Ocular Therapeutix™ to Present Pre-Clinical and Clinical Data at the 2022 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting
April 25 2022 - 8:00AM
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 multiple scientific presentations
at the Association for Research in Vision and Ophthalmology (ARVO)
Annual Meeting being held May 1-4 in Denver, Colorado and May 11-12
virtually.
“At this year’s Annual Meeting, we are thrilled to be presenting
clinical and pre-clinical data from our lead programs as well as
from programs that are a part of our early-stage pipeline,”
commented Michael Goldstein, MD, MBA, President, Ophthalmology and
Chief Medical Officer of Ocular Therapeutix. “The data being
presented continues to highlight the depth of our hydrogel platform
and its potential to provide solutions that improve efficacy and
reduce the complexity and burden of the current standard of care
for a number of diseases in both the front and back-of-the-eye. As
we continue to advance our pipeline forward, we remain excited
about the progress we have seen to-date and future expansion
capabilities into other areas of unmet need.”
Ocular Therapeutix Presentations at ARVO:
OTX-DED (dexamethasone intracanalicular
insert) (Dry Eye Disease):
- Title: Efficacy and Safety of OTX-DED Dexamethasone
Intracanalicular Insert in Subjects with Dry Eye Disease: A
Multicenter, Randomized, Vehicle-Controlled Phase 2 Study
Session Title: Dry Eye, Clinical Session Date/Times:
May 2, 2022 from 2:30 PM to 4:30 PM EDT Presentation type:
Poster session (virtual) Presenter: Lisa Nijm
OTX-TKI (axitinib intravitreal implant)
(wet AMD and other retinal diseases):
- Title: A Safety and Pharmacokinetic Study of a Novel
Hydrogel-based Axitinib Intravitreal Implant (OTX-TKI) in Non-Human
Primates Session Title: AMD and diabetic retinopathy
Session Date/Times: May 1, 2022 from 2:15 PM to 4:15 PM EDT
Presentation type: Poster session Presenter: Erica
Kahn
- Title: A 6-Month GLP Toxicology Study of a Novel
Hydrogel-based, Axitinib Intravitreal Implant (OTX-TKI) in
Non-Human Primates Session Title: AMD and diabetic
retinopathy Session Date/Times: May 1, 2022 from 2:15 PM to
4:15 PM EDT Presentation type: Poster session
Presenter: Chintan Patel
OTX-TIC (travoprost intracameral
implant) (primary open-angle glaucoma or ocular
hypertension):
- Title: Safety and Pharmacodynamic Assessment of Repeated
Intracameral Travoprost Implant Administration in Beagle Dogs
Session Title: Pharmacology/cellular mechanisms Session
Date/Times: May 3, 2022 from 3:00 PM to 5:00 PM EDT
Presentation type: Poster session Presenter: Charles
Blizzard
Early-stage pipeline
programs:
- Title: Pharmacokinetics of a Hydrogel-based Besifloxacin
Intracanalicular Insert in Canines Session Title:
Anti-inflammatory agents, antibiotics and antivirals Session
Date/Times: May 2, 2022 from 5:00 PM to 7:00 PM EDT
Presentation type: Poster session Presenter: Megan
Priem
- Title: Pharmacokinetics of a Hydrogel-based Nepafenac
Intracanalicular Insert in Canines Session Title: Aqueous
humor dynamics and IOP Session Date/Times: May 1, 2022 from
5:36 PM to 5:53 PM EDT Presentation type: Paper session
Presenter: Oktay Uzun
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 an FDA-approved corticosteroid for the treatment of
ocular inflammation and pain following ophthalmic surgery and
ocular itching associated with allergic conjunctivitis. Ocular
Therapeutix’s earlier stage development assets includes OTX-TKI
(axitinib intravitreal implant), currently in Phase 1 clinical
trials for the treatment of wet AMD and other retinal diseases.
OTX-TIC (travoprost intracameral implant) recently began a Phase 2
clinical trial to evaluate the reduction of intraocular pressure in
patients with primary open-angle glaucoma or ocular hypertension.
Ocular Therapeutix has also completed Phase 2 clinical trials for
OTX-CSI (cyclosporine intracanalicular insert) for the chronic
treatment of dry eye disease and OTX-DED (dexamethasone
intracanalicular insert) for the short-term treatment of the signs
and symptoms of dry eye disease. Ocular Therapeutix's first
product, ReSure® Sealant, is an FDA-approved device to prevent
wound leaks in 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; the commercial launch of, and the
effectiveness of and amounts applicable to reimbursement codes for,
DEXTENZA; the conduct of post-approval studies of and compliance
with related labeling requirements for DEXTENZA and ReSure Sealant;
the Company’s sales and marketing strategy; the development and
regulatory status of the Company’s product candidates, such as the
Company’s development of and prospects for approvability of OTX-CSI
for the chronic treatment of dry eye disease, OTX-DED for the
short-term treatment of the signs and symptoms of dry eye disease,
OTX-TIC for the treatment of primary open-angle glaucoma or ocular
hypertension, and OTX-TKI for the treatment of retinal diseases
including wet AMD; the ongoing development of the Company’s
extended-delivery hydrogel depot technology; the size of potential
markets for our product candidates; the potential utility of any of
the Company’s product candidates; the potential benefits and future
operations of Company collaborations, including any potential
future costs or payments thereunder; projected net product revenue,
in-market sales and other financial and operational metrics of
DEXTENZA and ReSure Sealant; potential market sizes for indications
targeted by the Company’s product candidates, if approved; the
expected impact of the COVID-19 pandemic on the Company and its
operations; 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 preclinical and 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, 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 successfully
develop and commercialize products for the ophthalmology office
setting, the ability to retain regulatory approval of DEXTENZA,
ReSure Sealant or any product candidate that receives regulatory
approval, the ability to maintain and the sufficiency of product,
procedure and any other reimbursement codes for DEXTENZA, the
initiation, timing, conduct and outcomes of clinical trials,
whether clinical trial data such as the data reported in this
release will be indicative of the results of subsequent clinical
trials, availability of data from clinical trials and expectations
for regulatory submissions and approvals, the Company’s ability to
enter into and perform its obligations under collaborations and the
performance of its collaborators under such collaborations, the
Company’s scientific approach and general development progress, the
availability or commercial potential of the Company’s product
candidates, the Company’s ability to meet supply demands, the
Company’s ability to generate its projected net product revenue and
in-market sales on the timeline expected, if at all, 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 severity and duration of the COVID-19 pandemic
including its effect on the Company’s revenues and relevant
regulatory authorities’ operations, any additional financing needs
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 press 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, whether as a result of new information, future events or
otherwise, 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 press
release.
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version on businesswire.com: https://www.businesswire.com/news/home/20220425005249/en/
Investors Ocular Therapeutix Donald Notman Chief
Financial Officer dnotman@ocutx.com
or
Westwicke, an ICR Company Chris Brinzey, 339-970-2843 Managing
Director chris.brinzey@westwicke.com
Media Ocular Therapeutix Scott Corning Senior Vice
President, Commercial scorning@ocutx.com
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