pSivida enrols first patient for uveitis trial

pSivida (ASX:PVA) has enrolled the first patient for a US clinical trial of its Medidur injectable micro-inserts to treat the eye disease posterior uveitis.

The investigator-sponsored trial will help guide the design for a planned phase III trial of the Medidur sustained-release inserts and ILUVIEN drug, which will support an FDA application.

The final design and clinical endpoints of the phase III trial are still being worked out with the agency.

pSivida is developing the inserts as a treatment for posterior uveitis, an inflammatory disease over a layer of the eye.

The disease is estimated to be the third leading cause of blindness in the US, affecting around 175,000 people of whom some 30,000 are blind.

The eyelash-sized Medidur implants are designed to release ILUVIEN, or fluocinolone acetonide, into the back of the eye over sustained periods of up to 36 months.

The product is based on the same design as the product pSivida has licensed to Alimera Sciences as a treatment for Diabetic Macular Edema.

Alimera has received approval for Medidur in several European countries, but has been struggling to gain approvals from the FDA.

In the most recent hold-up, the FDA in November asked Alimera to conduct two more clinical trials, after finding that the company's NDA provided insufficient data about the safety and efficacy of the treatment.

The FDA has so far approved two of pSivida's sustained release products to treat back-of-eye diseases, Retisert and Vitrasert, both of which are licensed to Bausch & Lomb.

pSivida (ASX:PVA) shares were up 5c to $2.25 in morning trading today.