Successful Phase III trial for Medidur to treat chronic noninfectious uveitis.- pSivida Corp.

pSivida Corp., announced positive topline results from its first Phase III clinical trial evaluating the safety and efficacy of Medidur for the treatment of chronic noninfectious uveitis affecting the posterior of the eye (posterior uveitis). The 129 patient, multi-center, randomized and double-blinded trial was highly statistically significant in meeting its primary efficacy endpoint of prevention of recurrence of disease at six months (p less than 0.00000001; intent to treat analysis). Safety results were positive. Only 10.9% more Medidur-treated eyes than control eyes experienced an increase in intraocular pressure (IOP) above 21 mmHg through six months, which was reduced to 6.1% through the most recent follow-up visits (some as long as 24 months). In the Medidur trial, 87 eyes were treated with Medidur, and 42 eyes were randomized to control and received a sham injection.

At six-months of follow-up: 1.18.4% of Medidur-treated eyes compared to 78.6% of control eyes had experienced recurrence of posterior uveitis (a statistically significant p less than 0.00000001).2. 23.0% of Medidur-treated eyes compared to 4.9% of control eyes showed improvement in visual acuity gaining 15 or more letters from baseline on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart (a statistically significant p = 0.011). 3. 31.0% of control eyes compared to 4.6% of Medidur-treated eyes had lost 15 or more letters from baseline on the ETDRS Eye Chart for at least one observation (a statistically significant p less than 0.0001). 4. 52.4% of control patients compared to 18.2% of Medidur-treated patients were still being administered systemic treatment (a statistically significant p less than 0.01). 5. 27.6% of Medidur-treated eyes compared to 16.7% of control eyes had experienced an increase in intraocular pressure (IOP) above 21 mmHg for at least one observation. 6.Of the 64 study eyes with a natural lens at baseline, 9.5% of Medidur-treated eyes compared to 4.8% of control eyes had required cataract surgery.

Comment: Medidur is an injectable micro-insert designed to treat posterior uveitis. Injected into the back of the eye, it provides sustained release of 0.18 mg of the corticosteroid flucinolone acetonide at a controlled rate directly to the retina for three years. Medidur comprises the same micro-insert as Iluvien for DME. Iluvien has been approved in the U.S. and 17 EU countries and is sold by pSivida's licensee in the U.S., (Alimera Biosciences) and in the U.K., Germany and Portugal.