BEDFORD, Mass.--(BUSINESS WIRE)--Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced data from its clinical and preclinical research will be highlighted in presentations at the combined American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators (ASCRS-ASOA) Symposium, April 13 -17, in Washington D.C. The presentations include clinical data for lead product candidate DEXTENZA™ (dexamethasone insert) 0.4 mg, for the treatment of pain following ophthalmic surgery, and pre-clinical data for product candidate OTX-TIC (travoprost implant), an intracameral injection for the reduction of intraocular pressure in patients with glaucoma and ocular hypertension.
“The presentations at ASCRS-ASOA highlight clinical data with DEXTENZA for treating patients following ophthalmic surgery and provide insight into the physician and patient experience with the product,” said Michael Goldstein, M.D., Chief Medical Officer of Ocular Therapeutix. “While our primary focus continues to be the resubmission of DEXTENZA in the second quarter of 2018, we are also excited about the progress of our pipeline product candidates including the pre-clinical data we are seeing with OTX-TIC for the treatment of glaucoma.”
Paper Presentations at ASCRS-ASOA, Washington, D.C.:
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Preclinical Assessment of OTX-TIC (travoprost) Biodegradable
Hydrogel Intracameral Depot for the Treatment of Glaucoma. Blizzard
C.
Sunday, April 15, 2018; 3:02 PM – 3:07 PM
Walter E. Washington Convention Center – Level 1, 144B
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Integrated Analysis of Efficacy and Safety of Dexamethasone Insert
(0.4 mg) for the Treatment of Ocular Pain and Inflammation after
Cataract Surgery. Berdahl J.
Monday, April 16, 2018; 1:41 PM – 1:46 PM
Walter E. Washington Convention Center – Level 1, 143B
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Evaluating the Physician and Patient Experience of a Dexamethasone
Insert (0.4 mg) in Patients Having Cataract Surgery. Noecker R.
Monday, April 16, 2018; 2:13 PM – 2:18 PM
Walter E. Washington Convention Center – Level 1, 143B
About Ocular Therapeutix, Inc.
Ocular Therapeutix,
Inc. is a biopharmaceutical company focused on the formulation,
development, and commercialization of innovative therapies for diseases
and conditions of the eye using its proprietary hydrogel-based
formulation technology. Ocular Therapeutix’s lead product candidate,
DEXTENZA™ (dexamethasone insert) 0.4 mg for intracanalicular use, has
completed Phase 3 clinical development for the treatment of ocular pain
and inflammation following ophthalmic surgery. OTX-TP (travoprost
insert) is in Phase 3 clinical development for the reduction of
intraocular pressure in patients with glaucoma and ocular hypertension.
The Company’s earlier stage assets include OTX-TIC, a sustained release
travoprost intracameral implant for the reduction of intraocular
pressure in patients with glaucoma and ocular hypertension, as well as
sustained release intravitreal implants for the treatment of retinal
diseases. These implants include the development of OTX-TKI, a tyrosine
kinase inhibitor (TKI), and, in collaboration with Regeneron, an
extended release protein-based anti-vascular endothelial growth factor
(VEGF) trap. Ocular Therapeutix's first product, ReSure® Sealant,
is FDA-approved to seal corneal incisions following cataract surgery.
About DEXTENZA™ (dexamethasone insert) 0.4 mg for
Intracanalicular Use
DEXTENZA is a corticosteroid
intracanalicular insert placed through the punctum, a natural opening in
the eye lid, into the canaliculus and is designed to deliver
dexamethasone to the ocular surface for up to 30 days
without preservatives. Following treatment, DEXTENZA is intended to
resorb and exit the nasolacrimal system without the need for removal.
About OTX-TIC (travoprost implant) for Intracameral Use
OTX-TIC
is designed to be a bioresorbable implant containing micronized
travoprost that is injected into the anterior chamber of the eye, with a
target duration of drug delivery of three to four months. Preclinical
studies in beagles have demonstrated sustained intraocular pressure
lowering and maintenance of drug levels in the aqueous humor.
Forward Looking Statements
Any statements in this press
release about future expectations, plans and prospects for the Company,
including the development and regulatory status of the Company’s product
candidates, such as the Company’s regulatory submissions for and the
timing and conduct of, or implications of results from, clinical trials
of DEXTENZA™ for the treatment of post-surgical ocular inflammation and
pain, including with respect to manufacturing deficiencies identified by
the Food and Drug Administration (FDA), the Company’s expectations
regarding resubmitting its NDA to the FDA and the prospects for
approvability of DEXTENZA for these indications, DEXTENZA for the
treatment of allergic conjunctivitis, DEXTENZA for the treatment of dry
eye disease and OTX-TP for the treatment of glaucoma and ocular
hypertension, the ongoing development of the Company’s sustained release
hydrogel depot technology, the potential utility of any of the Company’s
product candidates, potential commercialization of the Company’s product
candidates, the potential benefits and future operation of the
collaboration with Regeneron Pharmaceuticals, including any potential
future payments thereunder, the sufficiency of the Company’s cash
resources 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 or any product candidate that
receives regulatory approval, 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, the outcome of the Company’s ongoing legal proceedings 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 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.