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Pilot Study to Assess Safety and Efficacy of Medidur(TM) FA in AMD Patients Treated With Lucentis(R)
Date:5/8/2008

ATLANTA, May 8 /PRNewswire/ -- Alimera Sciences Inc., a privately held ophthalmic pharmaceutical company announced today that enrollment has begun for a pilot study to assess the safety and efficacy of Medidur FA in conjunction with Lucentis(R) (ranibizumab injection, Genentech) in patients with exudative age-related macular degeneration (wet AMD).

This pilot study, which will be performed under an investigator sponsored IND, will compare two doses of Medidur FA (0.2 and 0.5 ug/day) in patients who have been treated with Lucentis for at least six months. The change from baseline in parameters such as visual acuity and retinal thickness will be assessed, in addition to comparing the number of Lucentis injections post- randomization versus pre-randomization. It has been previously shown that Lucentis requires persistent dosing to maintain efficacy.

"Alimera Sciences is pleased to support this study design because it will provide preliminary information on the potential of Medidur FA to maintain the efficacy established with Lucentis while reducing the number of Lucentis treatments," said Dr. Ken Green, Senior VP and Chief Scientific Officer for Alimera Sciences.

Lucentis is an antibody that binds to VEGF, thus preventing it from interacting with its receptor and causing additional damage in patients with wet AMD. Corticosteroids inhibit VEGF secretion in addition to their anti- inflammatory action and ability to suppress leukostasis. Given these complementary actions, the concomitant use of Lucentis and Medidur is warranted in patients being treated with Lucentis for wet AMD.

AMD is a degenerative disease of the central portion of the retina (the macula) which typically occurs in patients over the age of 50. One form of the disease, exudative (or wet) AMD is characterized by the formation of leaky new blood vessels originating in the choroid which may hemorrhage and cause accumulation of sub- and intra-retinal fluid. This form of AMD
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SOURCE Alimera Sciences Inc.
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