Iluvien (fluocinolone acetonide intravitreal implant), an injectable implant for diabetic macular edema that was approved by the U.S. Food and Drug Administration (FDA) on September 26, 2014, is now widely available in the United States.
In diabetic macular edema, or DME, fluid leaks into an area in the middle of the retina known as the macula, which is responsible for providing crisp vision and fine detail. The macula swells and vision blurs. DME affects approximately 750,000 Americans and about 10% of people who have diabetic retinopathy (which occurs when diabetes damages tiny blood vessels in the eye’s retina, the light-sensitive tissue at the back of the eye).
Iluvien — a tiny tube containing the corticosteroid drug fluocinolone acetonide — is approved to treat those with DME who have previously been treated with corticosteroids without experiencing a clinically significant rise in intraocular pressure (the pressure inside the eye). Treatment involves a doctor injecting the implant into the back of the eye, where DME typically forms, using a 25-gauge needle. Each implant is designed to release the medicine for 36 months.
The approval of Iluvien was based on data from clinical trials indicating that, 24 months after receiving the implant, 28.7% of people experienced improvement in visual acuity (sharpness of vision). Those receiving Iluvien also experienced a statistically significant improvement in visual acuity by week 3 compared to a control group, which was maintained through the end of the study at 36 months.
The most common side effects of Iluvien include cataracts and increased intraocular pressure.
The cost of each three-year treatment with Iluvien is $8,000. The manufacturer offers programs to subsidize or eliminate the cost of the drug for people without insurance and those with insurance who meet certain criteria. For more information, visit the patient support page.