One outstanding item remains pertaining to manufacturing process
and controls
BEDFORD, Mass.--(BUSINESS WIRE)--Aug. 3, 2016--
Ocular Therapeutix, Inc. (NASDAQ: OCUL), a biopharmaceutical company
focused on the development and commercialization of innovative therapies
for diseases and conditions of the eye, today provided an update on the
status of its New Drug Application (NDA) for DEXTENZA™ (dexamethasone
insert) 0.4 mg, for intracanalicular use in the treatment of ocular pain
occurring after ophthalmic surgery.
On July 25, 2016, Ocular Therapeutix announced that it received a
Complete Response Letter (CRL) from the U.S. Food and Drug
Administration (FDA) regarding its NDA for DEXTENZA that identified
issues pertaining to deficiencies in the manufacturing process and
controls identified during a pre-NDA approval inspection of the
Company’s manufacturing facility. The CRL for DEXTENZA did not identify
any efficacy or safety concerns with respect to the clinical data
provided in the NDA nor any need for additional clinical trials for the
approval of the NDA.
Recently, the FDA issued a letter to Ocular Therapeutix noting that
corrective actions detailed in its responses as a whole appear to
address the ten inspectional observations raised in the Form FDA 483
with one exception which relates to the proposed process for identity
testing of an incoming inert gas component used in the manufacturing
process. In this letter, the FDA also requested that the Company provide
evidence (e.g., a final report) when migration to automatic integration
of analytical testing is complete, which is anticipated during the third
quarter of 2016.
“We are working closely with the FDA to address the one remaining item
and are planning for a resubmission to our NDA as soon as possible,”
said Amar Sawhney, Ph.D., President, Chief Executive Officer and
Chairman. “We remain committed to bringing DEXTENZA to market as rapidly
as possible.”
About DEXTENZA™
DEXTENZA (dexamethasone insert) is placed through the punctum, a natural
opening in the eye lid, into the canaliculus and is designed to deliver
dexamethasone to the ocular surface for up to 30 days. Following
treatment, DEXTENZA resorbs and exits the nasolacrimal system without
need for removal. The Company is pursuing multiple indications for
DEXTENZA, including the treatment of post-surgical ocular pain,
post-surgical ocular inflammation, ocular itching associated with
allergic conjunctivitis, as well as signs and symptoms associated with
inflammatory dry eye disease.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. (NASDAQ: OCUL) is a biopharmaceutical company
focused on the development and commercialization of innovative therapies
for diseases and conditions of the eye using its proprietary hydrogel
platform technology. Ocular Therapeutix's lead product candidate,
DEXTENZA™ (dexamethasone insert), is in Phase 3 clinical development for
post-surgical ocular inflammation and pain and allergic conjunctivitis,
and in Phase 2 clinical development for dry eye disease. A third Phase 3
clinical trial is being conducted for post-surgical ocular inflammation
and pain. For glaucoma and ocular hypertension, the Company plans to
initiate the first of two OTX-TP (sustained release travoprost) Phase 3
clinical trials in the third quarter of 2016. Ocular Therapeutix is also
evaluating sustained-release injectable anti-VEGF drug depots for
back-of-the-eye diseases. Ocular Therapeutix's first product, ReSure®
Sealant, is FDA-approved to seal corneal incisions following cataract
surgery.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160803006579/en/
Source: Ocular Therapeutix, Inc.
Investors
Ocular Therapeutix, Inc.
Brad Smith
Chief
Financial Officer
bsmith@ocutx.com
or
Burns
McClellan on behalf of Ocular Therapeutix
Steve Klass, 212-213-0006
sklass@burnsmc.com
or
Media
Ocular
Therapeutix, Inc.
Scott Corning
Vice President of Sales and
Marketing
scorning@ocutx.com
