October 31, 2011 (Orlando, Florida) — A study of an intravitreal insert (Iluvien, Alimera Sciences) that releases a sustained and controlled amount of the corticosteroid fluocinolone acetonide improved visual acuity for up to 3 years in patients with diabetic macular edema (DME). The results were presented here at American Academy of Ophthalmology 2011 Annual Meeting
"With the incidence of DME on the rise, it is critical for retinal specialists to be aware of new potential treatment options for this disease, especially for patients with persistent DME. [These data are] particularly exciting, as they demonstrate that a single insert can provide rapid and sustained improvement in visual acuity for up to 36 months," said David Brown, MD, from Retinal Consultants of Houston and the Methodist Hospital, in Texas, during his presentation.
"This is a different steroid therapy involving the sustained release of a very low concentration within the eye," Dr. Brown told Medscape Medical News.
The 36-month study was 1 of 2 phase 3 clinical trials, collectively known as the FAME (Fluocinolone Acetonide for Macular Edema) study. The drug is injected into the eye in the form of a cylindrical polymer. The insert is tiny — 32 can fit on a grain of rice, Dr. Brown explained. Once injected, the drug slowly percolates out in a controlled and sustained manner.
The researchers evaluated the effects of the sustained release of low-dose (0.2 µg/day; n = 376) and high-dose (0.5 µg/day; n = 395) fluocinolone acetonide on the impaired vision caused by the deposition of fluid and protein in the eye. The results from the randomly allocated patients were compared with the results from 185 patients who received a sham injection on day 0.
The patients averaged 62 years of age, and 70% were white. They had chronic DME, with a median duration at baseline of 3 years. All patients had previously received laser treatment for DME.
The primary efficacy end point was improved best corrected visual acuity (BCVA) — by 15 or more letters from baseline — during eye-chart examinations at 24 months and at 36-month follow-up.
About 75% of the patients required only 1 implant, about 20% required a second implant, and 4% to 6% required a third implant.
The primary end point was met by 16% of the control group and by 28% of both the low-dose and high-dose groups. The improvement in the treatment groups was maintained at 36 months. Any improvement in vision was noted in 13% of the control group, 34% of the low-dose group, and in 38% of the high-dose group.
Adverse effects were "almost universal," involving cataract extraction in 80% to 87% of all patients. Elevated intraocular pressure (IOP) was also an issue, especially with the higher dose; 4% of patients required trabeculoplasty.
"The efficacy of the 2 doses was very similar, but the safety profile, especially with respect to elevation of intraocular pressure, clearly favored the low dose. Thus, the low dose is the dose being pursued for registration," Ken Green, PhD, chief scientific officer at Alimera Sciences, told Medscape Medical News.
A closer look at patients whose DME was relatively more chronic revealed an improvement in BCVA similar to counterparts with less chronic edema.
"As the DME epidemic increases, I think it's fantastic that we have another option. There is a risk of treatment concerning cataracts and IOP problems. However, the benefits we would see in these patients if this option becomes available is going to help a lot of my patients get back to work and have a sustained benefit," Dr. Brown said.
"There is a lot of evidence that steroids work for DME. I think...that this particular steroid used in this fashion works. The data look very good. We have to ask ourselves — if this gets approved — whether we can accept the 4% rate of [elevated IOP] versus the benefits of treatment," said Michael Ip, from the Department of Ophthalmology and Visual Sciences, University of Wisconsin School of Medicine and Public Health in Madison.
"I think the biggest mistake we could make is to put an implant in someone whose IOP is not monitored in follow-up," said Dr. Brown.
A decision from the US Food and Drug Administration regarding its approval is expected within weeks.
The study was funded by Alimera Sciences, manufacturer of the intravitreal insert. Dr. Brown reports relationships with Alcon Laboratories, Alimera, Allergen, Bayer Pharmaceuticals, Carl Zeiss Meditec, Genentech, Heidelberg Engineering, Molecular Partners, Novartis Pharmaceuticals, Pfizer, and Regeneron. Dr. Ip reports relationships with Allergen, Eye Technology, Genentech, NicOx, Notal Vision, QLT Phototherapeutics, Regeneron, and Sirion. Dr. Green is an employee of Alimera Sciences.
American Academy of Ophthalmology (AAO) 2011 Annual Meeting: AbstractPA045. Presented October 25, 2011.
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Cite this: Novel Eye Insert Improves Diabetic Macular Edema - Medscape - Oct 31, 2011.