Ocular Therapeutix, Inc., a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced that the U.S. Food and Drug Administration (FDA) has approved Dextenza (dexamethasone ophthalmic insert) 0.4mg for intracanalicular use for the treatment of ocular pain following ophthalmic surgery.
Dextenza is the first FDA-approved intracanalicular insert delivering dexamethasone to treat post-surgical ocular pain for up to 30 days with a single administration. The approval of Dextenza was based on demonstrated efficacy in two randomized, vehicle-controlled Phase 3 studies in which a statistically significantly higher incidence of subjects were pain free at day 8 post-cataract surgery compared to the vehicle control group and safety in the two Phase 3 studies as well as a third randomized, vehicle-controlled Phase 2 study.
The company believes the delivery profile represents a differentiated and potentially transformational new product for patients and physicians. For patients, Dextenza offers the convenience of a full course of post-surgical steroid treatment with a physician’s one-time placement of a single intracanalicular insert.
Dextenza has the potential to replace a complex eye drop regimen that under the current standard of care requires up to 70 topical ocular steroid drops.
“Compliance with taking eye drops after eye surgery is very challenging for patients and a concern for surgeons,” said Michael Goldstein, M.D., chief medical officer. “The approval of Dextenza offers surgeons the opportunity to treat patients with a preservative-free steroid after surgery with the placement of a single drug insert. With this product, patients may be liberated from having to deal with the burdensome regimen of using steroid eye drops after ophthalmic surgery.”
In connection with the commercial launch of Dextenza, Ocular Therapeutix also submitted an application for transitional pass-through payment status after receiving FDA approval and intends to submit an application for a J-code ahead of the January 2019 deadline.
(Source: Ocular Therapeutix, Inc.)