This article is more than 5 years old. Information may no longer be current.
FDA accepts Ocular Therapeutix NDA filing of Dextenza for postoperative ocular pain
Click Here to Manage Email Alerts
Ocular Therapeutix has received FDA acceptance of its new drug application filing for Dextenza to treat postoperative ocular pain, according to a company release.
“This is an important milestone for the company and we will continue to work diligently with the FDA as they complete their review,” Amar Sawhney, PhD, president, CEO and chairman of Ocular Therapeutix, said in the release.
The Dextenza depot is inserted into the canaliculus where it releases dexamethasone over 4 weeks before resorbing and exiting the nasolacrimal system, according to the release.
“Dextenza would provide a full postoperative course of therapy with one-time administration as compared to the current standard of care, which requires a complex and tapering regimen of multiple eye drops on a daily basis,” Sawhney added. “We are excited to potentially offer both surgeons and their patients a novel alternative to steroid eye drop therapy.”
The FDA review will be based on results from the company’s phase 2 and 3 trials of Dextenza to treat postsurgical inflammation and pain.
The FDA has set the Prescription Drug User Fee Act target action date for July 24, 2016, according to the release.