BEDFORD, Mass.--(BUSINESS WIRE)--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 the Centers for Medicare and Medicaid Services (CMS) has approved transitional pass-through payment status and established a new reimbursement code for DEXTENZA® (dexamethasone ophthalmic insert). The code, C9048, is scheduled to become effective July 1, 2019.
“We are pleased to receive pass-through payment status and assignment of a new C-code for DEXTENZA which physicians and their practices may use for reimbursement of the product,” said Antony Mattessich, President and Chief Executive Officer. “With sample product available and insertion training sessions already underway, the receipt of the C-code is another important step in the commercial launch of DEXTENZA.”
A C-code is a unique temporary product code established by CMS for the Hospital Outpatient Prospective Payment System (OPPS) used to report claims for hospital outpatient department and ambulatory surgical center services and procedures. The formal receipt of the C-code facilitates the reimbursement of DEXTENZA until such time as CMS may potentially approve a J-code and such approval becomes effective. In May 2019, the Company announced that CMS has included DEXTENZA on its list of products that have been preliminarily recommended for a new dedicated Healthcare Common Procedure Coding System (HCPCS) J-code which, if granted, would become effective January 1, 2020. A J-code represents a permanent product code that could be used across settings of care.
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 receipt and effectiveness 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 the approvability of, and discussions with regulatory
authorities regarding, 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 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 and 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 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.