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
BEDFORD, Mass.--(BUSINESS WIRE)--Oct. 13, 2016--
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/
Source: Ocular Therapeutix, Inc.
Investors
Ocular Therapeutix, Inc.
Brad Smith
Chief
Financial Officer
bsmith@ocutx.com
or
Burns
McClellan on behalf of Ocular Therapeutix
Steve Klass, 212-213-0006
sklass@burnsmc.com
or
Media
Ocular
Therapeutix, Inc.
Scott Corning
Vice President of Sales and
Marketing
scorning@ocutx.com