Iluvien Gets Closer to FDA for Diabetic Retinopathy

Iluvien Gets Closer to FDA for Diabetic Retinopathy

Iluvien, an injectable drug delivery system for the treatment of diabetic retinopathy, gets closer to becoming FDA approved.  Alimera Sciences announced this week that the FDA has given the investigational device “Priority Review” status.  Priority Review status hastens the chances of full FDA endorsement from 10 months to 6 months.

What is Iluvien?

Iluvien is a sustained drug delivery system that is injected into the eye, specifically into the vitreous.  Similar to Ozurdex, Iluvien will release steroids into the eye, in this case, up to 3 years.  Alimera Sciences anticipates that this drug delivery system will be approved for treating diabetic macular edema, a very common malady that affects those with diabetic retinopathy.

Current Treatment for Diabetic Retinopathy

This approach is novel in that it will be the first pharmaceutical agent, or medicine, to be FDA approved for diabetic macular edema.  To date, only laser treatment to the retina is approved.

On the other hand, retina specialists like myself, have been using intravitreal injections of Avastin or steroids for several years as an acceptable alternative to laser.

Other Drug Delivery Systems for the Eye

Ozurdex was released just over a year ago (summer 2009) for the treatment of retinal vein occlusions.  Vein occlusions, another type of retinal disease, can cause significant loss of vision.  I have had tremendous results using Ozurdex, especially for patients with branch retinal vein occlusions.

There are several other injectable systems under development, not just for diabetes, but for macular degeneration and other eye diseases as well.

What Does This Mean? This is significant news in several ways.  First, there is a new therapy emerging for the treatment of the most common complication of diabetic retinopathy.  This is a boon for physicians like myself who are tiring of the limits of laser photocoagulation.  This system has the promise of making visual improvements not possible with laser.

There is a revolution just beginning in the management of eye disease.  These injectable drug delivery systems will forever change our ability to treat, not just retinal disease, but eye disease overall.

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  • elizabeth machado
    Posted at 16:55h, 01 September Reply

    Dr randall wong
    I am very happy with the good news.
    hope this new treatment could be available in my country too.
    I leave in brazil,and strugling with diabetes retinophaty and now having avastin shots for macular edema.
    my best regard
    Elizabeth Machado

    • Randall V. Wong, M.D.
      Posted at 12:27h, 03 September Reply

      Dear Elizabeth,

      It sounds as though you are in good hands. Iluvien may be available very soon! Hang in there!

      BTW – another possibility is to consider using Ozurdex, if available. Ozurdex releases a steroid, too, for about 4 months.


  • Chris
    Posted at 06:29h, 04 September Reply

    Dr. Wong
    What is the noral dosage for the Ozurdex for diabatic people with DME? Many thanks in advance

    • Randall V. Wong, M.D.
      Posted at 06:44h, 04 September Reply


      Good morning.

      Ozurdex is only available in one “strength.” Ozurdex delivers 0.7 mg of the drug dexamethasone.

      We don’t know for sure, but the device releases drug for about 4 months.

      Thanks for your question!


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    Posted at 20:11h, 10 January Reply

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