Ocular Therapeutix (NSDQ:OCUL) said today that the FDA approved its resubmitted application Dextenza, an ocular insert designed to release dexamethasone to relieve pain following ophthalmic surgery.
The regulatory win for the Bedford, Mass.-based company comes after much back-and-forth with the FDA; the agency has twice rejected Ocular Therapeutix’s application for Dextenza.
The company’s device is designed to deliver drugs for up to 30 days following treatment in a physician’s office. Ocular Therapeutix is positioning its product as a way to eliminate the current standard of care for post-surgical pain – topical steroid eye drops.
Ocular Therapeutix also reported today that it submitted an application for transitional pass-through payment status following FDA approval and hopes to submit for a J-code ahead of the Jan. 2019 deadline.
“We are extremely pleased to announce the approval of Dextenza, coming so soon after our pre-approval inspection and approximately one month ahead of the PDUFA date,” president & CEO Antony Mattessich said in prepared remarks. “Just over a year ago, we set out to augment our scientific and formulation expertise with individuals who have the skills and experience to create a first-class team to get Dextenza approved and become a commercial-stage biopharmaceutical company. We believe this approval is a major external validation of the drug delivery technology platform, and also of the transformation that has taken place at Ocular.”
“Compliance with taking eye drops after eye surgery is very challenging for patients and a concern for surgeons,” CMO Dr. Michael Goldstein added. “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.”
