Ocular Therapeutix announced the submission of a supplemental new drug application (NDA) to the FDA for Dextenza (dexamethasone ophthalmic insert). The sNDA filing seeks to expand the current indication for Dextenza to include the treatment of ocular inflammation following ophthalmic surgery. The company expects that the FDA review will be completed in the second half of 2019.
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. Dextenza received FDA approval in November 2018 for the treatment of ocular pain following ophthalmic surgery. Dextenza is a resorbable, preservative-free ophthalmic insert that is placed in the lower lacrimal punctum and into the canaliculus of the eye.
“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,” Antony Mattessich, the company’s President and Chief Executive Officer, said in a company news release. “This is another major step toward our goal of making eye-drop therapies obsolete.”
The sNDA is supported by the two previous phase 3 clinical trials and safety and efficacy data from an additional prospective, multicenter, randomized, controlled phase 3 clinical trial of Dextenza (n=438) in cataract surgery patients that demonstrated statistical significance compared to the vehicle control for the endpoints of absence of ocular pain (P<0.0001) and absence of inflammation (p<0.0001). The ocular safety profile was similar to that demonstrated in the two prior phase 3 clinical trials. Data from the third phase 3 clinical trial were recently published in the Journal of Cataract & Refractive Surgery (JCRS) in October 2018.
In connection with the approval and anticipated commercial launch of Dextenza, Ocular Therapeutix 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.