BEDFORD, Mass.--(BUSINESS WIRE)--Ocular Therapeutix™, Inc. (NASDAQ: OCUL), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative therapies for diseases and conditions of the eye, today announced the appointment of Daniel Bollag, Ph.D., as Senior Vice President, Regulatory Affairs, Pharmacovigilance and Quality, effective immediately. In his role, Mr. Bollag will be responsible for leading and optimizing the Company’s strategic regulatory efforts, quality system and process controls.
“We are excited a professional of Dan’s caliber will be joining us at Ocular,” said Antony Mattessich, Chief Executive Officer of Ocular Therapeutix. “Dan brings a proven track record of complex global regulatory management and accomplishments in both large and small pharmaceutical company settings. He is a key part of our evolution into a true biopharmaceutical company. Dan’s expertise will be critical as we work towards resubmitting our new drug application (NDA) for DEXTENZA™ while continuing to advance our additional development programs.”
Dr. Bollag brings over 25 years of R&D and executive regulatory leadership experience to Ocular Therapeutix, having most recently served as Senior Vice President of Regulatory Affairs, Pharmacovigilance & Quality at Ariad Pharmaceuticals. During his tenure at Ariad, his responsibilities included the regulatory oversight of Iclusig® (ponatinib), from Phase 1 clinical development through accelerated approvals in the US, EU and Japan. Prior to joining Ariad, Dr. Bollag served as Vice President of Regulatory Affairs at Genzyme where he led the global development team responsible for regulatory submissions and approval of Mozobil®. Before Genzyme, Dr. Bollag served as Associate Vice President and Global Regulatory Domain Head at Sanofi-Aventis and held regulatory and project management positions of increasing responsibility at Bristol-Myers Squibb and Merck & Co.
Eric Ankerud, Executive Vice President, Regulatory, Quality and Compliance, will transition out of his current role and remain with the Company as a Senior Advisor and consultant as he devotes additional time to building his business consulting practice. Mr. Ankerud will continue to provide Ocular Therapeutix with his time, input, and expertise to facilitate the transition as the Company executes on its plan to resubmit the NDA for DEXTENZA.
“We would like to thank Eric for his many contributions to Ocular Therapeutix as a member of our executive team over the last 10 years,” stated Amar Sawhney, Ph.D., Executive Chairman. “We are pleased Eric will continue to advise the Company in a consulting role and believe Dr. Bollag’s appointment will further strengthen our regulatory and quality teams, leaving Ocular well-positioned to advance its broad portfolio of product candidates that have the potential to improve outcomes for patients with diseases and conditions of the eye.”
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc.
is a biopharmaceutical company focused on the development, manufacturing
and commercialization of innovative therapies for diseases and
conditions of the eye using its proprietary hydrogel platform
technology. Ocular Therapeutix’s lead product candidate, DEXTENZA™
(dexamethasone insert) 0.4 mg for intracanalicular use has completed
Phase 3 clinical development for the treatment of ocular pain and
inflammation following ophthalmic surgery. OTX-TP (travoprost insert) is
in Phase 3 clinical development for glaucoma and ocular hypertension.
Ocular Therapeutix is also evaluating injectable drug delivery depots
for back-of-the-eye diseases. 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 development and regulatory status of the Company’s product
candidates, such as the Company’s expectations and plans regarding
product development efforts and regulatory submissions for and the
timing and conduct of clinical trials of DEXTENZA for the treatment of
post-surgical ocular inflammation and pain and OTX-TP for the treatment
of glaucoma and ocular hypertension, the ongoing development of the
Company’s sustained release intravitreal depot technology, the potential
utility of any of the Company’s product candidates, potential
commercialization of the Company’s product candidates, 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 manufacturing
operations, the Company’s scientific approach and general development
progress, the availability or commercial potential of the Company’s
product candidates, the availability 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.