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 greater than 30 mmHg. Additionally, the only adverse event related to cataract formation was reported in a patient in the high dose group.
The early readout from this PK Study provides further insight into the dose-response of FA in the treatment of DME. By comparison, Bausch & Lomb's Retisert(R) (fluocinolone acetonide intravitreal implant), with an initial release dose of 0.6 microgram per day, was also studied in a DME population. It demonstrated a significant improvement in visual acuity at one year, comparable to the Iluvien results reported here; however, a lower dose was not tested. Therefore, it has not been determined if Retisert's dosage level represents the lowest efficacious dose for DME.
"We believe this early readout from our PK Study supports our premise that lower doses of FA delivered by Iluvien will provide visual acuity improvements while reducing the risk of ocular side effects commonly associated with the use of corticosteroids," said Ken Green, Ph.D., chief scientific officer for Alimera.
Data from this open-label study will be evaluated on an ongoing basis with interim looks at months 3, 6, 12, 18, 24, 30 and 36. Except for the month 12 and final month 36 looks, when the database will be fully locked, interim evaluations will be based on unaudited data. The last patient was enrolled in this study at the end of February 2007.
About Alimera Sciences, Inc.
Alimera Sciences is a biopharmaceutical company that specializes in the
research, development and commercialization of prescription ophthalmic
|SOURCE Alimera Sciences, Inc.|
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