Tag: Ozurdex

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Diabetic retinopathy Treatments

Ozurdex Improves Vision in Diabetic Patient | Treatment for DME

Diabetic Macular Edema Treated with Ozurdex, Randall Wong, M.D., Retina Specialist, Fairfax, Virginia 22031

Ozurdex to treat diabetic macular edema improved my patient’s vision in just 3 months!  AB first came to my office in November 2014.  He was complaining of blurry vision (in fact, he was legally blind).

AB was diagnosed with Type 1 (Insulin Dependent Diabetes Mellitus) 8 years ago.  He did not have regular eye exams.

Legally Blind

His vision in both eyes, with correction, was 20/400 at his initial visit with me in November (2014).  He had significant diabetic macular edema (also known as DME or CSME) causing the loss of vision.  He barely has cataracts.

Standard fluorescein angiography was performed.  The OCT’s from November are included below.

Treatment for Diabetic Macular Edema

I felt it best to treat him with a combination of Avastin and then Ozurdex.  Intraocular injections of Avastin were given to each eye followed by Ozurdex two weeks later.

Before Treatment with Ozurdex

Diabetic Macular Edema Improved with Ozurdex, Randall Wong, M.D., Retina Specialist, Fairfax, Virginia 22031Right
Diabetic Macular Edema Treated with Ozurdex, Randall Wong, M.D., Retina Specialist, Fairfax, Virginia 22031Left

 After Treatment with Ozurdex
2.26.RightEyeRight
Diabetic Macular Edema After Ozurdex, Randall Wong, M.D., Retina Specialist, Fairfax, Virginia 22030Left

 

What Does This Mean?

This is a remarkable case where there has been significant and rapid restoration of vision.  This case also reminds me of the many options we now have for treating diabetic macular edema….not just laser.

In this case, I preferred a combination of Avastin and Ozurdex because of the significant amount of macular edema and the dramatic loss of vision of both eyes.

I am pleasantly surprised by both the rapidity of improvement and the amount of vision improvement!

The Avastin may or may not be needed, but in my experience starts the improvement faster.  The Ozurdex will continue to treat the macular edema for up to four months.   This has the potential of reducing the number of office visits to a minimum.

The diabetic macular edema could return at any time.  I’ll need to monitor AB for any signs of recurrence.  If the swelling does recur, he may need additional injections.

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Diabetic retinopathy

New Treatments for Diabetic Macular Edema | Diabetic Retinopathy

Intraocular Injection, Randall V. Wong, M.D., Retina Specialist, Fairfax, Virginia

The treatment for diabetic macular edema has changed.  The gold-standard for treatment of diabetic macular edema has long been laser treatment, but several types of injections have become approved.

Over the past few years, I have written many articles about various new ways to treat DME.  Here’s a review of the most current ways to treat this common complication of diabetic retinopathy.

Laser Photocoagulation

This has been the “gold-standard” for treatment, that is, this is the treatment by which all others have been compared.  Laser photocoagulation, or laser treatment, was first used in the late 1970’s and was the first treatment for diabetic retinopathy.

Laser treatment works best when there are easily defined areas of leakage and the “leaks” are easy to see by fluorescein angiography.

Laser treatment works less well when there is diffuse thickening, but without obvious focal areas of leakage.  Laser treatment can not be performed when the areas requiring treatment are located in the central macula.

anti-VEGF (Avastin, Lucentis, Eylea)

These are a group of drugs which work very similar to each other.  The are known as anti-VEGF drugs because they block the effects of Vascular Endothelial Growth Factor.  VEGF is implicated in many types of retinal swelling and also in wet macular degeneration.

VEGF causes abnormal retinal vessels to leak.

Both Lucentis and Eylea are FDA approved for treating diabetic macular edema.

Ozurdex

Intraocular steroids, such as Kenalog, have been injected into the vitreous to help control diabetic macular edema.

Ozurdex, a sustained release steroid delivery system, has also been FDA approved for the treatment of diabetic macular edema in those who have had cataract surgery or are planning to have cataract surgery.

The device is delivered into the vitreous as an injection and steroid is released into the eye for about 4 months.

What Does this Mean?

With the approval of these newer products, laser treatment is no longer the gold standard for treating macular edema from diabetes.

In addition, we have several methods by which we can “treat” complicated cases, or cases where the swelling is stubborn and doesn’t leave.

There still is a role for each treatment modality.  No single treatment seems to be better than another.  It has become customary, at least in my practice, to usually combine treatments for the best outcomes!

Despite the array of treatments, it is still prudent to get early and regular dilated eye exams to limit the development of DME.

 

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My Opinion Treatments

Intraocular Drug Delivery Systems Gaining Momentum

The era of intraocular drug delivery has started.  A year ago, Allergan began shipping Ozurdex to the private sector.  As with most of these “injections,”  Ozurdex is injected into the vitreous cavity.  Ozurdex releases the steroid dexamethasone for 4-6 months.

Ozurdex for Retinal Vein Occlusions and Uveitis

The mainstay of treatment for retinal vein occlusions has been laser photocoagulation.  This sustained release drug delivery system is an alternative to laser photocoagulation.  While intravitreal injections of steroid, for example, Kenalog or Triesence, have been very successful in the past in treating the macular edema created by the RVO, I have had tremendous success using Ozurdex to treat branch or central vein occlusions.  In many cases, the results of Ozurdex are superior to laser treatment.

As of September, 2010, Ozurdex is now indicated for uveitis.

Ozurdex is given as an injection in the office setting.  I like to offer pre-operative antibiotics to, theoretically, reduce the chance of infection.  I suggest a regimen of 4x/day for 4 days before and after the procedure.  The chance of infection is comparable to that of cataract surgery.  The device is injected through a thin needle.  The needle is small enough to “seal,” or prevent leakage, without the need for sutures.

The device releases dexamethasone for several months and then dissolves.

Iluvien for Diabetic Retinopathy Nears FDA Approval

Iluvien also releases a steroid, fluocinolone.  It is marketed by Alimera Sciences and is similar to Ozurdex.  Currently, Alimera Sciences has applied for NDA (New Drug Approval) status from the FDA.

The short story, this may become available by the end of the year for the treatment of diabetic macular edema.  It, too, may be a very promising alternative to laser treatment for macular swelling due to diabetes.  Results from clinical trials indicate that Iluvien may be superior to the traditional laser treatment.

Iluvien will be injected into the vitreous the same way as Avastin or Ozurdex.  The device will reside in the vitreous and release fluocinolone, another steroid, to treat swelling due to diabetic retinopathy.

The device does not self-absorb.

Off-Label Indications

So many drugs we use routinely are used “off-label.”  This may be true for both Ozurdex and Iluvien.  It is an exciting time.

Ozurdex, while approved only for RVO, has the potential to be used for say, diabetic retinopathy, too.  This would be an “off-label” use and is certainly a legitimate use of the drug, especially if it becomes “standard of care.”

As an example, Avastin is FDA approved for certain types of cancer, but it has become standard of care for the treatment of wet macular degeneration.

Other Drug Delivery Systems in the Pipeline

  • Icon Biosciences – using the Verisome platform, this injectable “liquid” may release drug up to a year.
  • Regeneron – VEGF-Trap Eye will inhibit VEGF for the treatment of AMD, but also has potential appications for vein occlusions and DME.
  • Several other “players” include:  Genentech, MacuClear, Neurotech, Novagali,

What Does This Mean?  I didn’t try to make this an overhaul of the new devices available.  Instead, I am more interested in sparking interest in a new wave of drug delivery, that is, sustained release drug delivery to the eye.

The concepts are now well established.  Inject something directly into the eye where you expect the most effect.  This obviates the blood brain barrier.  Intraocular injections over the past few years have demonstrated the advantages of directly delivering the drugs to the target tissue.  We have found that even “old” drugs, e.g. triamcinolone, can have impressive results just by delivering the drug accurately.

The next generation of sustained release systems will include drugs such as Lucentis or Avastin.  Any drug now that requires repeated applications (i.e. injections) may have a future with sustained release technology.

It is appropriate to believe that the next level of therapeutics will include any condition which requires chronic therapy.  For instance, glaucoma medications may be combined with sustained release delivery systems.

Imagine, glaucoma treatment becomes managed by a retina specialist.  Now who would have thought?

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Diabetic retinopathy Treatments

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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