Categories
Diabetic retinopathy Treatments

Iluvien Marches Forward in Europe

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.

Iluvien to Treat Diabetic Macular Edema

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.

 

Categories
Diabetic retinopathy Treatments

Study Compares Laser Treatment Against Steroids for Diabetic Macular Edema

As reported in the Archives of Ophthalmology, a 3 year study finds that laser photocoagulation is just as effective as intravitreal steroid injection for the treatment of clinically significant macular edema (CSME), aka diabetic macular edema (DME).  This DRCR.net study compared standard laser photocoagulation against intravitreal steroids given in two different strengths.

The study involved 840 eyes of 693 patients.  Over a 3 year period;

1.  the vision in laser treated eyes was better than either of the two strengths of steroid

2.  more patients initially receiving steroids needed alternate laser treatment compared to random selection

3.  75% of laser treatment group did not need re-treatment compared to the steroid group (both steroid groups had fewer people that required retreatment)

4.  the incidence of cataract was higher in the intravitreal steroid group(s)

What does this mean? First, this is a good study.  (A good study is both prospective and randomized).  A study like this seems to indicate that, when given exact circumstances, that is, patients that have exactly the same problem, laser photocoagulation is as good, or better, than intravitreal steroids.  If you had two identical eyes, both requiring treatment for diabetic macular edema, you should choose laser photocoagulation.

But this isn’t real life. This study also says that intravitreal steroid therapy is an effective way to treat patients with diabetic macular edema.  There are lots and lots of patients with diabetic macular edema that can not be treated with laser photocoagulation (sometimes the laser can not be used to treat swelling right in the middle of the macula as permanent blind spots may be created).  In these cases, I would recommend steroid treatment.

So, in some cases laser can’t be used and steroid treatment may be a better option.  Apparently, it works pretty well, but may be not as well as laser.

Link to the article.

“Randy”

Randall V. Wong, M.D.
Ophthalmologist, Retina Specialist
www.TotalRetina.com

Verified by MonsterInsights