Durasert for posterior segment uveitis meets primary efficacy endpoint in phase 3 trial

Durasert, a 3-year treatment for posterior segment uveitis, achieved its primary efficacy endpoint in a second phase 3 trial, pSivida announced in a press release.

The insert significantly reduced the recurrence of posterior segment uveitis in patients through 6 months of treatment, with 21.8% of patients in the Durasert treatment group experiencing a recurrence of posterior segment uveitis compared with 53.8% of patients in a sham group (P < .001).

Nancy Lurker, president and CEO of pSivida, said in the release that the company is “on track” to file a new drug application with the FDA in the fourth quarter and that a European Market Authorization Application submission is expected by the end of June.

The trial included 153 patients who received Durasert with a primary endpoint of prevention of recurrence of posterior uveitis at 6 months. The patients were followed for an additional 36 months.

Regarding other safety results, at 6 months, Durasert patients had a mean 2.4 mm Hg IOP elevation compared with 1.3 mm Hg in the sham cohort; 41.6% of patients treated with Durasert required an IOP-lowering therapy at any time during the first 6 months compared with 34.6% in the sham group. No IOP surgery was needed during this time period.

“The data from this trial confirms previous clinical research demonstrating our 3-year Durasert insert for posterior segment uveitis may significantly help patients suffering from this devastating disease — the third leading cause of blindness,” Lurker said in the release.