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

Ozurdex Improves Vision in Diabetic Patient | Treatment for DME

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

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.

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.


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.


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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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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Iluvien Treatment for Diabetic Macular Edema

Iluvien gets closer to FDA approval for treatment of diabetic macular edema.  Earlier this week, I wrote about emerging treatments for diabetic retinopathy.  Of the group, Iluvien is now the most likely to be available.

Alimera Sciences has filed for NDA (New Drug Application) for Iluvien.  In March, the company announced the favorable results in their clinical trials for the FDA.  The NDA is the last step for FDA approval.

Iluvien Releases Steroid

Iluvien is a sustained release drug delivery system.   Similar to Ozurdex, the delivery system will release steroid after injection into the eye.   (Ozurdex is presently FDA approved for retinal vein occlusions, not diabetic retinopathy.  The makers of Ozurdex are hopeful that it may be used for diabetes.)

The steroid released by Iluvien, fluocinolone, will last for 24 months after injection.  The vehicle will remain in the eye after the drug is released.

Alternative to Present Treatments

The present treatment for diabetic macular edema involves laser treatment, anti-VEGF injections and/or steroid injections.  The laser treatment has limited applications, that is, it can’t be used in all patients and also doesn’t work as well as any of the injections.

The injections, on the other hand, don’t last long and need to be repeated.

Iluvien may obviate the need for repeated treatments and offer significant improvement in vision compared to the standard laser therapy.  With fewer injections, there is less chance of infection.

What Does This Mean? Ozurdex was FDA approved about one year ago.  The significance of Iluvien’s NDA is the validation of the advantages of intraocular sustained release drug systems.

All emerging treatments for diabetic macular edema involve injections.  All seem to offer superior treatment compared to the standard of care, laser photocoagulation.  A sustained release system for diabetic retinopathy will change the way we treat this very common eye disease.

The introduction of Iluvien is estimated to be towards the end of the year according to this week’s press release.

I can’t wait.

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Mr. Ozurdex's Vision is Sustained

“Mr. Ozurdex” is a patient in whom I injected Ozurdex® for the treatment of a branch retinal vein occlusion (BRVO).  Ozurdex, is the first sustained release drug delivery system for the eye.  It was FDA approved for the treatment of retinal vein occlusions last summer (RVO).  Allergan began marketing Ozurdex shortly after the FDA approval.

Mr. Ozurdex was given an intraocular injection in early January.  Upon his first return visit, he noted a dramatic improvement in his vision!  At the time of injection, he was legally blind.  After only 2 weeks, his vision improved enough to read.

Upon his return this week, his vision remains stable, he can still read and there are no concerns of any complications.  As with any injection of steroid, in increase in eye pressure may occur.  Happily, there is none.

Mrs. Ozurdex is Still Worried

“Mrs. Ozurdex,” on the other hand, is still not seeing any differently.  About the same time, I injected Ozurdex for treatment of a central retinal vein occlusion (CRVO). There are two types of retinal vein occlusions; central (CRVO) and branch (BRVO).

Mr. “O” had a BRVO.  The visual prognosis has always been better with a branch retinal vein occlusion.

Mrs. “O” had a CRVO.  The visual prognosis has always been much poorer with a central retinal vein occlusion.

Early Visual Results May be Misleading

I have cautioned both patients.  First, with Mr. Ozurdex, while the results are fantastic, the real question is whether or not we can sustain this improvement.  He may require another injection of Ozurdex, plain steroid, or even anti-VEGF, such as Avastin.

I have encouraged Mrs. Ozurdex to remain positive.  First, she is no worse than when we decided on the sustained release therapy, and second, the drug will be released for several more months to come.  There is still a great deal of blood and edema that can resolve, so who is to say how well she’ll fare over the next four months?

What Does This Mean? It is exciting to try a new therapy especially in an area where there have traditionally been few therapeutic options.  It is also easy to be biased, good or bad, about the results of a new treatment.

I have no way of really knowing if every patient is going to respond like Mr. “O.”  We have yet to define the perfect patient for receiving the new steroid releasing device, perhaps everyone will.

It’s too early to tell if Mrs. “O” is exhibiting a typical or atypical response to Ozurdex given her condition.

Though the FDA has given its approval, it doesn’t necessarily translate into a positive outcome.

"Mrs. Ozurdex" Came Back, She Still Can't See…Yet

Last week, I introduced “Mrs. Ozurdex,” an elderly female who has a central retinal vein occlusion in her right eye.  Several weeks ago, I implanted a sustained release steroid delivery system, called Ozurdex® (Allergan).  Ozurdex is indicated, and FDA approved, for the treatment of CRVO.

If you recall, another patient, “Mr. Ozurdex” had a branch retinal vein occlusion.  He, too, received Ozurdex.  After only two weeks there seemed to be impressive recovery of his vision!  Mrs. Ozurdex has a poorer prognosis due to the difference in the diagnosis, that is, a CRVO has more dramatic loss of vision and a poorer visual prognosis.

Still, Ozurdex is indicated to treat both.

Mrs. Ozurdex returned last Thursday.  I wanted to make sure that she was healing well after the injection and that her intraocular pressure (IOP) was within normal limits. I did not expect any change in her vision, despite Mr. Ozurdex’s shocking improvement.

Mrs. Ozurdex came to the office as happy as ever (remember “glass is half full?”).  Her eye was comfortable, her eye pressure was normal, yet there was no change in her vision.

What Does This Mean? Actually this means very little in terms of her vision.  It is too early to assess.  I needed to see her to make sure that there were no complications from the injection of Ozurdex, namely; bleeding, retinal detachment and pressure changes.  This is normal protocol.  While it would have been nice to see some change in vision, I needed to insure that there were no problems.

Much of what a retinal surgeon does is to keep status quo.  We also aim to limit complications.  While I am now satisfied we have not caused additional harm to Mrs. Ozurdex, I am still keeping my fingers crossed for her.  We should see some improvement after one month.  The drug will be released for up to 6 months.


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

"Mrs. Ozurdex" Does Not See Well

Ok, so Mr. Ozurdex is doing well.  What about Mrs. Ozurdex?

“Mrs. Ozurdex” (the names have been changed to remain HIPAA compliant) came to my office in November with complaints of sudden, painless loss of vision in her left eye.  I diagnosed her with a central retinal vein occlusion (CRVO).  Again, this is a different diagnosis, and problem, than diabetic retinopathy or macular degeneration.

There is no standard treatment for central retinal vein occlusions.  None.  There is, as with Mrs. Ozurdex, a significant loss of vision caused by loss of blood flow to the retina.  Traditionally, there is nothing that can be done to improve the vision.  The prognosis is worse than a branch retinal vein occlusion (BRVO) which plagues Mr. Ozurdex (yesterday’s post).

The Ozurdex™ system is FDA approved for Retinal Vein Occlusions.  There are two types:  branch retinal vein occlusions and central retinal vein occlusions.  The visual prognosis is much worse for the CRVO.  Ozurdex will release a steroid, over the next 4-6 months, called dexamethasone.  Dexamethasone is an old, old drug, but has been shown to be useful in treating the macular edema (swelling) present in vein occlusions.  In theory, by reducing the macular swelling, the vision may improve.

Regardless, Ozurdex was injected into Mrs. Ozurdex’s eye about 2 weeks ago.  I don’t think she will see as well as her counterpart.  Why?  The difference is in the two types of vein occlusions.  The vision has always been worse for patients with CRVO compared to BRVO.  They are almost two different diseases.

On the other hand, the Ozurdex studies showed some realistic improvement in the swelling caused by CRVO.  We have no other treatment – and I was quite forward with Mrs. Ozurdex.  As Ozurdex is reimbursed by Medicare, her insurance should cover the costs.

Mrs. Ozurdex’s right eye is normal and sees very well.  Mrs. Ozurdex’s left eye sustained the central retinal vein occlusion and is legally blind (can NOT see the big “E”).  While there is likely to be some improvement after treatment with the Ozurdex drug delivery system, there is probably going to remain a large difference between the two eyes.  Do we want to try anyway?  What do we have to lose?

She’ll be returning to the office in the next 1-2 weeks.

What Does This Mean? This is a common consideration in treating patients with retinal disease; especially patients with macular degeneration and diabetic retinopathy.  Many times patients have significant loss of vision in one eye and normal vision in the other, or “fellow,” eye.  From a practical approach, there might be improvement in the poor eye, but no, real functional improvement overall.  In other words, the moderate improvement in the poor eye doesn’t really improve a patient’s overall visual function and abilities.  Sometimes we forego treatment and sometimes we proceed.

Mrs. Ozurdex is a “glass is half full” person.  Regardless of the outcome, she’ll be happy.  If the sustained release steroid treatment works, she is rewarded with improved vision.  If it does not work, she is satisfied that she tried everything possible to help herself.

Retinal treatments, for instance, treatment for wet macular degeneration, are not to be confused with cures.  Treatments often improve or stablize vision, but rarely is there a “cure” with full restoration of vision and function.


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

"Mr. Ozurdex" is Seeing Well

Ozurdex is a new injectable drug delivery system for the eye.  Over the past few months we’ve talked about new technology and the emergence of several sustained release drug delivery systems.

About 2 weeks ago, I injected the left eye of one of my patients with Ozurdex™.  Ozurdex will release a steroid, dexamethasone, for up to 6 months.  The FDA approved Ozurdex for the treatment of retinal vein occlusions (not diabetic retinopathy and not macular degeneration).

My patient sustained a branch retinal vein occlusion to his left eye a few months ago.  The “gold standard” of treatment used to be laser treatment, but there was too much intraretinal hemorrhage to permit laser.

I told my patient about Ozurdex.  I told him that the major risk of injections is the possibility of blinding infection (endophthalmitis) which is estimated to be about 1/2000 (the same as cataract surgery).  He understood and agreed to treatment.  We gave him antibiotic drops to use prior to his return for the injection.

On injection day, in the office, his eye was cleansed with the same povidone/iodine disinfectant used in the operating room.  His eye was numbed with a Q-tip soaked in numbing solution.  This was followed by a small injection of numbing medicine.

I use a wire contraption, called a speculum, to keep the eye open.  The Ozurdex comes pre-packaged with a sharp needle for insertion.  Carefully choosing a spot at the bottom of the eye, I injected the sustained release system.  It is as big as a grain of rice.

The needle and applicator were removed.  The hole is quite small (22 gauge) and is self sealing, that is, the eye doesn’t leak when the needle is withdrawn and no stitches are needed.  He did not require a patch and was given instructions to use antibiotic drops for a few days.

He felt nothing.

Mr. Ozurdex returned this AM telling us that the vision improved in just a few days.  Today was actually 2 weeks since his injection.  The vision improved from 20/200 to 20/40.  He went from legally blind to able to read!

There is still room for improvement, but the immediate results are quite exciting.  He is very excited…and so are we!

What Does This Mean? Ozurdex is one of four sustained release systems for eye treatment.  Ozurdex is the only product FDA approved, albeit for retinal vein occlusions.  The significance of “Mr. Ozurdex” is to highlight that a new age of technology and treatment as arrived.  The product became available only a few months ago.  The treatment went smoothly.  The concept of administering injections in an office setting is “old hat.”

In the very near future, other systems will come closer to FDA approval.  Some of these systems will be releasing drugs for diabetic retinopathy and, eventually, wet macular degeneration.  Iluvien (pSivida/Alimera) is hopefully going to be approved for the treatment of diabetic macular edema.  Suromodics’ anticipates a product delivering Lucentis for sustained release treatment of wet macular degeneration.  Icon Bioscience is the latest to enter the market, now testing a system to help with healing after cataract surgery, but they too, have plans for products to treat the retina.

2010: "Year of the…Drug Delivery System?"

2010 may be the year of drug delivery systemsIcon Bioscience, Inc., (IBI) has announced their initiation of Phase 2 and Phase 3 clinical trials for an injectable sustained release system for the use in cataract surgery.  Their product, under the code name IBI-10090, will release anti-inflammatory drug for 2-3 weeks after cataract surgery.  It is hoped that this will obviate the need for the standard anti-inflammatory drops used following cataract surgery.

Similar products, namely Ozurdex™ (Allergan), Iluvien® (Alimera) and I-vation™ (Surmodics) are also sustained release platforms, but all focused on the treatment of diabetic retinopathy or macular degeneration.

Ozurdex has already been FDA approved (and thus, available to the public) for the treatment of retinal vein occlusions.  It is a sustained release system that releases a steroid, dexamethasone, to reduce macular swelling/edema following retinal vein occlusions.  I suspect it will have “off-label” uses for both diabetic macular edema and wet macular degeneration.

Iluvien also releases a steroid.  The steroid, fluocinolone, will be released for the treatment of diabetic macular edema. Their Phase 3 clinical trial should be ending soon and will be awaiting FDA approval.

Surmodics is hopeful that their I-vation system can be used to treat macular degeneration.  Previously, I wrote about their hopes to combine the I-vation delivery system with Lucentis for the treatment of wet macular degeneration.  This should, at the very least, reduce the number of intravitreal injections.  It is also testing a product that releases steroid for diabetic retinopathy.

What Does This Mean? IBI is the latest to enter the sustained release market for ophthalmic drug delivery.  There are now at least 4 companies focused (no pun intended) on extended release technology for the eye.  It is the technology that is most exciting.

All of these delivery systems are expected to be versatile.  They should be able to “carry” or deliver any number of different drugs depending upon the intended disease to be treated. For instance, while Ozurdex presently carries a steroid, it could easily carry (Novadur is the actual name for Allergan’s delivery technology) anti-VEGF drugs, etc.

While IBI is entering the market with a system for post-surgical cataract treatment, a similar product is in the IBI pipeline for the treatment of retinal diseases, such as diabetic retinopathy and macular degeneration.


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


Currently, I see patients with retinal diseases; macular degeneration, retinal detachment, macular holes, macular pucker within several different's a different arrangement, but it allows more continuous care with many eye specialists. In addition, I am very accessible via the web. To schedule your own appointment, call any of the numbers below.

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Randall V. Wong, M.D.
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Randall V. Wong, M.D.
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