DEXTENZA® (dexamethasone ophthalmic insert) is
the First Intracanalicular Insert for Drug Delivery
Ocular Therapeutix to Host Conference Call
Today at 8:30 am ET
Subhead of release should read: DEXTENZA®
(dexamethasone ophthalmic insert) is the First Intracanalicular
Insert for Drug Delivery (instead of DEXTENZA® (dexamethasone
ophthalmic insert) is the First Intracanalicular Insert Approved by
the FDA for Drug Delivery).
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20181203005281/en/
The corrected release reads:
OCULAR THERAPEUTIX™ ANNOUNCES FDA APPROVAL
OF DEXTENZA® FOR THE TREATMENT OF OCULAR PAIN FOLLOWING
OPHTHALMIC SURGERY
DEXTENZA® (dexamethasone ophthalmic insert) is
the First Intracanalicular Insert for Drug Delivery
Ocular Therapeutix to Host Conference Call
Today at 8:30 am ET
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 that the U.S. Food and Drug
Administration (FDA) has approved DEXTENZA® (dexamethasone
ophthalmic insert) 0.4mg for intracanalicular use for the treatment
of ocular pain following ophthalmic surgery.
“We are extremely pleased to announce the approval of DEXTENZA,
coming so soon after our pre-approval inspection and approximately
one month ahead of the PDUFA date,” said Antony Mattessich, the
Company’s President and Chief Executive Officer. “Just over a year
ago, we set out to augment our scientific and formulation expertise
with individuals who have the skills and experience to create a
first-class team to get DEXTENZA approved and become a commercial
stage biopharmaceutical company. We believe this approval is a
major external validation of the drug delivery technology platform,
and also of the transformation that has taken place at Ocular.
While we are excited by the approval of our first drug product, our
goal has always been to bring DEXTENZA to as many patients as
possible in the near term and to revolutionize ophthalmic drug
delivery by making drops obsolete. We now turn our efforts towards
the successful commercial launch of DEXTENZA.”
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. The approval of DEXTENZA
was based on (i) demonstrated efficacy in two randomized,
vehicle-controlled Phase 3 studies in which a statistically
significantly higher incidence of subjects were pain free at day 8
post-cataract surgery compared to the vehicle control group and
(ii) safety in the two Phase 3 studies as well as a third
randomized, vehicle-controlled Phase 2 study. The Company believes
the delivery profile represents a differentiated and potentially
transformational new product for patients and physicians. For
patients, DEXTENZA offers the convenience of a full course of
post-surgical steroid treatment with a physician’s one-time
placement of a single intracanalicular insert. DEXTENZA has the
potential to replace a complex eye drop regimen that under the
current standard of care requires up to 70 topical ocular steroid
drops.
“Compliance with taking eye drops after eye surgery is very
challenging for patients and a concern for surgeons,” said Michael
Goldstein, MD, Chief Medical Officer. “The approval of DEXTENZA
offers surgeons the opportunity to treat patients with a
preservative-free steroid after surgery with the placement of a
single drug insert. With this product, patients may be liberated
from having to deal with the burdensome regimen of using steroid
eye drops after ophthalmic surgery.”
In connection with the commercial launch of DEXTENZA, Ocular
Therapeutix also submitted an application for transitional
pass-through payment status after receiving FDA approval and
intends to submit an application for a J-code ahead of the January
2019 deadline.
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 the approval of DEXTENZA. The live webcast can
be accessed by visiting the Investors 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 live conference call. The
conference ID number for the live call will be 2384369. An archive
of the webcast will be available until December 17, 2018 on
the Company’s website.
DEXTENZA® Label
DEXTENZA® (dexamethasone ophthalmic insert) is a corticosteroid
indicated for the treatment of ocular pain following ophthalmic
surgery.
DEXTENZA is a preservative-free ophthalmic insert that is
inserted in the lower lacrimal punctum and into the canaliculus. A
single DEXTENZA releases a 0.4 mg dose of dexamethasone for up to
30 days following insertion.
DEXTENZA is resorbable and does not require removal. Saline
irrigation or manual expression can be performed to remove the
insert if necessary. DEXTENZA is intended for single-use only.
DEXTENZA was studied in two randomized, multicenter,
double-masked, parallel group, vehicle-controlled Phase 3 clinical
trials, with patients receiving DEXTENZA or its vehicle immediately
upon completion of cataract surgery. In Study 1, 80% of
DEXTENZA-treated patients (n=164) were pain-free at Day 8 compared
to 43% of vehicle-treated patients (n=83) (p<0.0001). In Study
2, 77% of DEXTENZA-treated patients (n=161) were pain-free at Day 8
compared to 59% of vehicle-treated patients (n=80) (p=0.025).
Safety was assessed from the two Phase 3 clinical trials and a
Phase 2 clinical trial. Overall, 351 subjects were exposed to
DEXTENZA. The most common ocular adverse reactions 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%).
DEXTENZA® Important Safety Information
DEXTENZA is contraindicated in patients with active corneal,
conjunctival or canalicular infections, including epithelial herpes
simplex keratitis (dendritic keratitis), vaccinia, and varicella;
mycobacterial infections; fungal diseases of the eye; and
dacryocystitis.
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 and 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.
Please see Important Safety Information and Full Prescribing
Information at www.DEXTENZA.com
About DEXTENZA®
DEXTENZA® (dexamethasone ophthalmic insert) 0.4mg is FDA
approved for the treatment of ocular pain following ophthalmic
surgery. DEXTENZA is a corticosteroid intracanalicular insert
placed in the punctum, a natural opening in the inner portion of
the lower eyelid, and into the canaliculus and is designed to
deliver dexamethasone to the ocular surface for up to 30 days
without preservatives. DEXTENZA resorbs and exits the nasolacrimal
system without the need for removal.
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 ReSure Sealant, DEXTENZA® or any of the
Company’s product candidates, 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 expectations regarding its appeal of the warning letter
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 ReSure Sealant,
DEXTENZA or any product candidate that receives regulatory
approval, including the conduct of post-approval studies, the
ability to retain regulatory approval of ReSure Sealant, DEXTENZA
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 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.
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/20181203005281/en/
InvestorsOcular TherapeutixDonald NotmanChief Financial
Officerdnotman@ocutx.comorWestwicke PartnersChris BrinzeyManaging
Directorchris.brinzey@westwicke.comMediaOcular
TherapeutixScott CorningSenior Vice President,
Commercialscorning@ocutx.com
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