Fluocinolone acetonide implantable device for diabetic retinopathy.

Diabetic retinopathy remains a major worldwide cause of preventable visual loss. Although photocoagulation and improved metabolic control are effective for patients with diabetic macular edema and proliferative diabetic retinopathy, some patients continue to lose vision despite treatment. Various classes of pharmacotherapy have shown promise in the treatment of diabetic retinopathy, including corticosteroids, anti-vascular endothelial growth factor agents, and others. Off-label intravitreal corticosteroids are associated with short-term anatomic and visual improvement in some patients, but these patients may require repeated intravitreal injections with cumulative risks of cataract formation, intraocular pressure elevation, and endophthalmitis. Various sustained-release corticosteroid delivery systems have been investigated for this purpose. The first to become widely available is the fluocinolone acetonide intravitreal implant (Retisert, Bausch & Lomb, Rochester, NY), which received U.S. Food and Drug Administration approval to treat chronic, noninfectious posterior segment uveitis in 2005. This device also has been investigated as a treatment for diabetic macular edema. Multiple randomized clinical trials have demonstrated medium-term anatomic and visual improvement, but the device is associated with high risks of cataract formation and intraocular pressure elevation. At this time, the device is not widely used in the treatment of diabetic retinopathy. A smaller device, designed to be injected in a clinic setting (Iluvien, Alimera Sciences, Alpharetta, GA) is currently being investigated for the treatment of diabetic macular edema. Results from a phase 3 randomized controlled trial have recently reported medium-term efficacy and safety in the treatment of diabetic macular edema. Combination photocoagulation and pharmacotherapy with these devices has not yet been reported.