Press Release
Ocular Therapeutix™ Announces Notification of FDA Acceptance of Supplemental New Drug Submission for DEXTENZA® (dexamethasone ophthalmic insert) for the Treatment of Ocular Inflammation Following Ophthalmic Surgery
PDUFA Target Action Date Set for
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
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
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
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20190402005596/en/
Source:
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