DEXTENZA® (dexamethasone ophthalmic insert) is the First
Intracanalicular Insert for Drug Delivery
Ocular Therapeutix to Host Conference Call Today at 8:30 am ET
BEDFORD, Mass.--(BUSINESS WIRE)--Dec. 3, 2018--
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.
This press release features multimedia. View the full release here:
“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
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
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
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
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/
Source: Ocular Therapeutix™, Inc.
Senior Vice President, Commercial