Full Press Release Details
Ocular Therapeutix Reports
Fourth Quarter and Year End 2019 Financial Results and Business Update
Fourth Quarter DEXTENZA Net Product
Revenue of $1.6 million, a 433% Sequential Increase; Guiding First Quarter Total Net Product Revenue of $3.0 million to $3.2 million
Presented Interim Clinical Data Releases
for OTX-TIC and OTX-TKI Showing Favorable Safety Profile, Tolerability, Durability and Early Biological Activity
BEDFORD, Mass. -(BUSINESS WIRE)-March 12, 2020-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 financial results for the fourth quarter and year
ended December 31, 2019 and provided a business update.
has had an impressive final quarter of 2019 and strong start to 2020," said Antony Mattessich, President and Chief Executive
Officer. "Key performance indicators on the launch of DEXTENZA point to a building momentum, most notably in the number of
billable inserts ordered by ASC's and hospitals that show a definitive acceleration. We are equally excited on the product
development side by interim results from our two Phase 1 programs: in our OTX-TIC program, signals support the possibility for
a product that could have both the magnitude and duration of effect to become a standard of care in the treatment of elevated IOP;
and, most encouragingly, in our OTX-TKI program, we have seen a signal of biologic effect, observing a reduction in sub-retinal
and intra-retinal fluid in some patients with wet AMD. Both of these early programs have the potential to shift current treatment
DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg
DEXTENZA is an FDA-approved corticosteroid indicated for the
treatment of ocular inflammation and pain following ophthalmic surgery.
OTX-TIC (travoprost implant for intracameral injection)
OTX-TIC is a long-acting travoprost intracameral implant for
the treatment of patients with primary open angle glaucoma or ocular hypertension. The Company presented interim data on OTX-TIC
at the Glaucoma 360 Conference held in San Francisco, CA in February.
OTX-TKI (tyrosine kinase inhibitor intravitreal implant
containing axitinib)
The Company announced
interim results last week from a Phase 1 clinical trial for OTX-TKI, a bioresorbable, hydrogel implant with anti-angiogenic properties
delivered by intravitreal injection to the posterior segment of the eye for wet age-related macular degeneration (wet AMD) and
other retinal diseases.
OTX-CSI (cyclosporine intracanalicular insert)
The Company recently filed an IND and intends to begin a Phase
1 clinical trial by the middle of 2020 for OTX-CSI, a cyclosporine intracanalicular insert targeting dry eye disease.
Fourth Quarter and Year Ended December 31, 2019 Financial
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will
host a live conference call and webcast today at 4:30 pm Eastern Time to review the Company's financial results and provide
a general business update. 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 9974763. An archive of the webcast will
be available until June 10, 2020 on the Company's website.
About DEXTENZA (dexamethasone ophthalmic insert) 0.4
DEXTENZA is an FDA-approved corticosteroid indicated for the
treatment of ocular inflammation and pain following ophthalmic surgery. DEXTENZA is inserted in the lower lacrimal punctum and
into the canaliculus by the physician following ophthalmic surgery. A single DEXTENZA releases a 0.4 mg dose of dexamethasone
for up to 30 days following insertion. DEXTENZA is preservative free, resorbable and does not require removal.
DEXTENZA is contraindicated in patients with active corneal,
conjunctival or canalicular infections. 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 the course of the treatment. Corticosteroids may suppress the host response to, and increase the hazard
for and severity of, secondary bacterial, viral, or fungal infections. The use of steroids after cataract surgery may delay wound
healing and increase the incidence of bleb formation.
The most commonly reported ocular adverse reactions that occurred
in patients treated with DEXTENZA were anterior chamber inflammation including iritis and iridocyclitis (10%) and elevations in
intraocular pressure (6%). The most common non-ocular adverse reaction was headache (1%).
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 inflammation and pain following ophthalmic surgery. Ocular Therapeutix is conducting
a Phase 3 clinical trial evaluating DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis. OTX-TP
(intracanalicular travoprost insert) is an intracanalicular insert in 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 commercial launch of, and effectiveness of reimbursement codes for, DEXTENZA;
the development and regulatory status of the Company's product candidates, such as the Company's development of
and prospects for approvability of DEXTENZA for additional indications including allergic conjunctivitis, 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 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; projected net product revenue; 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, 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 ability to maintain reimbursement codes for DEXTENZA, 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 Company's ability to generate its projected net product revenue on the timeline expected, if at all,
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