BEDFORD, Mass.--(BUSINESS WIRE)--Apr. 27, 2018--
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 that data from its preclinical research will be highlighted in
presentations and posters at the Association for Research in Vision and
Ophthalmology (ARVO) Annual Meeting, April 29 – May 3, in Honolulu, HI.
The presentations include preclinical data for product candidates
OTX-TIC (travoprost implant), an intracameral injection for the
reduction of intraocular pressure in patients with glaucoma and ocular
hypertension and OTX-TKI (tyrosine kinase inhibitor implant), an
intravitreal injection for the treatment of retinal neovascular diseases.
“The data presented at ARVO highlight the promise of our hydrogel-based
technology platform as our OTX-TIC and OTX-TKI product candidates enter
clinical development. Our sustained release therapies are intended to
address unmet needs across several areas in ophthalmology,” said Michael
Goldstein, M.D., Chief Medical Officer of Ocular Therapeutix. “We are
excited about our progress to date and remain dedicated in our work to
enhance the strength and depth of our pipeline.”
Ocular Therapeutix Presentations at ARVO, Honolulu, HI:
Efficacy & Tolerability of OTX-TKI, a Sustained Hydrogel Delivery
System for a Tyrosine Kinase Inhibitor, in a VEGF Induced Retinal
Leakage Model Through 12 Months.
Tuesday, May 1, 2018; 4:00
PM – 4:15 PM - Room 314
Safety Analysis of a Sustained Release Travoprost Intracameral
Hydrogel Implant in Beagle Dogs.
Monday, April 30, 2018; 8:15
AM – 10:15 AM in Exhibit/Poster Hall
Efficacy and Pharmacokinetics of a Sustained Release Travoprost
Intracameral Hydrogel Implant in Beagle Dogs.
30, 2018; 8:15 AM – 10:15 AM in Exhibit/Poster Hall.
Effectiveness of Sustained Release TKI Hydrogel Combined with
Bevacizumab in a VEGF Induced Retinal Leakage Model Through 12 Months.
April 29, 2018; 4:00 PM – 4:15 PM in Exhibit/Poster Hall
About OTX-TIC (travoprost implant) for Intracameral Injection
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 four to six months. Preclinical
studies in beagles have demonstrated sustained intraocular pressure
reduction and maintenance of drug levels in the aqueous humor. Ocular
Therapeutix has submitted an investigational new drug application (IND)
for OTX-TIC and plans to initiate clinical trials in the second quarter
About OTX-TKI (tyrosine kinase inhibitor implant) Intravitreal
OTX-TKI is a bioresorbable hydrogel that contains TKI particles in an
injectable fiber. OTX-TKI is designed to deliver drug to the target
tissues for a period of up to 12 months, thereby potentially extending
the dosing interval from the 1-2 month frequency needed with the current
standard of care. Ocular Therapeutix has performed pharmacokinetic,
efficacy, and tolerability preclinical testing on OTX-TKI and plans to
initiate a Phase 1 clinical trial in the second quarter of 2018.
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.
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
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Source: Ocular Therapeutix, Inc.
Senior Vice President, Commercial