Ocular Therapeutix submits supplemental NDA for Dextenza
A supplemental new drug application for Dextenza has been submitted to the FDA to expand its indication to include the treatment of ocular inflammation after ophthalmic surgery, Ocular Therapeutix announced in a press release.
Dextenza (dexamethasone ophthalmic insert) was approved by the FDA in November 2018 and is currently indicated for postsurgical ocular pain.
“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 noncompliance given currently available treatment options,” Antony Mattessich, Ocular Therapeutix president and CEO, said in the release.
In addition, Ocular Therapeutix has submitted an application to CMS for transitional pass-through payment status and an application for a J-code for Dextenza, the release said.