Psivida Corp. Reports Iluvien™ Phase III Studies for DME
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pSivida Corp. has reported that an independent Data Safety Monitoring Board (DSMB) has recommended the continuation of two pivotal Phase III clinical trials for the use of Iluvien™ (formerly known as Medidur FA™) in the treatment of diabetic macular edema (DME) under the current protocol, without change.
The clinical trials are being conducted by the company’s licensing partner, Atlanta-based Alimera Sciences, Inc. Top line data from the trials is expected to be available at the end of this year.
The DSMB completed its final review of the currently available safety and efficacy data prior to the 24 month readout scheduled in October 2009. A DSMB provides an independent evaluation of all trial data to identify potential safety issues that might warrant modification or early termination of ongoing clinical studies.
These clinical trials, known collectively as the FAME™ Study (Fluocinolone Acetonide in Diabetic Macular Edema), consist of two 36-month, doublemasked, randomized, multicenter trials in the U.S., Canada, Europe and India in support of a planned global registration filing. The NDA will be filed with safety and efficacy assessed after 24 months of follow-up.
“pSivida is pleased that the DSMB recommended the continuation of the FAME Study without change,” said pSivida CEO, Dr. Paul Ashton. “We are looking forward to the last patient’s last visit for the 24-month readout scheduled in October later this year. The NDA filing for Iluvien remains on schedule for early 2010.”
He added, “This is another positive development for Iluvien. Last month the company reported very encouraging 12-month interim safety and efficacy data from the first human pharmacokinetic (PK) study of Iluvien which continued to be consistent with our expectations regarding Iluvien.”
The clinical trials are being conducted by the company’s licensing partner, Atlanta-based Alimera Sciences, Inc. Top line data from the trials is expected to be available at the end of this year.
The DSMB completed its final review of the currently available safety and efficacy data prior to the 24 month readout scheduled in October 2009. A DSMB provides an independent evaluation of all trial data to identify potential safety issues that might warrant modification or early termination of ongoing clinical studies.
These clinical trials, known collectively as the FAME™ Study (Fluocinolone Acetonide in Diabetic Macular Edema), consist of two 36-month, doublemasked, randomized, multicenter trials in the U.S., Canada, Europe and India in support of a planned global registration filing. The NDA will be filed with safety and efficacy assessed after 24 months of follow-up.
“pSivida is pleased that the DSMB recommended the continuation of the FAME Study without change,” said pSivida CEO, Dr. Paul Ashton. “We are looking forward to the last patient’s last visit for the 24-month readout scheduled in October later this year. The NDA filing for Iluvien remains on schedule for early 2010.”
He added, “This is another positive development for Iluvien. Last month the company reported very encouraging 12-month interim safety and efficacy data from the first human pharmacokinetic (PK) study of Iluvien which continued to be consistent with our expectations regarding Iluvien.”
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