pSivida achieves milestone in Phase III Iluvien trial, last patient completes two-year follow up visit

Oct 15 2009

pSivida Corp. (NASDAQ:PSDV)(ASX:PVA), a leading drug delivery company that has developed two of the only three products approved by the FDA for the long-term, sustained release delivery of drug to treat chronic back of the eye disease, today announced that the last patient in the Phase III clinical trial being conducted by its collaborative partner, Alimera Sciences, for a new treatment for diabetic macular edema (DME) has completed the two-year follow up visit. The Phase III studies compare two doses of Iluvien with sham treatment.

“We are very pleased that this important milestone has been achieved and we expect to see top-line 24-month data from the trial in mid-December. Assuming positive data, Alimera expects to file the NDA (New Drug Application) with the FDA in the second quarter of 2010,” said Dr. Paul Ashton, CEO of pSivida.

Iluvien is an investigative, extended release intravitreal insert currently under development for the treatment of Diabetic Macular Edema (DME). Each Iluvien insert is designed to provide a sustained therapeutic effect of up to 36 months, for the low dose Iluvien, and up to 24 months, for the high dose of Iluvien. Iluvien is inserted into a patient’s eye with a needle two thousandths of an inch in diameter, which allows for a self-sealing wound. This insertion is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists. An NDA for Iluvien is expected to be filed with the FDA in the second quarter of 2010 by Alimera.