Ocular Therapeutix™ to Present Data at the American Society of Cataract and Refractive Surgery (ASCRS) Symposium
10 April 2018 - 6:30AM
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.:
- 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 PMWalter E. Washington Convention Center – Level 1, 144B
- 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 PMWalter E. Washington Convention
Center – Level 1, 143B
- 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
PMWalter 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 UseDEXTENZA 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
UseOTX-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 StatementsAny 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20180409006389/en/
InvestorsOcular TherapeutixDonald NotmanChief Financial
Officerdnotman@ocutx.comorWestwicke PartnersChris BrinzeyManaging
Directorchris.brinzey@westwicke.comorMediaOcular TherapeutixScott
CorningSenior Vice President, Commercialscorning@ocutx.com
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