Alimera Sciences Says Iluvien Effective at 3 Years

Avastin and Lucentis Are Equally Safe, Too.
May 10, 2011
Do Avastin Injections Hurt?
May 31, 2011
Show all

Alimera Sciences Says Iluvien Effective at 3 Years

Iluvien, a sustained release drug-delivery system for the treatment of diabetic macular edema, may be getting closer to possible FDA approval.  The parent company, Alimera Sciences has resubmitted additional safety and efficacy data as requested by the FDA last year.  The FDA requested that they be given data extending for a 3 year period instead of the 2 years in the new drug application.

Iluvien is Effective for Diabetic Macular Edema

Iluvien may be an effective new treatment for diabetic macular edema.  In theory, patients that require treatment for this common complication of diabetic retinopathy may receive an injection of Iluvien.  Iluvien will then release a steroid over several months and the company is trying to prove that it provides a benefit to the patients, in this case, the vision improves.

Such safety and efficacy data were presented recently to the public at a large ophthalmic meeting in FL last month.  The company has also submitted this data to the FDA (Food and Drug Administration).

About 30% or More of Patients Improve with Iluvien

In short, the company performed two large clinical trials, the so-called FAME study showed that about 33% of patients  receiving the implant noted an improvement in vision.  Of significance is that this improvement, according to the company, was present after 3 years.

Last year, the FDA also asked for a review of the manufacturing process of Iluvien, but I am not aware of any specific elements that were made public.  These, too, have been addressed.

What Does This Mean?

About a year ago, Alimera Sciences submitted the new drug application (NDA) for it’s proprietary intraocular drug delivery system for the treatment of diabetic macular edema (DME).

The NDA is the last step to acheiving FDA approval for a new drug.

Last December, the FDA failed to approve the NDA, but, instead requested more data about the efficacy (how well a drug works) of Iluvien.  This was provided this Spring.

So…we continue to wait.  There should be some decision made this Fall, but my guess will be that it is favorable.

If you remember, Ozurdex, the first sustained release intraocular drug delivery system was approved for treatment of retinal edema caused by retinal vascular diseases.

It may be that a second such device may be shortly approved for the treatment of diabetic retinopathy.  While this further endorsed the sustained release technology, it will be a breakthrough that allows significantly more people to be helped that presently have few options.

 

Enhanced by Zemanta
Comments
  • George May 22, 2011 at 4:23 am

    Hi Doc. Great news.
    I was reading about the iluvien and I guess the delivery vehicle stays in the eye forever (i.e. it is not biodegradable). What if a patient took two injections (i.e. three years after taking the first one)? That would mean two delivery vehicles will remain in the eye. Are there any side effects of having these delivery vehicles remaining in the eye forever? Many thanks Doc.

    • Randall V. Wong, M.D. May 22, 2011 at 4:43 pm

      Dear George,

      You are correct, the “vehicle” does not dissolve, unlike a similar product “Ozurdex.”

      This may be a hurdle to widespread acceptance of Iluvien. The vehicle is quite small and really shouldn’t be a problem, even with several in the eye, but I’m guessing the idea itself is going to be hard to sell.

      Nice observation!

      Randy

      Randy

  • George May 23, 2011 at 7:22 am

    Hi Doc.
    I noticed while searching the internet that a drug(eye drops) by the name mecamylamine has been shown to be effective in treating DME. Any more details you can add please. Is it approved by FDA? Also, does this drug comes under different brand names. Many thanks

  • mrargaret fenn May 23, 2011 at 9:17 am

    hi doc, my husband has diabetic retinopathy, has been diabetic for 19 years type 1 insulin. has had several doses of laser treatment. the last treatment he had on his left eye was scatter laser we were told i think they saidit was a 1000 shots. however immediately this was done my husband was blind in that eye and now only has peripheral vision, prior to that he had perfect 20 x 20 vision. he has now been told that he needs laser treatment to his right eye which has leakages causing bleeds, he is very scared of having anymore treatment, although he is under St Thomas Hospital now and it wasnt them that caused the blindness. any advice would be appreciated. thankyou

    • Randall V. Wong, M.D. May 28, 2011 at 6:17 pm

      Dear Ms. Fenn,

      There are two reasons to treat a retina with laser; one for the “leakage,” and the other for proliferative diabetic retinopathy.

      The scatter is used only for the proliferative diabetic retinopathy and, with that diagnosis, is the possibility of true, complete blindness. The scatter laser is intended to halt this process. Is this what has been recommended for your husband’s other eye?

      If so, I would recommend that any swelling/leakage be controlled first, as the scatter, though preventing complete blindness, may make the swelling worse.

      I know this is confusing. Sorry.

      Randy

  • Mary September 1, 2011 at 2:58 pm

    Nice article. I heard the delivery of Iluvien is problematic in RVO, will this be an issue in DME then?

    • Randall V. Wong, M.D. September 4, 2011 at 9:30 pm

      Dear Mary,

      In what way do you mean that “delivery of Iluvien is problematic?”

      Manufacturing? Insertion?

      Write back.

      r

  • Mary September 6, 2011 at 2:17 pm

    I heard someone mention at a meeting that there was some problems with the insert and that a new insert may be necessary.

    • Randall V. Wong, M.D. September 7, 2011 at 5:00 pm

      There have been some rumors and speculation about manufacturing issues so says the FDA reports.

      We’ll see.

      r

  • Post a comment

Trackbacks
  • FDA Denies Approval of Iluvien, Not Safe Enough November 15, 2011 at 12:03 pm

    […] Iluvien is a sustained release drug delivery system that releases a steroid into the eye for the treatment of diabetic macular edema.  Alimera received the denial late last week in a letter from the […]

  • Iluvien to Treat Diabetic Macular Edema May 9, 2012 at 11:49 am

    […] Iluvien continues to make progress outside the US for treatment of macular edema due to diabetic retinopathy. […]

  • […] Alimera Sciences states that Iluvien (sustained release of fluocinolone) will release its drug for up to 3 years. […]