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 provided a corporate update on the
progress of its key programs.
“2022 marked a year in which Ocular made good progress against
its corporate mission of becoming a mid-tier strategic within
ophthalmology,” said Antony Mattessich, President and CEO.
“DEXTENZA, despite challenging market conditions, has established
itself as a material and important product and demonstrated renewed
growth in the fourth quarter of 2022.”
Mr. Mattessich continued: “The highlight of our year at Ocular
was further development within our pipeline. At AAO in September,
we presented impressive interim 6- and 7-month data from our
U.S.-based Phase 1 clinical trial of OTX-TKI for the treatment of
wet AMD. We believe the data further strengthen our ongoing
development in wet AMD and supports proof of concept for OTX-TKI’s
potential in the treatment of VEGF-mediated vascular retinal
diseases, including diabetic retinopathy. Both wet AMD and diabetic
retinopathy represent large markets where durability could
significantly reduce the burden of anti-VEGF injections and improve
real-world outcomes for patients. With that in mind, we initiated a
Phase 1 clinical trial in diabetic retinopathy in December 2022 and
anticipate presenting interim data from this trial in 2023. We also
plan to report 9- and 10-month data from the U.S. Phase 1 trial of
OTX-TKI in wet AMD at the Angiogenesis meeting in February 2023.
Lastly, we plan to present much anticipated data from our Phase 2
clinical trial of OTX-TIC for the treatment of glaucoma in Q4 2023.
Overall, executing efficiently and working within the constraints
of existing resources, we believe that the Company can pull forward
our core development programs to be Phase 3-ready.”
Business Updates
DEXTENZA (dexamethasone ophthalmic insert) 0.4mg is FDA
approved for the treatment of ocular inflammation and pain
following ophthalmic surgery and ocular itching associated with
allergic conjunctivitis.
- Net product revenue of DEXTENZA for the fourth quarter of 2022
is estimated to be $13.6 million, which would represent growth of
approximately 14% over the previous quarter and approximately 11%
over the fourth quarter of 2021. DEXTENZA net product revenue for
the year is estimated to be $50.2 million, which would represent
growth of 20% over 2021.
- The Company believes DEXTENZA remains poised for continued
growth in 2023 with continued drug payment in the ambulatory
surgery center (ASC) setting through the non-opioid pain provision
and with a focus on the growing ophthalmic surgery market, more
than offsetting the loss of reimbursement in the hospital
outpatient department (HOPD) setting.
OTX-TKI (axitinib intravitreal implant) for the
potential treatment of wet AMD and other retinal vascular
diseases.
- The Company presented positive interim 6- and 7-month data from
its U.S.-based Phase 1 trial of OTX-TKI for the treatment of wet
AMD at the American Academy of Ophthalmology 2022 Annual Meeting.
- Interim data showed a single OTX-TKI implant was generally well
tolerated with no drug-related ocular or systemic serious adverse
events (SAEs).
- 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.
- 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 foveal
thickness (CSFT) (mean change from baseline of +9.2 µm) 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 Company intends to present 9-and 10-month interim data at
the upcoming Angiogenesis, Exudation, and Degeneration 2023 Meeting
at 8:10 am on Saturday, February 11th, 2023, and plans to follow
subjects at least until their respective one-year anniversaries of
initial dosing, in accordance with the clinical trial
protocol.
- The Company plans to meet with the FDA in early 2023 to discuss
potential future clinical trial requirements with the goal of being
in position to initiate a Phase 2/3 clinical trial for the
treatment of wet AMD as early as Q3 2023, subject to obtaining
additional funding for the trial from external sources, including
potentially a strategic alliance.
OTX-TKI (axitinib intravitreal implant) for the
potential treatment of Diabetic Retinopathy (DR)
- The Company believes that the interim 7-month data from the
U.S.-based Phase 1 clinical trial evaluating OTX-TKI for the
treatment of wet AMD, as well as the product’s mechanism of action,
support proof of concept for the potential treatment of
VEGF-mediated retinal vascular diseases, including diabetic
retinopathy.
- DR represents a large, unmet need without an established
standard-of-care treatment. Studies show treatment rates as low as
15% in patients with type 2 diabetes and DR is the leading cause of
blindness in American working-age adults. Nearly 24,000 patients go
blind from DR complications each year in the United States despite
DR being a highly treatable disease with early diagnosis and
treatment. Patients at risk for or suffering from DR may benefit
from the extended durability of a treatment lasting 6 to 12 months.
The Company believes that the lack of a standard of care for the
treatment of DR may offer a straightforward regulatory path.
- The Company initiated a U.S.-based Phase 1 clinical trial for
the treatment of DR in December 2022. This trial will include
approximately 10 sites and is designed to include approximately 21
patients randomized 2:1 to either a 600 µg OTX-TKI single implant
containing axitinib or sham control.
- Subject to the results of this trial, discussions with the FDA
and additional financing to fund the trial, the Company believes it
could be well-positioned to initiate its first Phase 3 pivotal
trial for the treatment of DR as early as Q1 2024.
OTX-TIC (travoprost intracameral implant) for the
treatment of patients with primary open-angle glaucoma or ocular
hypertension.
- The Company continues to enroll its U.S.-based Phase 2
prospective, multi-center, randomized, controlled clinical trial
evaluating the safety, tolerability, and efficacy of OTX-TIC for
the treatment of patients with primary open-angle glaucoma or
ocular hypertension. The trial is designed to evaluate whether
OTX-TIC can demonstrate a clinically meaningful decrease in
intraocular pressure while preserving endothelial cell health while
enabling repeat dosing.
- Due to observed elevations in intraocular pressure in the
OTX-TIC 5 µg arm of the trial, the Company has decided to terminate
enrollment in the 5 µg arm of the trial and continue forward with
the OTX-TIC 26 µg and Durysta® arms of the trial. The Company
expects that the Phase 2 clinical trial will consist of
approximately 86 patients: approximately 35 patients in the OTX-TIC
26 µg treatment arm, 35 patients in the Durysta arm and 16 patients
that were previously enrolled in the OTX-TIC 5 µg treatment
arm.
- The Company plans to provide top-line data from the trial in Q4
2023.
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
- The Company continues to advance both dry eye programs and
plans to launch a small study in the first half of 2023 to evaluate
the performance of OTX-DED versus fast-dissolving collagen plugs
and no inserts at all in order to identify a proper placebo control
for any future trials of these product candidates.
- The Company plans to use the results of this study to inform
the next steps for both OTX-DED and OTX-CSI.
2022 Preliminary Results
- On a preliminary basis, total net product revenue for Q4 2022
and the full year 2022 are estimated to be approximately $13.6
million and approximately $50.2 million, respectively. Sequential
quarterly growth from Q3 2022 to Q4 2022 is expected to be
approximately 14%, signaling a return to quarterly growth from
DEXTENZA, driven by sales for the treatment of post-surgical
inflammation and pain. Growth in annual total net product revenue
from 2021 to 2022 is estimated to be approximately 15%.
- On a preliminary basis, the Company had estimated cash and cash
equivalents of $102.3 million as of December 31, 2022. Consistent
with the strategy of bringing the Company’s core development
programs in wet AMD, diabetic retinopathy, glaucoma and dry eye to
Phase 3-ready status, the Company believes that it has sufficient
cash and cash equivalents to fund planned operating expenses, debt
service obligations and capital expenditure requirements through
the middle of 2024.
- The Company plans to post an updated corporate presentation
that can be found in the ‘Investors’ section of its corporate
website on Monday, January 9, 2023.
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.
About DEXTENZA
DEXTENZA is FDA approved for the treatment of ocular
inflammation and pain following ophthalmic surgery and ocular
itching associated with allergic conjunctivitis. DEXTENZA is a
corticosteroid intracanalicular insert placed in the punctum, a
natural opening in the inner portion of the lower eyelid, and into
the canaliculus and is designed to deliver dexamethasone to the
ocular surface for up to 30 days without preservatives. DEXTENZA
resorbs and exits the nasolacrimal system without the need for
removal.
Please see full Prescribing and Safety Information at
www.DEXTENZA.com.
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 and prospects for approvability of OTX-TIC for the
treatment of primary open-angle glaucoma or ocular hypertension,
OTX-TKI for the treatment of retinal diseases including wet AMD and
diabetic retinopathy, OTX-DED for the short-term treatment of the
signs and symptoms of dry eye disease, and OTX-CSI for the chronic
treatment of dry eye disease; the Company’s plans to advance the
development of its product candidates or preclinical programs; the
potential utility of any of the Company’s product candidates; the
size of potential markets for the Company’s product candidates; the
potential benefits and future operations of Company collaborations,
including any potential future costs or payments thereunder;
estimated 2022 financial results, including estimated net product
revenue and cash and cash equivalents; 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 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 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, uncertainties as to the Company’s preliminary
financial results for Q4 2022 and 2022, which are estimates based
on preliminary and unaudited information, subject to the completion
of financial closing procedures and have not been audited or
reviewed by the Company’s independent public accounting firm, 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,
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
MediaOcular TherapeutixScott CorningSenior Vice
President, Commercialscorning@ocutx.com
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