Phase III results for Durasert confirm reduction in uveitis recurrence rate.- pSivida.

pSivida announced that results from the Company's second Phase III trial for Durasert three-year treatment for posterior segment uveitis confirmed a significant reduction in uveitis recurrence rate at 12 months. The study involved 153 patients with posterior segment uveitis and the primary endpoint was prevention of recurrence of posterior uveitis at six months with patients continuing to be followed for 36 months. The key highlights from the trial at 12 months included a significant reduction in the recurrence of posterior segment uveitis through 12 months; 36.6% of Durasert-treated patients had a recurrence compared to 71.2% of patients in the sham group.

In addition thee was a mean increase of intraocular pressure (IOP) of 2.0 and 0.0 mm Hg at 12 months over a baseline IOP of 13.3 and 13.1 mm Hg for Durasert and sham, respectively. Patients requiring IOP-lowering therapy at any time during the first 12 months of follow-up were 50.5% for Durasert and 51.9% for sham. Only one patient, assigned to Durasert, required IOP surgery during the first 12 months of follow-up. In patients with a natural (phakic) lens at baseline, 18.0% in the Durasert group required cataract surgery through 12 months compared to 8.6% in the sham group.

Comment: In January 2018, Sivida Corp. submitted its New Drug Application to the FDA for Durasert three-year treatment for posterior segment uveitis. The NDA included data from two Phase III studies that each successfully achieved the primary efficacy endpoint at six months. In addition, the safety profile of patients treated with Durasert three-year posterior segment uveitis treatment was consistent with the safety profile of steroid treatments that are currently considered standard of care for this disease.