The FDA, finally, after three rejections, has given approval to Alimera Sciences‘ (Alpharetta, GA) ILUVIEN drug eluting eye implant for treating diabetic macular edema (DME). The device, about the length of, but much narrower than, a grain of rice (3.5 mm x 0.37 mm), is injected intravitreally using a syringe-like device. Once deployed, the device slowly releases fluocinolone acetonide (FAc), a corticosteroid, for the next three years to control inflammation within the eye and help slow down the effects of DME. The 25-gauge needle used during implantation is small enough for the wound to heal on its own following the procedure. The delivery technology was licensed from pSivida (Watertown, MA) and Alimera conducted the trials that resulted in the approval.
“FDA approval of ILUVIEN, our third FDA-approved product for retinal disease, provides an important treatment option for DME patients in the U.S., the majority of whose DME, despite anti-VEGF intra-ocular injections as frequently as monthly, is not optimally managed. ILUVIEN’s clinical trials showed that ILUVIEN can actually reverse vision loss in many DME patients. Another advantage of ILUVIEN over existing therapies is that a single injection provides sustained therapy for three years,” said Paul Ashton, Ph.D., president and chief executive officer of pSivida, in the announcement.
Take a look at this video that explains the ILUVIEN and how it’s implanted:
Here’s the actual implantation procedure that the squeamish among us might want to skip:
Product page: ILUVIEN…