Ocular Therapeutix™ Submits Supplemental New Drug Application (sNDA) for DEXTENZA® (dexamethasone ophthalmic insert) for the Treatment of Ocular Inflammation Following Ophthalmic Surgery
sNDA Expands the Current DEXTENZA® Post-Operative Pain Label as the First Intracanalicular Insert for Drug Delivery
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
“Submission of this sNDA on the heels of the initial DEXTENZA approval
is another significant milestone for
The sNDA is supported by the two previous Phase 3 clinical trials and
safety and efficacy data from an additional 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 were
recently published in the
In connection with the approval and anticipated commercial launch of
DEXTENZA, Ocular Therapeutix has also submitted an application to
Current DEXTENZA® Indication and Important Safety Information
DEXTENZA® (dexamethasone ophthalmic insert) is a corticosteroid indicated for the treatment of ocular pain following ophthalmic surgery.
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
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; 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
Senior Vice President, Commercial