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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.

 


No Laser for Macular Degeneration…..We've Come a Long Way, Baby!

I have been in practice for about 17 years.  The present treatments for the treatment of macular degeneration are a godsend compared to the standards we used in the 1990’s.  At that time, laser treatment for wet macular degeneration was our only weapon………….and it was horrible.

State of the art treatment in the early 90’s involved using a laser to treat the abnormal vessels, or choroidal neovascularization, in wet macular degeneration.  Patients who developed the neovascular lesion would complain of decreased vision and/or distortion much as they do today.

"Blind Spot" with Laser
"Blind Spot" with Laser

Let’s say that I had a patient complaining that people’s faces were blurred out and distorted.  I established that this was due to wet macular degeneration.  My treatment recommendation would have been laser photocoagulation.  I would warn the patient of the following;  1)  if we do nothing, the large grey spot will only get bigger, if you can’t see someone’s face, you might not see the upper body if nothing is done, 2)  the laser will make your vision worse, but theoretically not as bad as if we do nothing.  We are trying to minimize the size of the area you don’t see with the laser.

That was state of the art.  We caused an immediate loss of vision by creating a dense area of non-seeing in hopes of preventing the disease from creating an even larger area of non-seeing.  State of the art, back then, offered no hope of getting better, but just containing, or minimizing vision loss.

Confused?  You should be………..imagine trying to explain this to patients.

Photodynamic Therapy (PDT) was the first time we (eye docs) could actually help people.  It was the first treatment where patients had a chance of improvement!   It was available in the mid-1990’s and was popular for several years.  It was a huge shift in the way we treated this disease.

Photodynamic therapy (PDT) treated only the “bad” abnormal blood vessels.  Unlike the laser which destroyed both healthy and diseased tissue, photodynamic therapy (PDT) with Visudyne (verteporfin) specifically treated only the abnormal, choroidal neovascularization.  No more blind spots, and, no more making the vision worse!

Intravitreal Injections of antiVEGF are now the mainstay of treatment.  As with PDT, this treatment is directed only at the abnormal, choroidal neovascularization, and destroys only the “bad” tissue.  The results, however, are better than photodynamic therapy, in that substantially more patients are helped with this treatment………..hence the popularity.

Sustained Release Technology is on the way!  In the near future, the injections are likely to be replaced with sustained release systems that are ‘injected’ once and release drug for a long time……….obviating the need for repeated injections.

We’ve come a long way, Baby! Basically, in 15 years, we have gone from causing partial blindness to offering hope and improvement of vision!

“Randy”

Randall V. Wong, M.D.
Ophthalmologist, Retina Specialist
Fairfax Virginia


How Many Intraocular Injections (eg Avastin) Are Too Many?

Intraocular anti-VEGF injections are commonly used to treat wet macular degeneration.

“Libbyextra” follows me on Twitter.  She asked, “Is there a limit to the number of injections (Avastin) a patient can have?”

There are two ways to answer this.

I do not believe there are any physical restrictions limiting the number of injections an eye can be given.  The injection requires use of a very small/thin needle placed in a portion of the eye that is avascular (without blood vessels).  The entry area is minute and is accomplished without bleeding.  The entry area is quite small and is self-sealing (don’t ask).  Healing occurs rapidly without any permanent damage or scarring to the eye.

There are physiologic considerations limiting the number of injections.  These are not related to the mechanics of the injection, but relate to the efficacy of the drug and toxicity issues.  For instance, most of the time we stop additional injections is due to the fact that no additional drug is needed; the drug did its job and nothing more needs to be done.  This is true in cases of macular degeneration and diabetic retinopathy.  More specifically, the “wet” form of macular degeneration may have dried up and no additional treatment is warranted.  Patients are monitored looking for signs of recurrence, and if found, additional injections will be prescribed.

Another reason to stop treatment; the drug isn’t working.  No reason to continue a treatment that is not working or the drug is working, but the results are disappointing.  This is common.  Many times a patient with macular degeneration comes to the office having lost significant vision in one eye.  Despite successful treatment, the vision may not return as much as we had hoped.  Often a patient will elect to stop treatment, though successful, but the visual return is disappointing.

A last reason for limiting injections would be systemic side effects.  There are rare, but serious, systemic ramifications of anti-VEGF injections.  Should a heart attack or stroke develop, further treatment should cease.

“Randy”

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

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A detached retina is potentially blinding. The retina is the light sensitive tissue that lines the inside of the eye. A retinal tear or hole usually leads to a retinal detachment. Floaters can sometimes be the earliest, and only, symptom. Many times there is little warning and a retinal detachment usually occurs without trauma.

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