Alimera Sciences Announces Presentation Of Data From The 12-Month Interim Readout Of The Human PK Iluvien(TM) Study At ARVO 2009 Annual Meeting

Main Category: Eye Health / Blindness
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 05 May 2009 - 0:00 PDT

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Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced that positive interim 12-month safety and efficacy results from the first human pharmacokinetic study (PK Study) of Iluvien(TM) (fluocinolone acetonide (FA) intravitreal insert) will be presented today at 2:00 p.m. at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Ft. Lauderdale, FL.

The data in the presentation, entitled "Pharmacokinetics and Pharmacodynamics of Iluvien(TM) (FA intravitreal insert) for DME," were derived from the FAMOUS Study Group, which in addition to measuring systemic levels of FA, also assessed anterior chamber levels of FA, and assessed correlations between these levels and clinical outcomes.

A total of 37 subjects with DME were randomized, 20 patients on the low dose of Iluvien and 17 patients on the high dose of Iluvien. Results showed an improvement in best corrected visual acuity associated with a reduction in center subfield thickness in a substantial number of patients for both doses, as well as no evidence of elevated intraocular pressure in the low dose.

"Alimera is excited to share more details of this study," said Dan Myers, CEO, Alimera Sciences. "We believe these results continue to be in line with our expectations regarding the safety and efficacy of Iluvien."

About Alimera Sciences, Inc.

Alimera Sciences is a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals. Presently the company is focused on diseases affecting the back of the eye, or retina. Its most advanced product candidate is Iluvien(TM), which is being developed for the treatment of diabetic macular edema, or DME. DME is a disease of the retina, which affects individuals with diabetes and can lead to severe vision loss and blindness. Under one protocol, enrollment was completed in October 2007 in two Phase 3 pivotal trials for the use of Iluvien in the treatment of DME conducted across the U.S., Canada, Europe and India.

Alimera also has entered into an exclusive worldwide agreement with Emory University to explore oxidative stress management -- specifically the reduction of reactive oxygen species (ROS) -- as a treatment strategy for ophthalmic diseases. Under this agreement, Alimera has acquired options to exclusive, worldwide licenses for two classes of nicotinamide adenine dinucleotide phosphate reduced form (NADPH) oxidase inhibitors, which Alimera is studying as potential treatments for conditions such as the dry form of age-related macular degeneration (AMD), particularly the late stage of this condition known as geographic atrophy. Alimera has exercised its option to acquire a license with respect to one of these classes of NADPH oxidase inhibitors.

Source: Alimera Sciences, Inc

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