Ocular Therapeutix (NSDQ:OCUL) touted interim data today from its phase III trial of Dextenza for the treatment of post-surgical ocular inflammation and pain. The bioresorbable intracanalicular hydrogel plug is designed to release drugs at the ocular surface for up to 30 days.
The company announced last month that Dextenza met the trial’s 2 primary efficacy endpoints: absence of ocular pain after 8 days and lack of inflammation after 2 weeks compared to a placebo. Bedford, Mass.-based Ocular said today that the dexamethasone insert also met its secondary endpoint of absence of ocular flare in the anterior chamber when compared to a placebo. Nearly half of patients in the Dextenza treatment arm had an absence of anterior chamber flare after 4 days following insertion.
The company also reported differences in the absence of anterior chamber cells and ocular pain on days 2, 4, 14 and 30. No serious adverse events related to treatment have been reported throughout the phase III trial, according to the company.
“The positive results for the secondary endpoint of absence of ocular flare build upon the successful topline results from this trial which we announced last month,” chief medical officer Dr. Jonathan Talamo said in prepared remarks. “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.”
In July last year, the FDA denied approval for Dextenza, citing “deficiencies in manufacturing process and controls” which were identified during a pre-new drug application approval inspection of its manufacturing facility..
Shares in the company surged in November last year, when the company reported it will soon re-submit its new drug application to the FDA.