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