pSivida initiates phase 3 trials of injectable insert for posterior uveitis

pSivida has announced the commencement of the first of two planned phase 3 trials of its injectable micro-insert in patients with posterior uveitis, according to a company press release.

The trials are expected to enroll a total of approximately 300 patients, with the primary endpoint being the recurrence of uveitis within 12 months, according to the release.

The same micro-insert is currently marketed in the European Union as Iluvien (sustained-release fluocinolone acetonide) for the treatment of chronic diabetic macular edema (DME) by pSivida’s collaborative partner, Alimera Sciences. The uveitis application is being independently developed by pSivida, the release said.

pSivida has also announced interim data from an investigator-sponsored phase 1/2 study of its injectable micro-insert in patients with posterior uveitis. The studies revealed that through the first 12 months of enrollment, none of the treated eyes had a recurrence of uveitis, and inflammation was reduced in all treated eyes. By contrast, fellow untreated eyes showed either recurrence of uveitis or worsening, or no improvement in inflammation, according to the release.

The interim data also showed that the micro-inserts were well-tolerated, and the observed safety profile was consistent with the short-term safety profile reported in clinical studies of Iluvien in DME subjects, with one exception: IOP measurements of treated eyes all remained in the normal range. One treated eye, which at baseline had a history of elevated IOP, required surgery to control pressure, the release said.