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 accounts for the majority of cases of severe vision loss. Medidur FA, a tiny, injectable intravitreal insert, is currently being studied as a way to deliver a very low dose of fluocinolone acetonide, a corticosteroid, to the retina for up to three years as a treatment for diabetic macular edema (DME) in the FAME Phase III clinical trial. Using a proprietary 25 gauge injector system, an eye care professional injects the Medidur insert into the vitreous through a minimally invasive procedure in an outpatient setting.
About Alimera Sciences Inc.
Alimera Sciences Inc. is singularly focused on the development and commercialization of prescription ophthalmology pharmaceuticals. Founded by an executive team with extensive development and revenue growth expertise, Alimera Sciences' products are focused on improving the delivery of therapeutic agents to enhance patients' lives and strengthen physicians' ability to manage ocular conditions.
Alimera completed enrollment in October 2007 of its 956-patient Phase III clinical trial of fluocinolone acetonide in the Medidur(TM) drug delivery system for the treatment of diabetic macular edema. Alimera has 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 for ophthalmic diseases. The agreement gives Alimera the exclusive option to license compounds which are NADPH (nicotinamide adenine dinucleotide phosphate reduced form) oxidase inhibitors 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 retains the right to use the Medidur delivery system for two of these compounds.
|SOURCE Alimera Sciences Inc.|
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