New Strategic Collaboration with Regeneron to
Develop Sustained Release Formulation of Aflibercept for the
Treatment of Wet AMD and Other Serious Retinal Diseases
Ocular Therapeutix Selected to Present Retinal
Program Progress during Posterior Segment Company Showcase at the
2016 Ophthalmology Innovation Summit (OIS)
Company to Host Conference Call Today at 8:30
am Eastern Time
Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical
company focused on the development and commercialization of
innovative therapies for diseases and conditions of the eye, today
provided an update on the Company’s development strategy for its
sustained release intravitreal depot technology for the treatment
of serious retinal diseases.
The Company is currently developing proprietary
sustained-release hydrogel-based drug delivery depots for
intravitreal injection that can be formulated with both small and
large molecule pharmaceuticals, such as tyrosine kinase inhibitors
(TKIs) and protein-based anti-vascular endothelial growth factors
(VEGFs) respectively, with the goal of delivering sustained and
therapeutic levels of drugs to targeted ocular tissues. The goal of
the Company’s intravitreal depot dual development program is to
reduce the frequency of injections that are currently the standard
of care for the treatment of wet AMD, DME and other retinal
diseases.
Accordingly, Ocular Therapeutix also announced today that it has
entered into a strategic collaboration, option and license
agreement with Regeneron Pharmaceuticals for the development of a
sustained release formulation of Regeneron’s VEGF trap,
aflibercept, for the treatment of wet age-related macular
degeneration (wet AMD) and other serious retinal diseases.
Regeneron’s aflibercept is currently approved by the U.S. Food and
Drug Administration (FDA) for certain indications under the brand
name EYLEA®. Per the agreement, Ocular Therapeutix retains all
rights to develop its sustained-release hydrogel-based drug
delivery platform with all other non-VEGF targeting compounds as
well as with small molecule pharmaceuticals, including TKIs, for
other retinal diseases.
“In preclinical studies completed to date, we have demonstrated
up to 6 months of sustained release of anti-VEGF drugs using our
hydrogel-based drug delivery technology with a good safety
profile,” stated Dr. Jon Talamo, Chief Medical Officer of Ocular
Therapeutix. “A 4-6-month sustained release formulation has the
potential to advance the current standard of care in wet AMD and
other retinal diseases by significantly reducing injection
frequency. We have also demonstrated minimal inflammatory response
in vivo through 26 weeks with both our anti-VEGF protein and TKI
depots currently in development. This technology represents an
exciting development in the field of ophthalmology and we look
forward to further advancing these programs.”
Presentation at 2016 Ophthalmology Innovation Summit
(OIS)
Ocular Therapeutix has been selected to present during the
Posterior Segment Company Showcase at the 2016 Ophthalmology
Innovation Summit (OIS). Dr. Amar Sawhney, President, Chief
Executive Officer and Chairman, will provide an overview of recent
progress from the Company’s ongoing intravitreal depot development
programs today, October 13, 2016 at 11:42am CDT at the Hyatt
Regency Chicago Hotel in Chicago, Illinois.
Commonly referred to as OIS@AAO, the summit is held each year in
conjunction with the American Academy of Ophthalmology (AAO) Annual
Meeting.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will host a
live conference call and webcast today at 8:30 am Eastern Time to
discuss recent progress from the Company's intravitreal depot
development programs, as well as the collaboration with Regeneron,
which was also announced this morning.
The live webcast and accompanying slide presentation can be
accessed by visiting the investor section of the Company’s website
at investors.ocutx.com. Please connect at least 15 minutes prior to
the live webcast to ensure adequate time for any software download
that may be needed to access the webcast. Alternatively, please
call 844-464-3934 (U.S.) or 765-507-2620 (International) to listen
to the conference call. The conference ID number for the live call
will be 98223266. An archive of the webcast will be available until
October 27, 2016 on the Company’s website.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. (NASDAQ: OCUL) is a biopharmaceutical
company focused on the development and commercialization of
innovative therapies for diseases and conditions of the eye using
its proprietary hydrogel platform technology. Ocular Therapeutix
has submitted an NDA for post-surgical pain for its lead product
candidate, DEXTENZA™ (dexamethasone insert, extended release),
which is in Phase 3 clinical development for post-surgical ocular
inflammation and pain and allergic conjunctivitis, and in Phase 2
clinical development for dry eye disease. OTX-TP (sustained release
travoprost) is in Phase 3 clinical development for glaucoma and
ocular hypertension. Ocular Therapeutix is also evaluating
sustained-release injectable drug depots for back-of-the-eye
diseases. Ocular Therapeutix's first product, ReSure® Sealant, is
FDA-approved to seal corneal incisions following cataract surgery.
For additional information about the Company, please visit
www.ocutx.com.
Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for the Company, including statements about the
potential benefits and future operation of the collaboration with
Regeneron, including any potential future payments thereunder, the
ongoing development of the Company’s sustained release hydrogel
depot technology, the development and regulatory status of the
Company’s other product candidates, such as the Company’s
expectations and plans regarding regulatory submissions for and the
timing and conduct of clinical trials of DEXTENZA™ for
post-surgical ocular inflammation and pain, including our
expectations regarding the NDA filed with the FDA, DEXTENZA for the
treatment of allergic conjunctivitis, DEXTENZA for dry eye disease
and OTX-TP for the treatment of glaucoma and ocular hypertension,
the potential utility of any of the Company’s product candidates,
potential commercialization of the Company’s product candidates,
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 ReSure® Sealant or any
product candidate that receives regulatory approval, the initiation
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 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. 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: http://www.businesswire.com/news/home/20161013005461/en/
InvestorsOcular Therapeutix, Inc.Brad SmithChief
Financial Officerbsmith@ocutx.comorBurns McClellan on behalf of
Ocular TherapeutixSteve Klass,
212-213-0006sklass@burnsmc.comorMediaOcular Therapeutix,
Inc.Scott CorningVice President of Sales and
Marketingscorning@ocutx.com
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