Ocular Therapeutix™ Announces Successful Resolution of FDA Warning Letter Related to ReSure® Sealant
September 08 2020 - 7:00AM
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, announced it has received a letter from the
U.S. Food and Drug Administration (FDA) dated September 2, 2020
closing out the Warning Letter it received from the FDA on October
18, 2018 concerning ReSure® Sealant. The violation cited in Warning
Letter (CMS #564663) has been addressed and Ocular is committed to
sustained compliance with all federal regulations.
“We are very excited to have cleared the way for ReSure’s
future” said Antony Mattessich, President and Chief Executive
Officer of Ocular Therapeutics. ”ReSure is well-regraded by
anterior segment surgeons and fits perfectly into the bag with
Dextenza. This resolution gives us the confidence to begin active
promotion of ReSure and realize the synergies of a two-product
field force.”
The Warning Letter was issued to Ocular based on the observed
inability to conduct a study evaluating endophthalmitis rates
following ReSure use in a post-approval Device Exposure Registry
study required under 21 CFR 814.82(a)(2) as a condition within the
premarket approval (PMA) application. It was determined the ability
to enroll a study evaluating endophthalmitis rates was
prohibitively challenging due to the size of the study that would
have required tens of thousands of patients. Ocular has come to an
agreement with the FDA to conduct a retrospective study looking at
sites with access to ReSure compared to those without access to
ReSure using the American Academy of Ophthamology’s Iris Registry
data base.
About ReSure® Sealant
ReSure Sealant, a hydrogel ophthalmic wound medical device, is a
product currently indicated for intraoperative management of clear
corneal incisions (up to 3.5mm) with a demonstrated wound leak for
which a temporary dry surface can be achieved, in order to prevent
postoperative fluid egress from such incisions following cataract
surgery with intraocular lens placement in adults.
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 inflammation
and pain following ophthalmic surgery. Ocular Therapeutix recently
completed a Phase 3 clinical trial evaluating DEXTENZA for the
treatment of ocular itching associated with allergic
conjunctivitis. The Company’s earlier stage development assets
currently in Phase 1 trials include OTX-TIC (travoprost
intracameral implant) for the reduction of intraocular pressure in
patients with primary open-angle glaucoma and ocular hypertension,
OTX-CSI (cyclosporine intracanalicular insert) for the treatment of
the signs and symptoms of dry eye disease and OTX-TKI (axitinib
intravitreal implant) for the treatment of retinal diseases. Also,
Ocular Therapeutix is currently developing OTX-DED (dexamethasone
intracanalicular insert) for the treatment of episodic dry eye and,
in collaboration with Regeneron, OTX-AFS (aflibercept
suprachoroidal injection) for an extended-delivery formulation of
aflibercept for the treatment of retinal diseases, and 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; the commercial launch of, and
effectiveness of reimbursement codes for, 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 treatment of episodic dry eye
disease, OTX-CSI for the treatment of dry eye disease, 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-AFS 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 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; 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, the 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 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/20200908005367/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 Aug 2024 to Sep 2024
Ocular Therapeutix (NASDAQ:OCUL)
Historical Stock Chart
From Sep 2023 to Sep 2024