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.
- All patients reported that the intracanalicular insert was comfortable.
- Ninety-six percent (96%) felt the insert was extremely or very convenient compared to topical eye drops on a tapered schedule.
- Ninety-two percent (92%) reported the highest level of overall product satisfaction, with eighty-eight percent (88%) saying they would request the insert if they were to undergo cataract surgery again.
- Ninety-two percent (92%) of patients surveyed said they would recommend DEXTENZA to friends or family members.
“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.
DEXTENZA™ (dexamethasone insert) 0.4mg for intracanalicular use 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 has completed three Phase 3 clinical trials with DEXTENZA for the treatment of post-surgical ocular inflammation and pain.
About Ocular Pain and Inflammation Following Ophthalmic Surgery
Ocular pain and inflammation are common side effects following ophthalmic surgery. Physicians prescribe topical corticosteroids as part of the standard of post-operative care. If left untreated, inflammation of the eye may result in further ocular complications, which in some cases may cause permanent loss of vision. According to US Census data, by the year 2020 it is estimated that the number of Americans diagnosed with cataracts is expected to rise to approximately 30 million, representing a 32% increase over current prevalence estimates.
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
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 our expectations regarding the NDA filed with the FDA and the FDA’s response to the resubmitted NDA, DEXTENZA for the treatment of allergic conjunctivitis, DEXTENZA for the treatment of inflammatory dry eye disease and OTX-TP for the treatment of glaucoma and ocular hypertension, the ongoing development of the Company’s sustained release hydrogel technology, the potential utility of any of the Company’s product candidates, potential commercialization of the Company’s product candidates, the potential benefits and future operation of the Company’s collaboration with Regeneron, including any potential future payments thereunder, the sufficiency of the Company’s cash resources and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of
Ocular Therapeutix, Inc.
Chief Financial Officer
Burns McClellan on behalf of Ocular Therapeutix
Steve Klass, 212-213-0006
Sandra Correa, 646-599-8637
Media and Business Group Director
Ocular Therapeutix, Inc.
Vice President of Marketing & Commercial Operations