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Phase 3 study shows Dextenza resolves pain, inflammation quicker than placebo
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LOS ANGELES — The results of a third phase 3 study comparing the safety and efficacy of a sustained-release dexamethasone insert vs. a placebo for postoperative cataract surgery patients showed a statistically significant superiority for postoperative absence of pain and inflammation, according to a speaker here.
“Dextenza (sustained-release dexamethasone intracanalicular depot, Ocular Therapeutix) showed a statistically significant improvement as early as day 2 for pain and day 4 for inflammation,” Eric D. Donnenfeld, MD, said at the American Society of Cataract and Refractive Surgery meeting.
Eric D. Donnenfeld
In the study, 216 patients received the 0.4 mg dexamethasone insert and 222 patients received a placebo after cataract surgery. For pain, 79.6% of Dextenza patients had an absence of ocular pain by 8 days postoperatively compared with 61.3% of placebo patients (P < .0001). Additionally, 52.3% of Dextenza patients had an absence of anterior chamber inflammation by day 14 compared with 31.2% of placebo patients (P < .0001), Donnenfeld said.
“The most common adverse event was eye inflammation and increased intraocular pressure, but there were no treatment-related serious adverse events in the entire trial,” he said. – by Robert Linnehan
Reference:
Donnenfeld ED. Safety and efficacy of a dexamethasone insert for treatment of ocular inflammation and pain after surgery: a phase 3 study. Presented at: American Society of Cataract and Refractive Surgery annual meeting; May 5-9, 2017; Los Angeles.
Disclosure: Donnenfeld reports he is a consultant for Ocular Therapeutix.