FDA Approves First Long-Term Diabetic Macular Edema Treatment

The FDA has approved Alimera Sciences’ fluocinolone acetonide intravitreal implant, Iluvien 0.19 mg, the first long-term treatment for diabetic macular edema (DME) in patients who have been previously treated with corticosteroids, the company announced.

“(The) FDA approval of Iluvien…provides an important treatment option for DME patients in the US, the majority of whose DME—despite anti-vascular endothelial growth factor (VEGF) intraocular injections as frequently as monthly—is not optimally managed,” said Paul Ashton, PhD, president and chief executive officer of pSivida, which licensed the implant to Alimera in February 2005. “We are very pleased that the FDA’s approval of Iluvien is not limited…to the subset of patients with chronic DME, patients who have failed other therapies, or patients who have had cataract surgery.”

It is estimated that up to 600,000 Americans currently experience DME, an eye condition that occurs in patients with type 1 or type 2 diabetes and causes blurred vision, vision loss, and eventual blindness.

According to Alimera, Iluvien is designed to continuously release submicrogram levels of the corticosteroid fluocinolone acetonide for 36 months in DME patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.

The current standard-of-care therapy for DME requires anti-VEGF injections into the eye, though clinical studies have shown that more than half of patients are not optimally managed through that treatment.

Iluvien’s FDA approval was based on trial data that demonstrated 28.7% of patients receiving the implant experienced a statistically significant improvement from baseline in their best corrected visual acuity at 24 months, which was sustained for 3 years.

“As the role of inflammation in DME becomes more clearly understood, the use of a continuous, long-term, low-dose anti-inflammatory, such as Iluvien, is an important option for patients who have DME that persists,” said Barry Kuppermann, MD, PhD, professor and chief of the Retina Service at the University of California, Irvine, in a press release.

Alimera expects to make Iluvien available for sale in early 2015.