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 12-month data from its Phase
1 U.S. clinical trial evaluating OTX-TKI, the Company’s axitinib
intravitreal hydrogel implant, for the treatment of wet age-related
macular degeneration (wet AMD). OTX-TKI is also being developed for
the treatment of diabetic retinopathy and other retinal diseases.
The data are being presented by Arshad M. Khanani, MD, MA,
principal investigator on the trial and Director of Clinical
Research at Sierra Eye Associates today at 6:29 p.m. ET (4:29 p.m.
MT) at the Clinical Trials at the Summit 2023 Meeting in Park City,
Utah. The presentation can be accessed by visiting the scientific
and medical presentations tab of the investor section of the
Company’s website at www.ocutx.com.
An investigational, bioresorbable hydrogel intravitreal implant,
OTX-TKI is designed to continuously deliver a potent tyrosine
kinase inhibitor, axitinib, for the treatment of wet AMD and other
VEGF-mediated retinal diseases. The 12-month data demonstrated
maintenance of controlled wet AMD subjects comparable to
aflibercept injections every eight weeks with a single
administration of OTX-TKI. Four subjects received rescue therapy
for the first time at Month 12, indicating the waning of OTX-TKI’s
therapeutic effect and potential disease reactivation, which helps
establish a re-dosing timeline for patients. No serious
drug-related ocular or systemic adverse events have been observed
in the trial.
“We are very pleased to see the durability in the 12-month
OTX-TKI data in previously treated patients with wet AMD,” said
Antony Mattessich, President and Chief Executive Officer of Ocular
Therapeutix. “Pharmacodynamic effects observed in this trial
support the characteristics of a treatment for wet AMD with
durability between 9 to 12 months with a single injection.
Following discussions with the FDA, we have two potential pivotal
designs and are prepared to initiate a first pivotal trial for
OTX-TKI in wet AMD as early as the third quarter of this year. We
are excited for what these data could mean for patients living with
VEGF-mediated retinal diseases.”
Summary of 12-Month Topline Data from U.S. Phase 1
Clinical Trial Evaluating OTX-TKI for Treatment of Wet
AMD
The U.S.-based Phase 1 clinical trial is a prospective,
multi-center, randomized, controlled study in subjects previously
treated with anti-VEGF therapy that is evaluating a 600 μg dose of
OTX-TKI in a single implant, with a 2 mg aflibercept injection four
weeks after the implant, compared to 2 mg aflibercept injections
administered every 8 weeks. The trial is designed to assess the
safety, durability and tolerability of OTX-TKI, and to assess
biological activity in subjects by measuring best corrected visual
acuity (BCVA) and central subfield thickness (CSFT) of the
retina.
The clinical trial enrolled a total of 21 subjects at six
clinical sites in the United States, who were randomized 3:1 to an
arm receiving a single OTX-TKI implant, with a 2 mg aflibercept
injection four weeks after implant injection, and an arm receiving
aflibercept injections every 8 weeks. One subject in the OTX-TKI
arm was not treated per protocol and has been removed from the
efficacy analysis, as the subject incorrectly received aflibercept
instead of a sham injection at Month 3 and 5 visits.
As of the data cutoff of April 14, 2023, there were no
drug-related ocular or systemic serious adverse events (SAEs)
observed in the OTX-TKI arm. As the Company previously announced at
the 10-month data readout, one SAE of endophthalmitis was observed
in the OTK-TKI arm, which occurred following the mandated
aflibercept injection at Month 1 and was assessed by the
investigator as related to the injection procedure. There were no
retinal detachment, retinal vasculitis, or implant migration into
the anterior chamber adverse events observed in the OTX-TKI arm,
and no subjects had dropped out of either arm as of the data
cutoff.
The results showed subjects treated with a single OTX-TKI
implant continued to demonstrate sustained BCVA (mean change from
baseline of -1.0 letters) and CSFT (mean change from baseline of
+20.2 μm) in the OTX-TKI arm at 12 months, which was comparable
with the aflibercept arm (mean change from BCVA baseline of +2.0
letters; mean change from CSFT baseline of -2.2 μm). 60% of OTX-TKI
subjects were rescue-free up to Month 12. At the Month 12 visit, an
additional four of the subjects were rescued. Overall, an 89%
reduction in treatment burden was observed in OTX-TKI treated
subjects at 12 months.
“We are encouraged by the 12-month data as the performance of
the OTX-TKI drug product continued to demonstrate that the implant
bioresorbs at an average of about eight to nine months with
axitinib remaining longer in the eye, potentially providing a
window to re-dose patients before disease reactivation starts,”
said Rabia Gurses Ozden, MD, Chief Medical Officer of Ocular
Therapeutix.
Dr. Khanani said: “We saw an 89% overall reduction in treatment
burden in patients treated with OTX-TKI. Approximately 73% of
patients either required no or only one supplemental anti-VEGF
injection through Month 12, which is clinically meaningful and
highlights the possibility of OTX-TKI being widely adopted in the
management of wet AMD.”
The Company is prepared to initiate a pivotal trial in wet AMD
as early as the third quarter of 2023, subject to obtaining the
necessary financing, which could be provided through a strategic
alliance. OTX-TKI is also being evaluated in other retinal
diseases. The Company recently completed enrollment of the Phase 1
HELIOS clinical trial to evaluate OTX-TKI for the treatment of
diabetic retinopathy and 6-month interim results are expected in
the first quarter of 2024.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team, including
Chief Medical Advisor, Retina, Peter K. Kaiser, MD, along with
OTX-TKI U.S. Phase 1 clinical trial investigator, Dr. Khanani, will
host a live conference call and webcast Monday, June 12, at 8:30
a.m. EDT for investors and analysts. Listeners can register for the
webcast via this link. Analysts wishing to participate in the
question and answer session should use this link. A replay of the
webcast will be available via the investor section of the Company’s
website at www.ocutx.com approximately two hours after the call’s
conclusion for 90 days following the webcast. Those who plan on
participating are advised to join 15 minutes prior to the start
time.
About OTX-TKI
OTX-TKI is an investigational bioresorbable, hydrogel implant
incorporating axitinib, a small molecule, multi-target, tyrosine
kinase inhibitor with anti-angiogenic properties, being evaluated
for the treatment of wet age-related macular degeneration (wet AMD)
and other retinal diseases.
About Wet Age-Related Macular Degeneration
Wet age-related macular degeneration (wet AMD) is a leading
cause of severe, irreversible vision loss affecting approximately
14 million individuals globally and 1.6 million in the United
States alone (2022 Market Scope® Retinal Pharmaceuticals Market
Report). Wet AMD causes vision loss due to abnormal new blood
vessel growth and hyperpermeability and associated retinal
vascularity in the macula, which is primarily stimulated by local
upregulation of vascular endothelial growth factor (VEGF). Without
prompt and continuous treatment to control this exudative activity,
patients develop irreversible vision loss. With proper treatment,
patients may maintain visual function for a period of time and may
temporarily regain lost vision. Challenges with current therapies
include repeated intraocular injections every 1 to 4 months,
treatment-related adverse events, patient compliance, and lack of
vision improvement.
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-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, 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, such as the Company’s development of
and the timing of planned pivotal clinical trials for OTX-TKI for
the treatment of retinal diseases including wet AMD and diabetic
retinopathy; the Company’s plans to advance the development of
OTX-TKI; the ongoing development of the Company’s extended-delivery
hydrogel depot technology; the potential utility of any of the
Company’s product candidates; the size of the potential market for
OTX-TKI; the Company’s ability to fund the planned and future
clinical development of its product candidates whether through
strategic alliances or other fundraising; the Company’s ability to
enter into and perform its obligations under collaborations; 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 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 interim clinical trial data such as the data reported in
this release will be indicative of the results of the trial upon
its completion or subsequent clinical trials in this and other
indications, availability of data from clinical trials and
expectations for regulatory submissions and approvals, the
Company’s scientific approach and general development progress, 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 Company’s ability to enter into strategic alliances or
generate additional funding on a timely basis, on favorable terms,
or at all, 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.
Investors
Ocular TherapeutixDonald NotmanChief Financial
Officerdnotman@ocutx.com orICR WestwickeChris Brinzey,
339-970-2843Managing Directorchris.brinzey@westwicke.com
MediaICR WestwickeBen Shannon,
443-213-0495ben.shannon@westwicke.com
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