform
technology. Ocular Therapeutix’s lead product candidates are in Phase 3
clinical development for post-surgical ocular inflammation and pain, and
Phase 2 clinical development for glaucoma and allergic conjunctivitis.
The Company is also evaluating sustained-release injectable anti-VEGF
drug depots for back-of-the-eye diseases. Ocular Therapeutix’s first
product, ReSure® Sealant, is FDA-approved to seal corneal incisions
following cataract surgery.
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
Securities and Exchange Commission. In addition, the forward-looking
statements included in this press release represent the Company’s views
as of the date of this release. The Company anticipates that subsequent
events and developments will cause the Company’s views to change.
However, while the Company may elect to update these forward-looking
statements at some point in the future, the Company specifically
disclaims any obligation to do so. These forward-looking statements
should not be relied upon as representing the Company’s views as of any
date subsequent to the date of this release.
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