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 that it has dosed the first
patient in its Phase 2 clinical trial of OTX-DED (dexamethasone
intracanalicular ophthalmic insert) for the short-term treatment of
the signs and symptoms of dry eye disease.
“We are excited to have recently begun dosing patients in the
Phase 2 clinical trial of OTX-DED,” said Michael Goldstein, MD,
MBA, President, Ophthalmology and Chief Medical Officer. “Many dry
eye patients experience episodic flares of their signs and symptoms
related primarily to inflammation. Topical steroids are commonly
used for the short-term treatment of dry eye but all of them
contain preservatives that can lead to ocular surface toxicities
such as itching and stinging and, when used more chronically, other
adverse events such as elevated intraocular pressure or cataracts.
OTX-DED is a new, investigational, physician-administered,
preservative-free intracanalicular insert designed to deliver
either 0.2 or 0.3 mg doses of dexamethasone that has the potential
to provide effective treatment with fewer of those toxicities and
adverse events. Along with OTX-CSI, our cyclosporin-containing
intracanalicular insert, we now have two potentially transformative
dry eye product candidates in Phase 2 development, one to
chronically treat dry eye disease (OTX-CSI) and the other to
acutely treat dry eye disease (OTX-DED), thereby effectively
covering the broad spectrum of the approximately $5 billion global
dry eye disease market.”
The Phase 2 clinical trial is a U.S.-based, randomized,
double-masked, vehicle-controlled, multi-center trial evaluating
two different-strength formulations of OTX-DED (dexamethasone
intracanalicular ophthalmic insert) in a total of approximately 150
subjects with dry eye disease. This trial is designed to assess the
safety and efficacy of these two formulations of OTX-DED for the
short-term treatment of signs and symptoms of dry eye disease by
evaluating bulbar conjunctival hyperemia, corneal fluorescein
staining eye dryness symptoms using visual analog scale (VAS), and
other secondary endpoints in comparison with a matched vehicle
control hydrogel insert.
About Dry Eye Disease
Dry eye disease is a common, multifactorial disease of the tears
and ocular surface that results in symptoms of discomfort (such as
burning sensation, itching, redness, stinging, pain and foreign
body sensation), visual disturbance, and tear film instability that
can cause potential damage to the ocular surface. Inflammation of
the lacrimal gland and ocular surface have been shown to play a key
role in dry eye disease, resulting in a reduction in tear
production.
The global market for dry ocular surface disease, which we refer
to as dry eye disease, was estimated by Market Scope at $5.1
billion in 2019 with the U.S. market representing $2.1 billion.
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 (dexamethasone ophthalmic insert) 0.4 mg for
intracanalicular use, is FDA-approved for the treatment of ocular
inflammation and pain following ophthalmic surgery. Ocular
Therapeutix has also submitted a Supplemental NDA for DEXTENZA to
include the treatment of ocular itching associated with allergic
conjunctivitis as an additional approved indication. Ocular
Therapeutix’s earlier stage development assets currently in Phase 1
clinical trials include OTX-TKI (axitinib intravitreal implant) for
the treatment of wet AMD and other retinal diseases and OTX-TIC
(travoprost intracameral implant) for the reduction of intraocular
pressure in patients with primary open-angle glaucoma or ocular
hypertension. Ocular Therapeutix is currently evaluating each of
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 in Phase 2 clinical trials. Also,
in collaboration with Regeneron, OTX-AFS (aflibercept
suprachoroidal injection) is in pre-clinical development as an
extended-delivery formulation of aflibercept for the treatment of
retinal diseases. 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
effectiveness of reimbursement codes for, DEXTENZA; the conduct of
post-approval studies of DEXTENZA; the development and regulatory
status of the Company’s product candidates, such as the Company’s
development of and prospects for approvability of DEXTENZA for
additional indications including allergic conjunctivitis, OTX-DED
for the short-term treatment of the signs and symptoms of dry eye
disease, OTX-CSI for the chronic treatment of dry eye disease,
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 OTX-AFS as an extended-delivery formulation
of the VEGF trap aflibercept for the treatment of retinal diseases
including wet AMD; the potential receipt of a target action date
under PDUFA; 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
operation of the collaboration with Regeneron Pharmaceuticals,
including any potential future payments thereunder; projected net
product revenue and other financial metrics of DEXTENZA; 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 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 reimbursement codes for DEXTENZA,
the initiation, timing and conduct of clinical trials, availability
of data from clinical trials and expectations for regulatory
submissions and approvals, 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 generate its projected net product revenue 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 outcome of the
Company’s ongoing legal proceedings, the severity and duration of
the COVID-19 pandemic including its effect on the Company’s and
relevant regulatory authorities’ operations, any additional
financing needs or other actions 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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210301005290/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
Ocular Therapeutix (NASDAQ:OCUL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Ocular Therapeutix (NASDAQ:OCUL)
Historical Stock Chart
From Apr 2023 to Apr 2024