Press Release
Ocular Therapeutix™ Announces FDA Acceptance of NDA Filing for DEXTENZA™ for the Treatment of Post-Surgical Ocular Pain
PDUFA target action date of
DEXTENZA initial target indication comprises over 5 million ocular surgeries
“We are pleased that Ocular Therapeutix’s first NDA filing with our lead
product candidate, DEXTENZA, has been officially accepted for review by
the
The data included in the NDA are from a Phase 2 clinical trial and two
Phase 3 clinical trials conducted with DEXTENZA for the treatment of
post-surgical ocular inflammation and pain. Based on the results of
these trials and following a Pre-NDA Clinical meeting with the
“DEXTENZA is designed to give a patient an entire 30-day course of
medication with a single application of a depot, placed by the doctor in
the tear punctum. Patients don't have to take the medication themselves,
and doctors don't have to wonder whether patients are being compliant.
This is a novel development in ophthalmology. It is also exciting to
consider the additional possibilities the company is pursuing for
DEXTENZA, as a one-time use steroid with a strong safety profile that
could have broad applicability in ophthalmology,” stated
About DEXTENZATM
DEXTENZA (sustained release dexamethasone) Intracanalicular Depot is placed through the punctum, a natural opening in the eyelid, into the canaliculus and is designed to deliver dexamethasone to the ocular surface for four weeks. Following treatment, DEXTENZA resorbs and exits the nasolacrimal system without need for removal. To capitalize on the broader opportunity for the sustained delivery of corticosteroids to the front of the eye, the Company is pursuing multiple indications for DEXTENZA. These include treatment of:
- post-surgical ocular pain
- post-surgical ocular inflammation
- ocular itching associated with allergic conjunctivitis
- signs and symptoms associated with inflammatory dry eye disease
In addition to the NDA submission for the treatment of ocular pain following ophthalmic surgery, the Company has recently initiated a third Phase 3 clinical trial for post-surgical ocular inflammation and pain. The Company also recently completed its first Phase 3 clinical trial for allergic conjunctivitis and reported that DEXTENZA successfully met the primary endpoint for the treatment of ocular itching associated with allergic conjunctivitis, and recently initiated a second Phase 3 clinical trial for this indication. Subject to approval of the NDA for post-surgical pain and subject to obtaining favorable results for the Phase 3 trial of DEXTENZA for post-surgical ocular inflammation and pain, the Company intends to submit supplements to the NDA for the treatment of post-surgical inflammation, as well as for itching associated with allergic conjunctivitis, to seek to broaden DEXTENZA’s label.
The Company has also completed patient enrollment in an exploratory Phase 2 clinical trial of DEXTENZA for the treatment of inflammatory dry eye and expects to report topline efficacy data from this trial in December of 2015.
About Post-Surgical Ocular Inflammation and Pain
Ocular pain and inflammation are common side effects following
ophthalmic surgery. Physicians prescribe anti-inflammatory drugs, such
as corticosteroids, as the standard of care following ophthalmic
surgery. If left untreated, inflammation of the eye may result in
further ocular complications, including scarring and vision loss.
Approximately 5.3 million ocular surgeries were performed in
About Ocular Therapeutix, Inc.
Forward Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company, including statements about the
development or potential commercialization of the Company’s product
candidates, such as the Company’s plans and expectations regarding
regulatory submissions and the design and conduct of a third Phase 3
clinical trial of DEXTENZA™ for post-surgical inflammation and pain, the
timing and conduct of a second Phase 3 clinical trial of DEXTENZA for
the treatment of allergic conjunctivitis, the Company’s exploratory
Phase 2 clinical trial of DEXTENZA for the treatment of inflammatory dry
eye disease, the timing and conduct of the Company’s additional
development work and clinical trials of OTX-TP for the treatment of
glaucoma and ocular hypertension and the ongoing development of the
Company’s sustained release hydrogel depot technology, the advancement
of the Company's other product candidates, the potential utility of any
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, 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
View source version on businesswire.com: http://www.businesswire.com/news/home/20151209005645/en/
Source:
Investors
Ocular Therapeutix, Inc.
Brad Smith
Chief
Financial Officer
bsmith@ocutx.com
or
Burns
McClellan on behalf of Ocular Therapeutix
Kimberly Minarovich,
212-213-0006
kminarovich@burnsmc.com
or
Media
Ocular
Therapeutix, Inc.
Scott Corning
Vice President of Sales and
Marketing
scorning@ocutx.com