Alimera Sciences, Inc. announced that clinical data for ILUVIEN® (fluocinolone acetonide intravitreal implant) 0.19 mg taken from the three-year, phase IV, real-world observational PALADIN study evaluating the long-term safety of ILUVIEN for patients with diabetic macular edema, will be featured in three posters and a presentation on behalf of the PALADIN Investigators, during the American Academy of Ophthalmology?s 127th Annual Meeting being held in San Francisco from November 3-6, 2023. ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg sustained release intravitreal implant is injected into the back of the eye. With its CONTINUOUS MICRODOSING technology, ILUVIEN is designed to release sub-microgram levels of fluocinolone acetonide, a corticosteroid, for 36 months, to reduce the recurrence of disease, enabling patients to maintain vision longer with fewer injections.

ILUVIEN is approved in the U.S., Canada, Kuwait, Lebanon and the U.A.E. to treat diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. In 17 European countries, ILUVIEN is indicated for the treatment of vision impairment associated with chronic DME considered insufficiently responsive to available therapies, and for prevention of relapse in recurrent non-infectious uveitis affecting the posterior segment of the eye. The 17 European countries include the U.K., Germany, France, Italy, Spain, Portugal, Ireland, Austria, Belgium, Denmark, Norway, Finland, Sweden, Poland, Czechia, the Netherlands, and Luxembourg.

ILUVIEN is marketed for the non-infectious posterior uveitis indication in Germany, France, the U.K., the Netherlands, Portugal, Spain, Austria, Ireland, and Italy. ILUVIEN is not approved for treatment of uveitis in the United States. DME, the primary cause of vision loss associated with diabetic retinopathy, is a disease affecting the macula, the part of the retina responsible for central vision.

When the blood vessel leakage associated with diabetic retinopathy results in swelling of the macula, the condition is called DME. The onset of DME is painless and may go unreported by the patient until it manifests with the blurring of central vision or acute vision loss. The severity of this blurring may range from mild to profound loss of vision.

The Wisconsin Epidemiologic Study of Diabetic Retinopathy found that over a 10-year period approximately 19% of people with diabetes included in the study were diagnosed with DME.