Ocular Therapeutix™ Receives Complete Response Letter from FDA for DEXTENZA™ NDA
Outstanding items pertain to Form FDA-483 close-out of manufacturing deficiencies and analytical testing
No efficacy or safety issues raised by
The CRL from the
The CRL acknowledges receipt of the Company’s NDA amendment dated
Satisfactory resolution of the manufacturing deficiencies detailed in the Form FDA-483 is required before the NDA may be approved. The FDA’s letter did not identify any efficacy or safety concerns with respect to the clinical data for DEXTENZA provided in the NDA nor any need for additional clinical trials for the NDA approval.
“We are evaluating the FDA’s response and plan to work closely with the
agency in an effort to satisfy the requirements related to the NDA,”
About DEXTENZA™ (dexamethasone insert) 0.4 mg for Intracanalicular Use
DEXTENZA is placed through the punctum, a natural opening in the eye lid, into the canaliculus and is designed to deliver dexamethasone without preservatives to the ocular surface for up to 30 days. Following treatment, DEXTENZA resorbs and exits the nasolacrimal system without need for removal.
About Ocular Therapeutix, Inc.
Forward Looking Statements
Any statements in this press release about future expectations, plans
and prospects for the Company including the development and regulatory
status of the Company’s product candidates, such as the Company’s
expectations and plans regarding regulatory submissions for and the
timing and conduct of clinical trials of DEXTENZA for the treatment of
post-surgical ocular inflammation and pain, including with respect to
the manufacturing deficiencies identified by the
Steve Klass, 212-213-0006
Interim Chief Financial Officer
Stephanie Eisenstat, 646-599-8627
Vice President of Marketing & Commercial Operations