Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical
company focused on the development, manufacturing and
commercialization of innovative therapies for diseases and
conditions of the eye, today presented data from preclinical
studies evaluating the efficacy, tolerability and pharmacokinetics
of its sustained release intravitreal tyrosine kinase inhibitor
(TKI) depot (OTX-TKI) using the Company’s proprietary bioresorbable
hydrogel fiber technology at the Association for Research in Vision
and Ophthalmology (ARVO) Annual Meeting in Baltimore, MD.
Tyrosine kinase inhibitors have shown promise in the treatment
of wet age-related macular degeneration (AMD). However, attempts to
administer topical or systemic TKIs for AMD have been limited by
bioavailability and off-target effects.
In this study, the OTX-TKI investigational drug product was
well-tolerated, and high tissue levels of TKI were maintained for
up to 6 months in Dutch belted rabbits. For the first time, the
ability to deliver an efficacious dose of TKI to the posterior
segment of the eye for the treatment of VEGF-induced retinal
leakage was demonstrated for an extended duration of up to six
months.
“These preclinical studies of OTX-TKI have demonstrated the
ability to deliver and maintain high therapeutic tissue levels of
TKI in the vitreous humor, retina and choroid,” said Jonathan H.
Talamo, M.D., Chief Medical Officer of Ocular Therapeutix. “With
these positive results from our preclinical studies, we are looking
forward to beginning our Phase 1 trial of OTX-TKI later this
year.”
Four posters evaluating the OTX-TKI depot were presented at the
ARVO Annual Meeting:
- “Pharmacokinetics of a 6 month
Sustained Hydrogel Delivery System for Tyrosine Kinase Inhibitors
in Dutch Belted Rabbits” - Posterboard #B0488, Abstract
#1984-B0488
The pharmacokinetics over 6 months of sustained delivery from
the OTX-TKI depot placed by intravitreal injection in Dutch belted
rabbits were evaluated. OTX-TKI produced significant and increasing
levels of TKI in the vitreous humor, retina and choroid at months 1
through 6 without clinical evidence of local toxicity. Plasma
levels were below the level of quantification, suggesting minimal
risk of systemic toxicity.
- “Tolerability of a 6 month Sustained
Hydrogel Delivery System for Tyrosine Kinase Inhibitors in Dutch
Belted Rabbits” - Posterboard #B0460, Abstract #1956-B0460
The tolerability of sustained delivery of OTX-TKI depot
delivered via intravitreal injection through 6 months was evaluated
in naïve Dutch belted rabbits (n=9). Serial clinical examinations
showed that OTX-TKI was well-tolerated, with no sign of
inflammatory response or other abnormalities, and showed minimal
histopathologic changes at 1, 3 and 6 months.
- “Tolerability of a Shape Changing
Intravitreal Hydrogel Depot” - Posterboard #B0484, Abstract
#1980-B0484
The tolerability of an OTX-TKI depot delivered via intravitreal
injection in Dutch belted rabbits through 6 months was
investigated. Serial clinical examinations showed no sign of
inflammatory response or abnormal chorioretinal morphology. At 1, 3
and 6 months, histopathologic analysis demonstrated minimal changes
from baseline measurement in cornea, conjunctiva, sclera, choroid,
retina, and vitreous humor, suggesting the hydrogel was
well-tolerated in the Dutch belted model.
- “Efficacy of a 6 month Sustained
Hydrogel Delivery System for Tyrosine Kinase Inhibitors in a
VEGF Induced Retinal Leakage Model” - Posterboard
#B0472, Abstract #1968-B0472
The efficacy over 6 months of sustained delivery of an OTX-TKI
depot placed via intravitreal injection was investigated in a Dutch
belted rabbit, vascular endothelial growth factor (VEGF) induced,
retinal leakage model. Eyes were challenged with VEGF injection at
2, 3 and 6 months and were evaluated for leakage. OTX-TKI
significantly suppressed leakage and showed minimal to no vascular
leakage through 6 months. Blank control eyes showed high tortuosity
and leakage at all time points. For the first time, this study
demonstrated the ability to deliver an efficacious dose of TKIs to
the posterior segment of the eye using the OTX-TKI delivery
platform, and the potential to serve as an alternative to the once
every 4-6 week injections which are the current standard of
care.
About OTX-TKI (tyrosine kinase inhibitor)
OTX-TKI is a preformed, bioresorbable hydrogel fiber depot with
anti-angiogenic properties delivered by intravitreal tyrosine
kinase inhibitor injection. Currently OTX-TKI is under initial
preclinical investigation as a novel extended release drug product
candidate.
About Retinal Diseases
Retinal diseases such as age-related macular degeneration (AMD),
retinal vein occlusion (RVO) and diabetic macular edema (DME) can
be devastating to eyesight, causing central and/or peripheral
vision loss. AMD is one of the most common retinal diseases,
affecting more than 2 million Americans alone, and is the leading
cause of blindness in the United States.
Current therapies for retinal diseases require monthly
injections, which have shown to manage the progression of these
diseases to prevent further vision loss and, in some cases, gain
visual acuity. However, these frequent intravitreal injections can
increase the risk of infection, retinal detachment, and/or
hemorrhage.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company
focused on the development, manufacturing and commercialization of
innovative therapies for diseases and conditions of the eye using
its proprietary hydrogel platform 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. The FDA has accepted the Company’s NDA
resubmission for DEXTENZA for the treatment of ocular pain
following ophthalmic surgery and has established a PDUFA target
action date of July 19, 2017. If approved, the Company
intends to submit a supplement to its NDA for ocular inflammation.
OTX-TP (travoprost insert) is in Phase 3 clinical development for
glaucoma and ocular hypertension. Ocular Therapeutix is
also evaluating injectable drug delivery 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 the development and
regulatory status of the Company’s product candidates, such as the
Company’s expectations and plans regarding regulatory submissions
for and the timing and conduct of clinical trials of DEXTENZA™ for
the treatment of post-surgical ocular inflammation and pain,
including our expectations regarding the NDA filed with
the FDA and the FDA’s response to the resubmitted NDA,
and the potential impact of the re-inspection of manufacturing
operations, 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 technology,
the potential utility of any of the Company’s product candidates,
potential commercialization of the Company’s product candidates,
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 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: http://www.businesswire.com/news/home/20170509006517/en/
MediaMedical DynamicsSandra Correa, 646-599-8637Business
& Media Group
Directorscorrea@rxmedyn.comorInvestorsBurns McClellan on
behalf of Ocular TherapeutixSteve Klass,
212-213-0006sklass@burnsmc.comorOcular TherapeutixScott
CorningVice President of Marketing & Commercial
Operationsscorning@ocutx.com
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