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pSivida Ltd. Reports Operating Results (10-K)

September 27, 2010 | About:
10qk

10qk

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pSivida Ltd. (PSDV) filed Annual Report for the period ended 2010-06-30.

Psivida Ltd. has a market cap of $81.81 million; its shares were traded at around $4.415 with a P/E ratio of 10.03 and P/S ratio of 3.55.

Highlight of Business Operations:

As part of the FAME Study, investigators were able to re-treat each patient with Iluvien following their month 12 follow-up visit. Through month 24, 24.5% of patients had been treated with more than one Iluvien insert and 2.5% of patients had been treated with more than two Iluvien inserts.

The FAME Study protocol provides for analysis of the all-randomized and treated data set, which includes 953 patients randomized into the FAME Study and treated, with data imputation employed, using the LOCF method, for data missing because of patients who discontinued the trial or are unavailable for follow-up (the ART Data Set). Three patients who were randomized, but not treated, are included in the Full Data Set and excluded from the ART Data Set. In the ART Data Set, the primary efficacy endpoint was met with statistical significance for both doses of Iluvien in both Trial A and Trial B. The percentage of patients in the ART Data Set achieving improved BCVA of 15 or more letters at month 24 for Trial A is 14.7% for the control group, 26.8% for the low dose (p-value 0.029) and 26.2% for the high dose (p-value 0.032). The percentage of patients in the ART Data Set achieving improved BCVA of 15 or more letters at month 24 for Trial B is 17.8% for the control group, 30.8% for the low dose (p-value 0.028) and 31.3% for the high dose (p-value 0.026).

The protocol also provides for analysis of the modified ART Data Set, which includes all 953 patients included in the ART Data Set and excludes data collected subsequent to the use of treatments prohibited by the protocol, such as Avastin®, Lucentis, triamcinolone acetonide or vitrectomy (the Modified ART Data Set). In instances when a treatment prohibited by the FAME Study protocol was used, the last observation prior to the protocol violation was imputed forward to month 24 using the LOCF method. The percentage of patients in the Modified ART Data Set achieving improved BCVA of 15 or more letters for Trial A is 12.6% for the control group, 22.6% for the low dose (p-value 0.057) and 24.1% for the high dose (p-value 0.026). Neither dose of

Iluvien for Trial A was statistically significant based on the H-B procedure. The percentage of patients in the Modified ART Data Set achieving improved BCVA of 15 or more letters at month 24 for Trial B is 13.3% for the control group, 29.7% for the low dose (p-value 0.004) and 29.3% for the high dose (p-value 0.005). Both doses of Iluvien for Trial B were statistically significant.

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