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, announced abstracts from its clinical and preclinical research will be highlighted at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, April 28 – May 2, in Vancouver B.C., and at the American Society of Cataract and Refractive Surgery (ASCRS) Symposium, May 3 -9, in San Diego, CA.
"We are very excited for the planned DEXTENZA® launch. The data being presented, pooled from three Phase 3 clinical trials, demonstrate the benefit DEXTENZA provides in treating both ocular pain and inflammation after cataract surgery,” commented Michael Goldstein, M.D., MBA, Chief Medical Officer of Ocular Therapeutix. “We are also excited to be presenting additional data that demonstrate the breadth of our pipeline and the flexibility of our hydrogel platform by highlighting a number of product candidates we are developing for both front- and the back-of-the-eye diseases.”
Poster Presentations at ARVO Annual Meeting, Vancouver, B.C.:
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Pharmacokinetics of OTX-CSI, a Sustained Release Cyclosporine
Intracanalicular Insert in Beagles. Vanslette A, Blizzard C,
Haberman P, Tomaszewski J, Rosales C, Metzinger JL, Goldstein MH,
Driscoll A
Sunday, April 28, 2019; 8:00 AM – 9:45 AM
West Exhibition Hall – B0424
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Efficacy & Tolerability of OTX-TKI, a Sustained Hydrogel Delivery
System for a Tyrosine Kinase Inhibitor, in a VEGF Induced Retinal
Leakage Model: 1 Year Results. Jarrett P, ElHayek R, Kahn E, Takach
S, Metzinger JL, Goldstein MH
Sunday, April 28, 2019; 1:00 PM – 2:45 PM
West Exhibition Hall – A0249
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Pharmacodynamic Effect and Corneal Wound Healing of OTX-BPI, a
Sustained Release Bupivacaine Intracanalicular Hydrogel Insert in
Beagle Dogs. ElHayek R, Dexter J, Bello N, Kahn E, Manning S,
Blizzard C, Driscoll A, Metzinger JL, Goldstein MH, Jarrett P
Monday, April 29, 2019; 11:15 AM – 1:00 PM
West Exhibition Hall – B0397
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Effect of OTX-TIC, a Sustained Release Travoprost Intracameral Implant
on Central Corneal Thickness in Beagles. Driscoll A, Blizzard C,
Desai A, Langh J, Buff N, Metzinger JL, Goldstein MH, Gelormini A
Tuesday, April 30, 2019; 11:45 AM – 1:30 PM.
West Exhibition Hall – A0115
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A Prospective, Multicenter, Open-Label First-in-Human Study to
Evaluate the Safety, Tolerability and Efficacy of OTX-TIC (travoprost)
Implant in Subjects with Primary Open-Angle Glaucoma or Ocular
Hypertension: Preliminary Findings. Goldstein MH, Walters T,
Goldberg D, Day D, Braun E, Metzinger JL
Tuesday, April 30, 2019; 11:45 AM – 1:30 PM
West Exhibition Hall – A0130
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Pharmacokinetics of OTX-TIC, a Sustained Release Travoprost
Intracameral Implant in Rabbits. Blizzard C, Desai A, Langh J, Buff
N, Metzinger JL, Goldstein MH, Gelormini A, Driscoll A
Tuesday, April 30, 2019; 11:45 AM – 1:30 PM
West Exhibition Hall – B0324
Abstracts and full session details can be found at www.arvo.org.
Paper Presentations at ASCRS in San Diego, CA:
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Evaluating the Safety, Tolerability and Efficacy of OTX-TIC, a
Travoprost Intracameral Implant, in Subjects with Glaucoma. Walters
T, Day D, Goldberg D, Braun E, Metzinger JL, Goldstein MH
Sunday, May 5, 2019; 3:42 PM – 3:47 PM
SDCC – Upper Level, Room 7A
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Management of Ocular Inflammation and Pain Following Cataract Surgery
with Dexamethasone Insert (0.4 mg). Tyson S, Bafna S, Berdahl J,
Walters T, Metzinger JL, Goldstein MH
Monday, May 6, 2019; 8:02 AM – 8:07 AM
SDCC – Upper Level, Room 1A
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Evaluating the Safety and Efficacy of DEXTENZA, a Dexamethasone Insert
(0.4 mg) for the Treatment of Ocular Itching. McLaurin E,
Torkildsen G, Sato M, Meier E, Gomes P, Metzinger JL, Goldstein MH
Monday, May 6, 2019; 2:11 PM – 2:16 PM
SDCC – Upper Level, Room 1B
Abstracts and full session details can be found at www.ascrs.org.
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 bioresorbable hydrogel-based
formulation technology. Ocular Therapeutix’s first commercial drug
product, DEXTENZA, is FDA-approved for the treatment of ocular pain
following ophthalmic surgery. OTX-TP (intracanalicular travoprost
insert) is an intracanalicular insert in Phase 3 clinical development
for the reduction of intraocular pressure in patients with primary
open-angle glaucoma and ocular hypertension. The Company’s earlier stage
assets include OTX-TIC, an extended-delivery intracameral travoprost
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
intravitreal implants include OTX-TKI, containing a tyrosine kinase
inhibitor (TKI), and, in collaboration with Regeneron, OTX-IVT, an
extended-delivery 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 commercialization of DEXTENZA, ReSure Sealant or any of
the Company’s product candidates, including the anticipated commercial
launch of, and the receipt of reimbursement codes for, DEXTENZA; 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 the prospects
for approvability of DEXTENZA for post-surgical ocular inflammation or
any other indications, OTX-TP for the treatment of primary open-angle
glaucoma and ocular hypertension, OTX-TIC for the treatment of primary
open-angle glaucoma and ocular hypertension, OTX-TKI for the treatment
of retinal diseases including wet AMD, and OTX-IVT as an
extended-delivery formulation of the VEGF trap aflibercept for the
treatment of retinal diseases including wet AMD; the Company’s
post-approval studies of ReSure Sealant and the Company’s ongoing
communications with the U.S. Food and Drug Administration regarding the
warning letter the Company received regarding ReSure Sealant; the
ongoing development of the Company’s extended-delivery hydrogel depot
technology; the potential utility of any 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 DEXTENZA, ReSure Sealant or any product candidate that
receives regulatory approval, including the conduct of post-approval
studies, the ability to retain regulatory approval of DEXTENZA, ReSure
Sealant or any product candidate that receives regulatory approval, the
ability to obtain reimbursement codes for DEXTENZA, the initiation,
timing 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 Company’s
existing indebtedness, the ability of the Company’s creditors to
accelerate the maturity of such indebtedness upon the occurrence of
certain events of default, 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 except as required by law. 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.