Alimera Reports Results From the Six-Month Interim Readout of the Human PK Iluvien...(20 percent at the three-month readout to...),Health

Date:10/1/2008

20 percent at the three-month readout to 10 percent because one patient developed a cataract and one patient developed an epiretinal membrane involving the macula prior to the readout. The development of cataracts and epiretinal membranes in a diabetic population are not unusual and are commonly addressed with surgical intervention.

In addition, the six-month readout showed 25 percent of the low dose patients and 41 percent of the high dose patients had an improvement in BCVA of 10 letters or greater from baseline. This is an improvement from the three-month data where 20 percent of low dose patients and 29 percent of high dose patients had gained more than 10 letters compared to baseline.

"It is very encouraging that the number of patients with greater than 10-letter improvement has increased for both doses when comparing the six- month data to the three-month data," said Ken Green, Ph.D., chief scientific officer of Alimera.

From a safety perspective, no adverse events related to intraocular, or inner eye, pressure were seen in the low dose patients, while 12 percent of the high dose patients experienced intraocular pressure increases of 30 mmHg or greater at some time point. Further, 10 percent of the low dose patients and 12 percent of the high dose patients reported an adverse event related to cataract formation, and one additional patient in each dose group underwent a cataract extraction.

"The six-month readout from the Iluvien PK study continues to support the premise that corticosteroids, delivered in low doses in a consistent and sustained manner directly into posterior segment of the eye, can be an efficacious treatment for DME," said Dan Myers, president and CEO of Alimera Sciences, "We are also pleased with Iluvien's safety profile as evidenced by the low IOP rates and the lack of filtration procedures at the month 6 time point."

Data from the PK Study will continue to be evaluated with interim looks at months 12, 18,
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SOURCE Alimera Sciences, Inc. Copyright©2008 PR Newswire. All rights reserved

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