|View printer-friendly version|
|New Publication Describes Positive Patient Experience in Study of Ocular Therapeutix’ DEXTENZA™ Following Cataract Surgery|
DEXTENZA is a hydrogel-based drug-eluting intracanalicular insert that
The goal associated with DEXTENZA is to reduce the patient burden of administration of topical eye drops following ophthalmic surgery by enabling the physician to control the entire course of steroid therapy with a single administration. The extended release benefit of DEXTENZA replaces the need for patients to administer steroid eye drops in a complex, tapering, several-times-a-day regimen over the course of a month. In parallel, DEXTENZA aims to remove the issues commonly associated with non-compliance of post-operative medications following ophthalmic surgery.
A New Drug Application (NDA) for DEXTENZA is currently under review by
The patient experience retrospective study was conducted with 25 patients who had received active treatment in the Company’s Phase 3 clinical trials of DEXTENZA for the treatment of post-surgical ocular pain and inflammation.
“We are encouraged by the experiences these patients shared, which add
another dimension to the clinical results achieved in the Phase 3
clinical trials,” said
In the Company’s third and most recent Phase 3 clinical trial, DEXTENZA successfully met the two primary efficacy endpoints, absence of ocular pain on day 8 and absence of ocular inflammation on day 14, when compared to placebo. DEXTENZA has exhibited a favorable safety profile and has been well tolerated in all clinical trials, regardless of indication. Subject to the approval of the NDA for post-surgical ocular pain by the FDA, Ocular Therapeutix intends to submit an NDA supplement for DEXTENZA to broaden its label to include a post-surgical inflammation indication.
About Ocular Pain and Inflammation Following Ophthalmic Surgery
According to Market Scope, approximately 3.9 million cataract cases and over 5.6 million ocular surgeries were performed in the United States in 2016.
About Ocular Therapeutix, Inc.
Forward Looking Statements