Alimera Sciences Begins Pilot Study of Iluvien(R) in Patients With Macular Edema Secondary to Retinal Vein Occlusion

ATLANTA, Sept. 23 /PRNewswire/ -- Alimera Sciences, Inc., a privately held biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today reported that enrollment has begun for a pilot study to assess the safety and efficacy of Iluvien(R) in patients with macular edema secondary to retinal vein occlusion.

The randomized, double-masked pilot study, named FAVOR (Fluocinolone Acetonide for Vein Occlusion in Retina), compares two doses of Iluvien (0.23 and 0.45 micrograms per day).

About Retinal Vein Occlusion

Retinal vein occlusion (RVO), a common vascular disorder of the retina, is one of the most common causes of blindness after diabetic retinopathy. RVO occurs when the circulation of a retinal vein (central or branch) becomes obstructed. This occlusion can ultimately cause capillary leakage leading to macular edema, which is the leading cause of visual loss in RVO.

About Iluvien(R)

Iluvien is an investigative, extended release intravitreal insert that Alimera is developing for the treatment of diabetic macular edema (DME). Each Iluvien insert is designed to provide a sustained therapeutic effect of up to 36 months, for the low dose of Iluvien, and up to 24 months, for the high dose of Iluvien. Iluvien is inserted into the patient's eye with a 25-gauge needle, which allows for a self-sealing wound. This insertion is very similar to an intravitreal injection, a procedure commonly employed by retinal specialists.

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, 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.

For more information on Alimera Sciences, visit www.alimerasciences.com.

SOURCE Alimera Sciences, Inc.



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