This article is more than 5 years old. Information may no longer be current.

Ocular Therapeutix reports successful topline results in phase 3 trial of Dextenza

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

A phase 3 clinical trial of Dextenza 0.4 mg for the treatment of post-surgical ocular inflammation and pain has shown positive topline results, according to a press release from Ocular Therapeutix.

The double-masked, parallel-arm, randomized study included 438 patients who underwent clear corneal cataract surgery at 21 sites across the United States. The patients received either Dextenza (dexamethasone insert) or a placebo vehicle. Those treated with Dextenza showed “statistically significant differences” in regards to pain and inflammation, according to the release.

On day 14, 52.3% of those treated with Dextenza had an absence of inflammatory cells in the anterior chamber compared with 31.1% of those who received placebo (P < .0001). In regards to pain, 79.6% of patients treated with Dextenza reported an absence of pain on day 8 compared with 61.3% of patients who received placebo (P < .0001).

Ocular Therapeutix is planning to resubmit its FDA new drug application for Dextenza for the ocular pain indication before the end of the year; if it is approved, the company will then submit a supplement to seek an indication for post-surgical ocular inflammation, the release said.