FDA Approves First Long-Term Diabetic Macular Edema Treatment

Article

The FDA has approved the intravitreal implant, Iluvien 0.19 mg, as the first long-term treatment for diabetic macular edema.

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.

Related Videos
Diabetes patient turn knob on end of insulin pen and dial up correct insulin dose for injection. Scale window on pen syringe showing number of units dose. Medical equipment is easy to self injection - Image credit: Orawan | stock.adobe.com
Laboratory test tubes and solution with stethoscope background | Image Credit: Shutter2U - stock.adobe.com
Image credit: Andrea Izzotti
Inflation Reduction Act is shown using the text and the US flag - Image credit: Andrii | stock.adobe.com
Pharmacy Interior | Image Credit: Tyler Olson - stock.adobe.com
Patient with diabetes testing blood sugar levels
Male pharmacist selling medications at drugstore to a senior woman customer | Image Credit: Zamrznuti tonovi - stock.adobe.com
Pharmacist assists senior woman in buying medicine in pharmacy - Image credit: Drazen | stock.adobe.com
Pharmacy, medicine and senior woman consulting pharmacist on prescription. Healthcare, shopping and elderly female in consultation with medical worker for medication box, pills or product in store - Image credit: C Daniels/peopleimages.com | stock.adobe.com
© 2023 MJH Life Sciences

All rights reserved.