Ocular Therapeutix, a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative therapies for diseases and conditions of the eye, has announced positive results of a patient experience study of Dextenza (dexamethasone insert) 0.4mg for intracanalicular use. The study, published in Patient Preference and Adherence, evaluated the overall patient experience and perceived value of Dextenza following cataract surgery.
Dextenza is a hydrogel-based drug-eluting intracanalicular insert that incorporates the FDA-approved corticosteroid, dexamethasone, as the active ingredient. Inserted non-invasively through the punctum, Dextenza resides within the canaliculus and delivers dexamethasone to the ocular surface for approximately 30 days. Following the completion of treatment, Dextenza resorbs and exits the nasolacrimal system without need for removal.
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 FDA for the treatment of ocular pain occurring after ophthalmic surgery. The FDA has set a PDUFA target action date for July 19, 2017.
The patient experience retrospective study was conducted with 25 patients who had received active treatment in the company’s phase III clinical trials of Dextenza for the treatment of post-surgical ocular pain and inflammation.
All patients reported that the intracanalicular insert was comfortable.
“We are encouraged by the experiences these patients shared, which add another dimension to the clinical results achieved in the phase III clinical trials,” said Jonathan H. Talamo, M.D., chief medical officer of Ocular Therapeutix. “If approved, we believe that Dextenza, which incorporates the Company’s proprietary hydrogel platform technology, will offer an attractive alternative to the current post-operative standard of care of steroid eye drops for those recovering from ophthalmic surgery.”
In the company’s third and most recent phase III clinical trial, Dextenza successfully met the two primary efficacy endpoints, absence of ocular pain on day eight 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.