PDUFA Target Action Date Set for November 10, 2019
BEDFORD, Mass.--(BUSINESS WIRE)--Apr. 2, 2019--
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, today
announced the U.S. Food and Drug Administrations (FDA) has accepted for
filing the supplemental New Drug Application (sNDA) for DEXTENZA®
(dexamethasone ophthalmic insert) to include the treatment of ocular
inflammation following ophthalmic surgery in its label. The notice of
acceptance confirms the FDA has completed its initial review of the
filing and has determined that the sNDA is sufficiently complete to
permit formal review. The FDA has set a Prescription Drug User Fee Act
(PDUFA) target action date of November 10, 2019 for its review of the
sNDA.
DEXTENZA is the first FDA-approved intracanalicular insert delivering
dexamethasone to treat post-surgical ocular pain for up to 30 days with
a single administration. DEXTENZA received FDA approval in November 2018
for the treatment of ocular pain following ophthalmic surgery. DEXTENZA
is a resorbable, preservative-free ophthalmic insert that is placed in
the lower lacrimal punctum and into the canaliculus of the eye.
The sNDA application to include inflammation [following ophthalmic
surgery] is supported by the two Phase 3 clinical trials used to obtain
the pain approval and safety and efficacy data from a third prospective,
multicenter, randomized, controlled Phase 3 clinical trial of DEXTENZA
(n=438) in cataract surgery patients that demonstrated statistical
significance compared to the vehicle control for the endpoints of
absence of ocular pain (p<0.0001) and absence of inflammation
(p<0.0001). The ocular safety profile was similar to that demonstrated
in the two prior Phase 3 clinical trials. Data from the third Phase 3
clinical trial was recently published in the Journal of Cataract &
Refractive Surgery (JCRS) in February 2019.
Current DEXTENZA Indication and Important Safety Information
DEXTENZA (dexamethasone ophthalmic insert) is a corticosteroid indicated
for the treatment of ocular pain following ophthalmic surgery.
CONTRAINDICATIONS
DEXTENZA is contraindicated in patients with
active corneal, conjunctival or canalicular infections, including
epithelial herpes simplex keratitis (dendritic keratitis), vaccinia,
varicella; mycobacterial infections; fungal diseases of the eye, and
dacryocystitis.
WARNINGS AND PRECAUTIONS
Prolonged use of corticosteroids may
result in glaucoma with damage to the optic nerve, defects in visual
acuity and fields of vision. Steroids should be used with caution in the
presence of glaucoma. Intraocular pressure should be monitored during
treatment.
Corticosteroids may suppress the host response and thus increase the
hazard for secondary ocular infections. In acute purulent conditions,
steroids may mask infection and enhance existing infection.
Use of ocular steroids may prolong the course and may exacerbate the
severity of many viral infections of the eye (including herpes simplex).
Fungus invasion must be considered in any persistent corneal ulceration
where a steroid has been used or is in use. Fungal culture should be
taken when appropriate.
Use of steroids after cataract surgery may delay healing and increase
the incidence of bleb formation.
ADVERSE REACTIONS
The most common ocular adverse reactions that
occurred in subjects treated with DEXTENZA were: anterior chamber
inflammation including iritis and iridocyclitis (9%); increased
intraocular pressure (5%); reduced visual acuity (2%); eye pain (1%);
cystoid macular edema (1%); corneal edema (1%); and conjunctival
hyperemia (1%). The most common non-ocular adverse event was headache
(1%).
Please see full Prescribing Information at www.DEXTENZA.com
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 pain
following ophthalmic surgery. OTX-TP (intracanalicular travoprost
insert) is an intracanalicular insert in Phase 3 clinical development
for the reduction of intraocular pressure in patients with primary
open-angle glaucoma and ocular hypertension. The Company’s earlier stage
assets include OTX-TIC, an extended-delivery intracameral travoprost
implant for the reduction of intraocular pressure in patients with
glaucoma and ocular hypertension, as well as sustained release
intravitreal implants for the treatment of retinal diseases. These
intravitreal implants include OTX-TKI, containing a tyrosine kinase
inhibitor (TKI), and, in collaboration with Regeneron, OTX-IVT, an
extended-delivery protein-based anti-vascular endothelial growth factor
(VEGF) trap. 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 development and regulatory status
of the Company’s product candidates, such as the Company’s regulatory
submissions for and the timing and conduct of, or implications of
results from, clinical trials of DEXTENZA for the treatment of
post-surgical ocular inflammation and the prospects for approvability of
DEXTENZA for post-surgical ocular inflammation or any other indications,
OTX-TP for the treatment of primary open-angle glaucoma and ocular
hypertension, 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-IVT as an extended-delivery formulation of
the VEGF trap aflibercept for the treatment of retinal diseases
including wet AMD; the Company’s post-approval studies of ReSure®
Sealant and the Company’s ongoing communications with the U.S. Food and
Drug Administration regarding the warning letter the Company received
regarding ReSure Sealant; the ongoing development of the Company’s
extended-delivery hydrogel depot technology; 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; 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 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
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 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 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 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 release.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190402005596/en/
Source: Ocular Therapeutix
Investors
Ocular Therapeutix
Donald Notman
Chief
Financial Officer
dnotman@ocutx.com
or
Westwicke,
an ICR Company
Chris Brinzey
Managing Director
chris.brinzey@westwicke.com
Media
Ocular
Therapeutix
Scott Corning
Senior Vice President, Commercial
scorning@ocutx.com
