pSivida initiates posterior uveitis trial

pSivida (ASX:PVA) has commenced a US phase III trial of its ocular insert for the treatment of posterior uveitis.

The first three US clinical sites have started recruiting patients for the study, which is one of two US trials planned to accompany a New Drug Application with the US FDA.

pSivida said the trials are expected to involve around 15 sites in the US and additional clinical sites worldwide.

The ocular micro-insert is the same as the design pSivida has licensed to Alimera Sciences for diabetic macular edema (DME) treatment Iluvien. Alimera has secured marketing approval for the product in six European countries, but is still awaiting approval in the US.

pSivida has received permission from the FDA to cite data from Alimera’s trials in its own FDA application for its posterior uveitis treatment.

The insert also delivers the same drug used in Retisert, pSivida’s existing FDA-approved posterior uveitis treatment.

“In our uveitis trials, we expect to maintain similar efficacy to that seen in the Retisert phase III trials but with a similar [low] side effect profile to that seen in DME patients in the phase III studies for Iluvien,” pSivida CEO Dr Paul Ashton said.

Another advantage the micro-insert has over Retisert is that it can be injected during an office visit, rather than implanted through a surgical procedure, he added.

pSivida shares were trading 2.69% higher at $4.20 as of around 1 pm on Wednesday.