Ocular Therapeutix is seeking approval from the US Food and Drug Administration (FDA) for Dextenza (dexamethasone ophthalmic insert) to expand the current indication to include the treatment of ocular inflammation following ophthalmic surgery.
The company submitted a supplemental new drug application (sNDA) with the regulator for new indication of Dextenza.
The FDA is expected to complete the review for new indication in the second half of this year.
Dextenza is said to be the first FDA-approved intracanalicular insert that delivers dexamethasone to treat post-surgical ocular pain for up to 30 days with a single administration.
Last November, the company secured FDA approval for Dextenza ito treat ocular pain following ophthalmic surgery.
Dextenza is a resorbable and preservative-free ophthalmic insert, which is placed in the lower lacrimal punctum and into the canaliculus of the eye.
Ocular Therapeutix president and CEO Antony Mattessich said: “Submission of this sNDA on the heels of the initial Dextenza approval is another significant milestone for Ocular Therapeutix.
“The potential market opportunity for postoperative ocular pain and inflammation is substantial and there remains an important unmet need to address the issue of non-compliance given currently available treatment options.”
Ocular has submitted sNDA based on data of two earlier phase 3 clinical trials, as well as safety and efficacy data from an additional prospective, multicenter, randomized and controlled phase 3 clinical trial of Dextenza in cataract surgery patients that showed statistical significance compared to the vehicle control for the endpoints of absence of ocular pain and absence of inflammation.
According to the company, the ocular safety profile was similar to that showed in the two prior phase 3 clinical studies.
The firm has also submitted an application to Centers for Medicare & Medicaid Services (CMS) for transitional pass-through payment status and an application for a J-code, in relation with the approval and planned commercial launch of Dextenza.
Ocular Therapeutix is engaged in the formulation, development, and commercialization of advanced therapies for diseases and conditions of the eye through using its bioresorbable hydrogel-based formulation technology.