pSivida completes enrollment for phase 3 trial of Medidur for posterior uveitis

pSivida completed the target enrollment of 120 patients in a phase 3 clinical trial of Medidur to treat posterior uveitis, according to a press release.

The double-masked study will compare Medidur vs. sham injections on a two-to-one basis to determine recurrence of posterior uveitis within 1 year. Patients are enrolled at centers in the United States, the European Union and India.

pSivida will seek regulatory approval based on the safety and efficacy data from the phase 3 trial and short-term data from a utilization study of pSivida’s proprietary inserter, the release said.

The company expects to report top-line results in the second half of 2016 and to file for regulatory approval in late 2016 or early 2017, the release said.

Medidur, an injectable micro-insert, delivers fluocinolone acetonide over 36 months. It uses the same design, polymers, drug and dose as Iluvien (fluocinolone acetonide intravitreal implant 0.19 mg, Alimera Sciences), which was developed by pSivida and is approved for the treatment of diabetic macular edema.

“The FDA has confirmed that pSivida can reference much of the data, including the clinical safety data, from the phase 3 clinical trials of Iluvien for DME,” the release said.