Dextenza meets secondary endpoint in phase 3 trial

A phase 3 clinical trial of Dextenza for the treatment of post-surgical inflammation and pain has shown successful secondary endpoint results, according to a press release from Ocular Therapeutix.

The bioresorbable intracanalicular insert is designed to release dexamethasone to the ocular surface for up to 30 days. For all measured time points, the secondary endpoint of absence of anterior chamber flare was statistically superior to placebo. On the fourth day after implantation, 46% of patients who received Dextenza had no anterior chamber flare, the release said.

“Ocular flare occurs when the protein content of the aqueous humor increases due to intraocular inflammation, so the fact that we are seeing a statistically significant decrease in the absence of flare across all time points further supports the efficacy profile of Dextenza,” Jonathan H. Talamo, MD, chief medical officer of Ocular Therapeutix, said in the release.

Dextenza previously met the trial’s two primary efficacy endpoints: the absence of ocular pain on day 8 and the absence of ocular inflammation on day 14 compared with placebo.

A safety assessment of the trial will be released later this quarter.

A phase 3 clinical trial of Dextenza for the treatment of post-surgical inflammation and pain has shown successful secondary endpoint results, according to a press release from Ocular Therapeutix.

The bioresorbable intracanalicular insert is designed to release dexamethasone to the ocular surface for up to 30 days. For all measured time points, the secondary endpoint of absence of anterior chamber flare was statistically superior to placebo. On the fourth day after implantation, 46% of patients who received Dextenza had no anterior chamber flare, the release said.

“Ocular flare occurs when the protein content of the aqueous humor increases due to intraocular inflammation, so the fact that we are seeing a statistically significant decrease in the absence of flare across all time points further supports the efficacy profile of Dextenza,” Jonathan H. Talamo, MD, chief medical officer of Ocular Therapeutix, said in the release.

Dextenza previously met the trial’s two primary efficacy endpoints: the absence of ocular pain on day 8 and the absence of ocular inflammation on day 14 compared with placebo.

A safety assessment of the trial will be released later this quarter.