Iluvien advances in the regulatory process for use in the treatment of diabetic macular edema in Europe.
Similar to the FDA process, Alimera announced the “positive outcome of the Decentralized Procedure (DCP)” for use in Europe. The European process now involves a national phase of the DCP where a panel of countries will need to recommend Iluvien for medical use.
Alimera Sciences’s efforts for FDA approval of Iluvien in the United States were stymied in 2011 citing concerns over safety and requesting additional clinical trials.
One of the more common symptoms of diabetic retinopathy is loss of vision due to swelling in the retina, more specifically, in the macula. This is called Diabetic Macular Edema (DME).
The macula gives us central vision. When fluid accumulates within the macula, the vision worsens.
The gold standard for treatment of DME has been laser treatment to the affected areas; however, only the areas next to, but not in, the macula can be treated. If the macula were treated directly, then permanent blind spots might develop.
This means that not all patients can be treated. Some patients have diabetic macular edema, but the source of leakage is in the central macula. These patients can not receive laser treatment.
Alternative include intravitreal injections of steroid or anti-VEGF (such as Avastin or Lucentis).
Iluvien, similar to its cousin Ozurdex (already FDA approved, but for the use of retinal vascular occlusions), is an injectable sustained release device that will release steroid for up to 36 months! Iluvien has hopes of being the first sustained release delivery system for the treatment of diabetic retinopathy.
What Does this Mean?
I am a big fan of Iluvien. I like what Iluvien represents.
Iluvien represents an emerging treatment for diabetic macular edema, a disease that clearly needs to be treated in a variety of ways. Ophthalmologists are limited in our ability to treat these patients as not all patients with this sight threatening complication are candidates for laser treatment.
Iluvien also represents hope for the future, not just for DME, but for sustained release drug delivery. While the future of Iluvien in the U.S. is beyond my scope, I am glad to see that the technology is still viable…somewhere.
While we may not see Iluvien available here in the US, perhaps its approval and use in another country will be enough for a company such as Alimera Sciences to sustain them as a business and allow them to continue their research and development of newer technologies.