BEDFORD, Mass.--(BUSINESS WIRE)--May 1, 2019--
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 the Centers for Medicare and Medicaid Services (CMS) has included
DEXTENZA® (dexamethasone ophthalmic insert) 0.4mg for intracanalicular
use on its list of products that have been preliminarily recommended for
a new dedicated Healthcare Common Procedure Coding System (HCPCS)
J-code, effective January 1, 2020.
A J-Code is a permanent product code established by CMS for the
Prospective Payment System used to report drugs that ordinarily cannot
be self-administered. J-codes are familiar to both medical practices and
their billing staffs, as well as Medicare (Part B and Part C) and
commercial insurers. As a result, J-codes allow for a simpler and more
convenient reimbursement process. The Company believes that receipt of a
J-code will facilitate reimbursement for a greater number of patients to
be treated with DEXTENZA.
As previously disclosed, the Company also submitted an application for a
HCPCS C-code for transitional pass-through payment status and expects
notification from CMS by mid-year 2019 on the status of the C-code
application. A C-code is a unique temporary product code established by
CMS for the Prospective Payment System used to report claims for
hospital outpatient department services and procedures. If the Company
receives a C-code, it should enable the use and reimbursement of
DEXTENZA until such time as CMS may potentially approve the J-code and
such approval becomes effective.
DEXTENZA is the first FDA-approved intracanalicular insert delivering
dexamethasone to treat post-surgical ocular pain for up to 30 days with
a single administration. DEXTENZA is a resorbable, preservative-free
ophthalmic insert that is placed in the lower lacrimal punctum and into
the canaliculus of the eye.
“We are pleased that CMS has recommended a unique J-code for DEXTENZA,”
said Antony Mattessich, President and Chief Executive Officer.
“Finalization of this recommendation later this year would be an
important achievement for the Company and for the potential commercial
success of DEXTENZA.”
Per the HCPCS J-code review process, CMS is scheduled to hold a public
hearing in May. The final list of J-codes is anticipated to be published
in fourth quarter of 2019, with new codes expected to take effect on
January 1, 2020.
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 FDA-approved
for the treatment of ocular pain following ophthalmic surgery. OTX-TP
(intracanalicular travoprost insert) is an intracanalicular insert in
Phase 3 clinical development for the reduction of intraocular pressure
in patients with primary open-angle glaucoma and ocular hypertension.
The Company’s earlier stage assets include OTX-TIC, an extended-delivery
intracameral travoprost implant for the reduction of intraocular
pressure in patients with glaucoma and ocular hypertension, as well as
sustained release intravitreal implants for the treatment of retinal
diseases. These intravitreal implants include OTX-TKI, containing a
tyrosine kinase inhibitor (TKI), and, in collaboration with Regeneron,
OTX-IVT, an extended-delivery protein-based anti-vascular endothelial
growth factor (VEGF) trap. Ocular Therapeutix’s first product, ReSure®
Sealant, is FDA-approved to seal 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,
including the anticipated commercial launch of, and the receipt of
reimbursement codes for, DEXTENZA; the development and regulatory status
of the Company’s product candidates, such as the Company’s regulatory
submissions for and the timing and conduct of, or implications of
results from, clinical trials of DEXTENZA for the treatment of
post-surgical ocular inflammation and the prospects for approvability of
DEXTENZA for post-surgical ocular inflammation or any other indications,
OTX-TP for the treatment of primary open-angle glaucoma and ocular
hypertension, OTX-TIC for the treatment of primary open-angle glaucoma
and ocular hypertension, OTX-TKI for the treatment of retinal diseases
including wet AMD, and OTX-IVT as an extended-delivery formulation of
the VEGF trap aflibercept for the treatment of retinal diseases
including wet AMD; the Company’s post-approval studies of ReSure Sealant
and the Company’s ongoing communications with the U.S. Food and Drug
Administration regarding the warning letter the Company received
regarding ReSure Sealant; the ongoing development of the Company’s
extended-delivery hydrogel depot technology; 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; 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, those related to 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 obtain 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 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 and need for additional financing 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 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 release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190501005569/en/
Source: Ocular Therapeutix, Inc.
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