pSivida presents data of ILUVIEN Phase 3 trial in Diabetic Macular Edema at ARVO 2011

pSivida Corp. (NASDAQ: PSDV)(ASX: PVA), a leader in developing sustained release, drug delivery products for treatment of back-of-the-eye diseases, today announced the presentation of new data from the completed 36-month FAME™ Study of ILUVIEN for the treatment of Diabetic Macular Edema (DME) at the 2011 ARVO Annual Meeting. The new data, presented by Dr. Andrew N. Antoszyk, analyzed the subgroup of patients who had been diagnosed with DME for three or more years at entry of the FAME Study (which comprises over 50% of patients in the Study). ILUVIEN is licensed by pSivida to Alimera Sciences, Inc. Alimera reported that it plans to submit this new subgroup data to the FDA in support of its pending New Drug Application.

In the data reported for this subgroup at 36 months in Trial A, 31.8% of patients treated with ILUVIEN experienced an improvement in best corrected visual acuity (BCVA) of 15 or more letters from baseline compared with 13.6% of those in the control group.

In the subgroup, peak efficacy was seen at month 30, with 33.6% of ILUVIEN treated patients in Trial A gaining 15 or more letters in BCVA compared to 10.2 % of control (p < 0.001) and 42.4% of ILUVIEN treated patients in Trial B gaining 15 or more letters in BCVA Trial B compared to 11.3% of control (p< 0.001).

Consistent with the full patient population in the FAME Study, approximately 75% of the patients in this subgroup treated with ILUVIEN were reported to have received only one ILUVIEN insert over the 36 month study.

There was no statistically significant difference in BCVA improvement in the subgroup of patients with less than three years' duration of DME at entry compared to control.

Safety data for patients within the subgroup of patients with DME diagnosis of at least 3 years' duration were also reported. Generally, subgroup patients receiving ILUVIEN experienced fewer pressure-related side effects compared to control than was reported for the full patient population in the trial. By the end of the 36-month study, intraocular pressure (IOP) increases to 30 millimeters of mercury (mmHg) or greater at any time point were seen in 14.8% of the subgroup patients (5.4% of control), as contrasted with 18.4% of the full patient population (4.3% of control). By month 36, 5.3% of the subgroup patients had undergone an incisional surgical procedure to reduce elevated IOP (0.0% of control), compared to 4.8% in the full patient population (0.5% of control). During the study, 35.9% of the subgroup (15.2% of control) had received IOP-lowering medication compared to 38.4% of the full patient population (14.1% of control).

Data on cataracts for the subgroup were also reported. At the entry of the trial, many patients had already received cataract surgery. Of the remaining patients with a natural lens, the incidence of cataracts was 86.0% at month 36 for the subgroup (51.5% for control), with 85.1% undergoing a cataract operation (36.4% for control). By comparison, in the phakic full study patient population, the incidence of cataracts was 81.7% at month 36 (50.4% for control), with 74.9% undergoing a cataract operation (27.3% for control).

The FAME Study consisted of two three-year, Phase 3 pivotal clinical trials (Trial A and Trial B) to assess the safety and efficacy of ILUVIEN® in the treatment of DME. The 956 patients in the trials were randomized to receive either high dose ILUVIEN, low dose ILUVIEN or control treatment. The primary endpoint for efficacy in the trials was the difference in the percentage of patients whose BCVA improved by 15 or more letters from baseline on the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart at month 24 between the treatment and control groups.

As previously reported, the pre-specified 24-month primary endpoint for the FAME Study was met for the low dose ILUVIEN in both Trial A and Trial B. Based on these data, Alimera submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) on June 29, 2010 for approval of the low dose ILUVIEN. Therefore, only the low dose data is presented and discussed in this press release. As previously reported, Alimera received a Complete Response Letter from the FDA in December 2010, requesting analyses of safety and efficacy data through month 36 of the FAME Study, including exploratory analyses in addition to those previously submitted in the NDA, to further assess the relative benefits and risks of ILUVIEN.

In February 2011, Alimera reported results from the full patient population at month 36 of the FAME Study.

Paul Ashton, President and Chief Executive Officer, said, "We are very pleased with the efficacy and safety results through month 36 in patients with chronic DME. This subgroup comprised a majority of patients in the FAME Study. We look forward to Alimera's filing of this data with the FDA in connection with the NDA for ILUVIEN."

Data for the subgroup analyses was gathered from 536 patients who had been diagnosed with DME for three years or more and 416 patients who had been diagnosed with DME for less than three years.