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Sustained-release Dextenza meets endpoints for post-cataract surgery pain
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NEW ORLEANS — Sustained-release dexamethasone was superior to placebo in managing pain and preventing inflammation after cataract surgery, a speaker told colleagues here.
At the American Society of Cataract and Refractive Surgery meeting, Joseph Gira, MD, reported results of two phase 3 prospective, multicenter, randomized studies of Dextenza (sustained-release dexamethasone intracanalicular depot, Ocular Therapeutix).
“Dextenza was superior over placebo for the absence of pain at day 8. There was a strong safety profile. It was superior over placebo in the absence of cells in the first study but did not meet the endpoint in the second study. It still showed that the performance of anti-inflammatory properties was very good,” Gira said.
The FDA accepted a new drug application for Dextenza in December 2015 and set a target action date of July 24 under the Prescription Drug User Fee Act.
The first phase 3 study included 247 patients, and the second study included 241 patients.
Patients were randomized 2:1 to receive dexamethasone or placebo.
Primary endpoints for both studies were absence of anterior chamber cells at 14 days and absence of pain at 8 days after cataract surgery.
In the first study, dexamethasone met both primary endpoints and showed a high safety profile. In the second study, it met the pain endpoint but not the inflammation endpoint. However, it showed a high safety profile.
In the first study, 33% of patients in the dexamethasone group and 14% of those in the placebo group had no anterior chamber cells at 14 days. In the second study, 39% of patients in the dexamethasone group and 31% of those in the placebo group had no cells.
“The difference was that in the placebo group, they had an increased response. ... Inflammation was definitely improved in both studies,” Gira said.
No product- or treatment-related serious adverse events were reported in either study, he said.
A third phase 3 study is underway to expand labeling to include inflammation, Gira said. – by Matt Hasson and Patricia Nale, ELS
Reference:
Gira J. Safety and efficacy of sustained-release dexamethasone to treat ocular inflammation and pain after cataract surgery: multicenter evaluation. Presented at: American Society of Cataract and Refractive Surgery meeting; May 6-10, 2016; New Orleans.
Disclosure: Gira reports no relevant financial disclosures.