Enrollment for pSivida's pilot FAVOR clinical study commences

Sep 24 2009

pSivida Corp. (NASDAQ:PSDV)(ASX:PVA)(FWB:PV3), 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 enrollment has begun for a pilot study to assess the safety and efficacy of Iluvien® in patients with macular edema secondary to retinal vein occlusion. The trial is being sponsored by pSivida’s licensee, Alimera Sciences of Alpharetta, Georgia.

The randomized, double-masked pilot study, named FAVOR (Fluocinolone Acetonide for Vein Occlusion in Retina) compares two doses of Iluvien (0.23 and 0.45 micrograms per day).

“Retinal vein occlusion (RVO), a common disorder of the retina, is one of the leading causes of blindness after diabetic eye disease and age-related macular degeneration (AMD). Iluvien is already in phase III clinical trials for DME and is in pilot studies for wet and dry AMD,” said Dr. Paul Ashton, CEO of pSivida.

Dr. P.A. Pearson, Professor and Chairman of Ophthalmology at the University of Kentucky, an investigator in this trial added: “RVO occurs when the circulation of a retinal vein (central or branch) becomes obstructed. This occlusion can ultimately cause capillary leakage leading to macular edema, which is the leading cause of visual loss in RVP.”

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 the patient’s eye with a 25-gauge needle, which allows for a self-sealing wound. This insertion is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists. Iluvien is in pivotal Phase III clinical trials for the treatment DME. The 24-month top-line data from these Phase III trials are expected to be reported in December of this year, with an NDA expected to be filed with the FDA for approval early in 2010.