Ocular Therapeutix™ To Present 12-Month Top-Line Data from U.S.-Based Phase 1 Clinical Trial of OTX-TKI in Wet Age-Related Macular Degeneration at the 2023 Clinical Trials at the Summit Annual Meeting
05 Junho 2023 - 5:01PM
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 that 12-month data from the U.S.-based Phase 1 trial
evaluating OTX-TKI for the treatment of wet AMD will be presented
at the 2023 Clinical Trials at the Summit Annual Meeting being held
on June 10th in Park City, Utah. The Company will also participate
in a panel discussing the challenges of bringing novel treatments
to the market. Ocular Therapeutix is also sponsoring a presentation
discussing the Company's proprietary bioresorbable hydrogel-based
formulation technology and retina focused clinical programs. A
conference call discussing the 12-month data from the U.S.-based
Phase 1 clinical trial of OTX-TKI presented at the Clinical Trials
at the Summit will be hosted by the Ocular Therapeutix management
team on Monday, June 12th at 8:30 AM ET.
“We look forward to presenting the 12-month data update from our
U.S.-based trial evaluating OTX-TKI for the treatment of wet AMD,”
stated Rabia Gurses Ozden, MD, Chief Medical Officer of Ocular
Therapeutix. “Our most recent update at 10-months observed that
CSFT and BCVA measurements at 10 months were comparable between
OTX-TKI treated subjects and aflibercept treated subjects with a
92% reduction in treatment burden in the OTX-TKI arm. This new data
will include additional information regarding the pharmacodynamics
of OTX-TKI at month 12.”
Presentations at Clinical Trials at the
Summit:
- 12-Month Update on Randomized, Controlled, Trial of
OTX-TKI (Axitinib Intravitreal Implant) for the Treatment of Wet
AMDDate / Time: Saturday, June 10th at 4:29 PM
MDTPresenter: Arshad M. Khanani, MD, Director of Clinical Research
at Sierra Eye AssociatesThe presentation will be posted on the
Company’s website at approximately 4:30 PM MDT the same day under
the Investors tab, Events and Presentations/Scientific and Medical
Presentations.
- Challenges of Bringing Novel Treatment Options to the
MarketPanel Date/Times: Saturday, June 10th at 10:44 AM
MDTPanelists: Mohamed Genead, Alexander Hardy, Antony Mattessich,
Reenie McCarthy, Joel Naor, Victor PerlrothModerator: Jeffrey
Heier, MD, Director of the Vitreoretinal Service and Retina
Research at Ophthalmic Consultants of Boston and member of the
Board of Directors, Ocular Therapeutix, Inc.
- Ocular Therapeutix: Transforming Ophthalmic Care with
Innovative TherapiesSponsored presentation Date/Times:
Saturday, June 10th at 5:03 PM MDTPresenter: Peter K. Kaiser, MD,
Chaney Family Endowed Chair in Ophthalmology Research and Professor
of Ophthalmology at the Cleveland Clinic Lerner College of Medicine
and Chief Medical Advisor, Retina at Ocular Therapeutix
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 include: OTX-TKI
(axitinib intravitreal implant), currently in Phase 1 clinical
trials for the treatment of wet AMD and diabetic retinopathy;
OTX-TIC (travoprost intracameral implant), currently in a Phase 2
clinical trial for the treatment of primary open-angle glaucoma or
ocular hypertension; and OTX-DED (dexamethasone intracanalicular
insert) for the short-term treatment of the signs and symptoms of
dry eye disease; and OTX-CSI (cyclosporine intracanalicular insert)
for the chronic treatment of dry eye disease, both of which have
completed Phase 2 clinical trials.
Forward Looking Statements
Any statements in this press release about future expectations,
plans, and prospects for the Company, including the
commercialization of DEXTENZA® or any of the Company’s products or
product candidates; the development and regulatory status 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 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 or any product or product candidate
that receives regulatory approval, including the conduct of
post-approval studies, the ability to retain regulatory approval of
DEXTENZA or any product or 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 will be indicative of the results of
subsequent clinical trials in the same or other indications or that
interim data will be indicative of the full data from a clinical
trial, uncertainties as to the timing and 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, any additional
financing needs, the Company’s ability to recruit and retain key
personnel, 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.
InvestorsOcular TherapeutixDonald NotmanChief
Financial Officerdnotman@ocutx.com
or
ICR WestwickeChris Brinzey, 339-970-2843Managing
Directorchris.brinzey@westwicke.com
MediaICR WestwickeOcularPR@icrinc.com
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