OTX-TKI was Well Tolerated and Demonstrated a
Favorable Safety Profile with no Drug-Related Ocular or Systemic
Serious Adverse Events (SAEs)
Sustained and Comparable CSFT and BCVA
Measurements at 7 Months between OTK-TKI Treated Subjects and
Aflibercept Treated Subjects
80% of Subjects were Rescue-Free up to 6 months
and 73% of Subjects Were Rescue-Free up to 7 months Following a
Single OTX-TKI Implant Injection
Conference Call to Discuss Results to be Held
at 8:00 a.m. ET
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 interim 7-month data from
its U.S. Phase 1 clinical trial evaluating OTX-TKI, the Company’s
axitinib intravitreal hydrogel implant being developed for the
treatment of wet age-related macular degeneration (wet AMD) and
other retinal diseases. The data will be presented in more detail
at the upcoming American Academy of Ophthalmology (AAO) 2022 Annual
Meeting Subspecialty Day being held in Chicago by Dilsher Dhoot, MD
on Friday, September 30th at 3:29 CT and can be accessed
approximately two hours after the presentation’s conclusion for 90
days by visiting the investors section of the Company’s website at
investors.ocutx.com.
“These interim results from our U.S.-based Phase 1 trial of
OTX-TKI for the treatment of wet AMD represent a significant
milestone for Ocular,” said Antony Mattessich, President and Chief
Executive Officer. “Wet AMD is a leading cause of blindness
affecting approximately 14 million individuals globally and
approximately 2 million in the U.S. alone. The data presented today
highlights the potential of OTX-TKI to become a
highly-differentiated product capable of providing a durable
anti-VEGF response that improves upon today’s standard of care in
the management of wet AMD and with potential in other retinal
diseases. We look forward to discussing our future development
plans with the FDA and, subject to those discussions, plan to
initiate a Phase 2 clinical trial in the third quarter of
2023.”
The U.S.-based Phase 1 clinical trial is a prospective,
multi-center, randomized, controlled study 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 in subjects
previously treated with anti-VEGF therapy. The trial is designed to
assess the safety, durability and tolerability of OTX-TKI, and to
assess biological activity in subjects by measuring visual acuity
and anatomical changes of the retina using optical coherence
tomography. The clinical trial enrolled a total of 21 subjects at
six clinical sites in the U.S., who were randomized 3:1 to the
OTX-TKI arm or the on-label every 8-week aflibercept injection
arm.
Based on the data cutoff of August 24, 2022, interim data from
the U.S.-based Phase 1 clinical trial showed that the single
OTX-TKI implant was generally well tolerated with a favorable
safety profile. There were no drug-related ocular or systemic
serious adverse events (SAEs) observed. One SAE of endophthalmitis
was observed in the OTK-TKI arm which occurred following the
mandated aflibercept injection at Month 1 and assessed by the
investigator as related to the injection procedure. There were no
reported adverse events such as elevated IOP, retinal detachment,
retinal vasculitis, or implant migration into the anterior chamber
observed in the OTX-TKI arm, and no subjects dropped out of either
arm.
There was one subject randomized to the OTX-TKI arm who was
incorrectly given aflibercept instead of sham injections at the
subject’s Month 3 and Month 5 visits. These were not rescue
treatments as the subject did not meet any rescue criteria. Since
this subject was not treated according to protocol, the subject has
been excluded from the analysis of biological activity (OTX-TKI:
n=15 and Aflibercept: n=5) but included in the safety analysis
(OTX-TKI: n=16 and Aflibercept: n=5).
The interim results showed subjects treated with a single
OTX-TKI implant demonstrated stable and sustained best corrected
visual acuity (BCVA) (mean change from baseline of -1.3 letters)
and central subfield thickness (CSFT) (mean change from baseline of
+9.2 µm) in the OTX-TKI arm at 7 months, which was comparable with
the aflibercept arm dosed every 8 weeks (mean change from BVCA
baseline of -1 letter; mean change from CSFT baseline of +0.4 µm).
The data also showed that 80% of subjects in the OTX-TKI arm were
rescue-free up to 6 months and 73% of subjects in the OTX-TKI arm
were rescue-free up to 7 months. (Table 1). These data have not
been reviewed by FDA.
Table 1. Monthly Rescue-Free Rates with
OTX-TKI (n=15)
Visits
Month 2
Month 3
Month 4
Month 5
Month 6
Month 7
Percentage of OTX-TKI subjects
Rescue-Free up to each Visit
100%
100%
93%
93%
80%
73%
“We are very encouraged by these interim results from our
U.S.-based Phase 1 clinical trial of OTX-TKI for the treatment of
wet AMD. This adds to our knowledge of the safety and biological
activity of a single OTX-TKI implant in a different population of
wet AMD than the Australia-based Phase 1 clinical trial where we
are studying subjects with uncontrolled subretinal or intraretinal
fluid. We are looking forward to advancing the development of
OTX-TKI in wet AMD and other retinal diseases,” said Rabia Gurses
Ozden, MD, Chief Medical Officer at Ocular Therapeutix.
“The favorable safety profile, stable and sustained visual
acuity and retinal thickness outcomes, and clinically meaningful
reduction in treatment burden in this double-masked, randomized
clinical trial of subjects controlled previously on standard of
care anti-VEGF injections is very exciting,” said 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.
Based on the positive data, the Company plans to complete its
analysis of the interim U.S. Phase 1 data, meet with the FDA to
discuss potential future clinical trial requirements and, subject
to those discussions, initiate a Phase 2 wet AMD clinical trial in
the third quarter of 2023. The Company also plans to follow
subjects in the Phase 1 trial at least until their respective
one-year anniversaries of initial dosing, in accordance with the
clinical trial protocol. Given the potential broad applicability of
OTX-TKI to other retina diseases, the Company also plans to
initiate a U.S.-based Phase 1 clinical trial to evaluate OTX-TKI
for the treatment of diabetic retinopathy in the first quarter of
2023.
OTX-TKI is protected by a composition of matter patent, U.S.
Patent Number 11,439,592, with an expiration date of March 2041.
Additional U.S. and foreign patent applications are pending.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team along with
Chief Medical Advisor, Retina, Peter K. Kaiser, MD will host a live
conference call and webcast today at 8:00 am Eastern Time.
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 investors.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 2 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 1-4 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 other retinal diseases;
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®, ReSure® Sealant, or any of the
Company’s product candidates; the development and regulatory status
of the Company’s product candidates, such as the Company’s
development of, OTX-TKI for the treatment of retinal diseases
including wet AMD,; 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 potential
market for OTX-TKI; 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 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
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, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20220927005508/en/
Investors Ocular Therapeutix Donald Notman Chief
Financial Officer dnotman@ocutx.com
or
ICR Westwicke 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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