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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.


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Laser and anti-VEGF Best Treats Diabetic Macular Edema

Laser and anti-VEGF Best Treatment for Diabetic Macular Edema

Treating diabetic retinopathy with both laser and anti-VEGF injections may be the best way to treat patients with diabetic macular edema.  Diabetic macular edema is the most common “side effect” of diabetic retinopathy and is the leading cause of vision loss in patients with diabetes.

The results of a large, multicenter, randomized clinical trial compared several permutations of laser and the anti-VEGF drug, Lucentis.  Intraocular steroids were included as well.

To date, standard treatment, or the standard of care, includes treating the retina with laser photocoagulation to retard the loss of vision.  Not all patients can be treated with this modality and intravitreal injections of anti-VEGF and also of steroids have been found to be useful treatment for those in whom laser is not applicable (myself included).

Whether or not a patient receives laser or injections, the treatment of diabetic macular edema is akin to “weeding” a garden.  The treatments are not a cure, and just like weeding a garden, the “leakage” may be controlled for a time, but only to return.

In short, diabetic macular edema recurs and requires retreatment.

The study found that injections of Lucentis/ranibizumab followed by either prompt or deferred laser for 6 months, was superior to laser treatment alone.   The study also found that this combination was superior to a similar combination treatment with intraocular steroids.

In addition, intravitreal injections of anti-VEGF and laser (immediate +/- deferred) led to the most improvement in vision, resolution of macular edema and, over a two year period, required fewer treatments!

What Does This Mean?

Diabetic macular edema is often difficult to treat.  The number of tools we have to treat the disease was quite limited until the introduction of intraocular steroids and anti-VEGF.  Over the past few years, because of these additional modalities, we have been able to help more patients than with just laser alone.

This new study not only validates the use of anti-VEGF medications, but also hints that anti-VEGF may be superior to steroids.  More studies will tell.

Most importantly, however, the study describes a treatment regimen that leads to improvement, stabilization and reduction in the number of treatments!

This means better vision and fewer office visits, right?

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Diabetes? 4 Things You Need to Know

I tell every new diabetic patient I meet 4 things: 

  1. they are going to develop diabetic retinopathy
  2. regular eye exams prevent vision loss
  3. good sugar control doesn’t save them
  4. and their other doctors are dead wrong. 

It is a message I have developed to hammer home the idea that diabetic retinopathy can be blinding and most doctors don’t understand  how this disease affects the eyes.  There are many misconceptions about the disease.

1.  Every Diabetic Develops Diabetic Retinopathy

Diabetic retinopathy develops in most patients.  The average diabetic patient develops signs of the disease 7 years after the diagnosis of becoming diabetic.  In over 18 years of practice, I have seen fewer than 10 patients that do not have diabetic retinopathy, yet have been diabetic for over 30 years.

In my mind, this means that most, if not all, diabetic patients will get the disease.

2.  Regular Exams Prevent Vision Loss

Dilated eye exams are recommended at the time of diagnosis and then annually – even if there is no diabetic retinopathy.  Why? 

First, we don’t know when diabetes actually starts, so it is a good idea to look for disease at the time of diagnosis.  Second, diabetic retinopathy can develop while a patient is still 20/20.  The goal is to catch the disease and treat, while the vision is still perfect.  We don’t want to wait until there is decreased vision.  So, regular examination prevents vision loss.

3.  Good Sugar Control Does Not Prevent the Disease

This is the biggest myth.  While it is true that the severity of the disease is may be limited with sugar control, most people (and a lot of doctors) believe that good control of the blood sugar prevents diabetic retinopathy.

It does not.

4.  Doctors Really Don’t Know

I am constantly surprised that many doctors don’t know that every patient with diabetes, regardless of the vision (good and bad), need a dilated eye exam every year.

Many doctors don’t know that a patient with excellent vision and/or good sugar control can still develop diabetic retinopathy.

What Does This Mean?  If the development of diabetic retinopathy is inevitable, or at least highly likely, then the patient can’t be blamed for NOT taking good care of themselves. 

My message removes the blame.  Do you enjoy being contantly reminded when you are making mistakes?  Of course, not.  Would you keep going to the doctor if every time you were being told you were ugly?  Noone likes to be nagged or blamed.

My message also lets patients know that they can be rewarded by maintaining regular visits…we can prevent significant vision loss, and most cases are able to prevent any vision loss at all.

Have a great weekend.

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Combination Injections for Diabetic Retinopathy

Injecting both Avastin and a steroid injection can be a useful way to treat stubborn macular edema from diabetic retinopathy.  While both can be used alone to treat macular swelling in diabetic patients, the combination is sometimes considered as an alternative.

Traditional Laser

The gold standard has been to treat diabetic macular edema with laser treatment.  This has been a very effective means of achieving visual stability, that is, preventing further loss of vision.  About 20-25% of patients do improve.

Swelling That Doesn’t Go Away

Many patients do not improve with laser.  Their vision doesn’t improve and the macular edema does not resolve.  Usually additional laser won’t help as the persistent swelling is due to leaky “microaneurysms” located in the center of the macula.  Treating these centrally located areas with laser treatment would create permanent blind spots in the central vision.

“Plan B”:  Steroid or Avastin

Alternatives to the laser treatment include intraocular injections of steroid (e.g. Kenalog/triamcinolone acetonide) or anti-VEGF medications (e.g. Avastin, Lucentis).  Many times a single injection of either can improve both the vision and the macular edema.

“Plan C”: Steroid and Avastin

Once in a while, I have patient that doesn’t respond to either a single injection of steroid or anti-VEGF.  The next alternative is to alternate treatments with the other drug.  For instance, if I start with the steroid and get minimal or no response, I’ll usually recommend that the next injection be Avastin, or something similar.

Occasionally we have to alternate treatments several times before getting a satisfactory response.

What Does This Mean? The use of anti-VEGF and steroids is not new.  These drugs have been used “off-label” for the treatment of diabetic macular edema for several years.  Remember, though “off-label,” it is standard of care.

The recent report of success using a combination of Lucentis and laser treatment for diabetic macular edema underscores the need for an adequate treatment for this common complication of diabetic retinopathy.

In a few years, I predict that laser will be used only sparingly for the treatment of diabetic retinopathy and that the mainstay of treatment for diabetic macular edema will be more drug based.

We have come a long way in successfully treating diabetic retinopathy and preserving vision.

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Vitreous Hemorrhage and Diabetes

A vitreous hemorrhage can result in sudden, painless loss of vision.  In patients with diabetes, the cause may be due to either a posterior vitreous detachment (PVD) or proliferative diabetic retinopathy (PDR).  Remember, the proliferative phase of the diabetic retinopathy means that there are areas of neovascularization (abnormal blood vessel proliferation) on the surface of the retina.

In cases where a diabetic patient is diagnosed with a vitreous hemorrhage, my job is to ensure that the cause  is not due to a retinal tear or a retinal detachment.  This can be done by dilating the eye and examining.

You Can’t See Out and I Can’t See In

Sometimes there is so much blood I can not see much or any of the retina.  In these cases, we perform an ultrasound of the eye to make sure the retina is attached.

Sometimes, an ultrasound can locate a retinal tear.  If there is no retinal tear, or retinal detachment, then I am pretty sure that the vitreous hemorrhage is due to the proliferative diabetic retinopathy.

Fragile Vessels

Neovascular vessels are very fragile and may easily break open and bleed.  This may occur with or without straining.  The blood can fill the vitreous cavity causing sudden “loss” of sight.  Vision is “lost”  (not permanently) due to physical blockage of light.

Vitreous Hemorrhage, Proliferative Diabetic Retinopathy, Randall V. Wong, M.D., Fairfax, Virginia.
Vitreous Hemorrhage

Bleeding in the vitreous is benign.  It causes no damage to the vision or to any part of the eye.  On the other hand, as it physically blocks light, patients don’t see well.

Sometimes it is Best to do Nothing

Usually, when I am sure the bleeding is due to diabetic retinopathy, I recommend a period of doing nothing.  We watch and wait.  In doctor lingo, we are observing.

Patients Tire of Not Seeing

After a few weeks, or sometimes longer, we may decide to operate to remove the blood.  Sometimes the blood absorbs on its own and sometimes it doesn’t.  At some point, patients with non-absorbing blood in the eye become tired of the prolonged decreased vision.  A vitrectomy is then scheduled to remove the blood.

What Does This Mean? The sudden loss of vision can be devastating for anyone.  In cases when the loss of vision is due to a vitreous hemorrhage, we need to assess the threat of permanent vision loss due to other causes such as a retinal tear or retinal detachment.

If the eye is stable, that is, we can safely observe, it is sometimes tough to reassure patients that while they just “lost” their vision, the best idea is to do nothing!  Their “lost” vision is temporary.

I often will have a patient return in a short week or two to reassess and help relieve anxiety.

Patients with proliferative diabetic retinopathy, if you remember, will require laser treatment (pan-retinal photocoagulation, aka PRP) to reverse the neovascularization.

While we are waiting for the hemorrhage to clear, at the same time we are mindful that laser treatment is ultimately needed.  If the vitreous hemorrhage clears by itself, laser can be applied in the office.  If we end up operating, the laser can be applied at the same time as the vitrectomy.

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Sustained Release; Ozurdex Now Treats Diabetic Macular Edema?

Ozurdex, a sustained release drug delivery system,  may soon be used to treat diabetic macular edema. The sustained release intravitreal implant has been tested, with favorable results, for possible use in treating the common retinal swelling caused by diabetes. Results were published recently in the March issue of the Archives of Ophthalmology.

Ozurdex was FDA approved for the treatment of retinal vein occlusions last year. It was the first sustained release drug delivery system for the eye. It releases dexamethasone, a well studied (i.e. old) steroid.

Diabetic macular edema is a common complication of diabetic retinopathy and is the most common cause of lost vision due to diabetes. The most common treatment for DME has been laser photocoagulation.

Over the past years, small anecdotal studies have implicated the favorable use of intraocular injections of either steroid or anti-VEGF medications as an alternative method for treating diabetic macular edema.

It is not uncommon for retinal specialists to turn to intraocular injections as a means to help control the retinal swelling as a first line of therapy or to augment the laser treatment.

The small study involved 171 patients and tested two strengths of Ozurdex along with placebo (i.e. nothing). Both strengths of the Ozurdex group showed improvement, and more importantly, improvement that was sustained for at least 6 months compared to the sham (placebo) group.

What Does This Mean? The results are expected. It is not surprising that a sustained release system shows improvement when the intraocular injections (shorter acting) showed improvement, too.

What is significant is the that the technology continues to move forward and that newer “treatments” continue to emerge based upon this sustained release technology.

Whether or not Ozurdex is going to be used for diabetic macular edema depends upon Medicare. If Medicare is going to reimburse (that is, pay) for Ozurdex in diabetes then docs may start using it routinely.

“Off-label” indications are really not the issue in this case, but the cost of Ozurdex is the issue.  The cost of Ozurdex is about $1300.

If insurance companies do not reimburse Ozurdex, it is too expensive for patients to be willing to cover the expense out of their pocket.

Keep your eye out for news on Iluvien (pSivida/Alimera Sciences). Iluvien is expected to be presented to the FDA for approval for …treatment of diabetic macular edema. Iluvien is a sustained release drug delivery system that releases fluocinolone…a steroid.

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Blurry Vision and Other Symptoms of Diabetes

Blurry vision is a common symptom of diabetes.  Other diabetic symptoms include excessive thirst, frequent urination, weight loss and fatigue.  Most of the symptoms are due to the lack of insulin which secondarily allows the sugar levels to sky rocket out of control.  This sets up sugar gradients that cause imbalances in water distribution in the body and in different organs.

One note, the blurry vision as a symptom of diabetes is not caused by the same mechanism as blurry vision from diabetic retinopathy.

“Osmolarity” – Water Follows Sugar

The fancy term for this concept is “osmolarity.”  One way to think of osmolarity is that sugar attracts water, or, water goes where the sugar goes.

Insulin Takes Sugar From the Blood and Delivers it to Your Cells

When we eat, food is broken down and absorbed into the bloodstream.  The sugars, the little energy units that serve as fuel for our cells, can not get into the cells without insulin.  Stated another way, insulin lowers blood sugar.

When the supply of insulin is insufficient, as in diabetes, sugar levels in the blood rise.  Remember the law of osmolarity, if the sugar stays in the blood, it draws water out and away from your cells and into the bloodstream.

Your body becomes dehydrated as the water is drawn into the blood stream.  This is a relative increase in the fluid volume of the blood, the kidneys then make more…urine.  The relative dehydration also explains the excessive thirst.

The frequent urination, and especially, frequent urination at night, are very common symptoms of diabetes.  Since the high sugar levels are constantly drawing water out from the cells, the body is constantly dehydrated causing extreme thirst.

Weight Loss

There are two reasons for the weight loss.  One cause is the loss of  water weight caused by the frequent urination.  This is similar to a wrestler trying to “make weight” by becoming dehydrated.  The second reason for weigh loss is the loss of body fat and muscle.

The body uses sugars, fat and then muscle, in that order, for energy sources.  If there is insufficient insulin, sugar can not be utilized as an energy source and the body then starts to burn fat and muscle, ergo, you lose weight.

Blurry Vision

This explanation is a bit more involved, but bare with me.

Sugar enters the natural lens in the eye.  Sugars are changed to “sorbitol” inside the lens.  Sorbitol can not exit the lens as easy as sugar, but sorbitol, too,  like sugar, attracts water.

The end result?  The lens takes on water and changes it’s focusing powers …causing blurry vision.  Again, this is distinct from the vision changes associated with diabetic retinopathy, a separate problem.

Correcting Blood Sugar

Taking insuling or oral medications causes the blood sugar to decrease.  The cells of your body can now retain water, the dehydration ceases and the excessive thirst and frequent urination disappear.

Sugar can now be metabolized by the cells, preserving fat and muscle, and the weight loss and energy returns.

As the sorbitol decreases in the lens, the relative water content decreases, and the  normal focusing power of the lens returns…vision improves!  This is why diabetics should only get examined for glasses when the sugar is at usual levels and controlled.

What Does This Mean?  There are two types of vision “loss” from diabetes.  The blurry vision as a symptom is temporary and reversible.  The second may develop long after the diagnosis if diabetes is made.  Vision loss, the principle “focus” of this blog, from diabetic retinopathy is less reversible and is a result of a disease rather than a symptom.

So, blurry vision may be a sign of high sugar.  If diabetic, you may develop the disease, diabetic retinopathy.

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It's Not What You Look At, It's What You Look For

Making a diagnosis can be difficult.  Diabetic retinopathy and macular degeneration are easy to diagnose, but you have to know to look for it to see it.  The diagnosis then becomes pretty obvious.  Knowing what to look for is essential to making a correct medical diagnosis.  Retinal disease, such as ARMD and diabetic retinopathy, is easy to diagnose as we can also “see” the eye.

I just read about a 59 year old male who had all the common symptoms of diabetes for several years, yet his doctor treated each symptom separately.  His weight loss was treated with high calorie supplements, his frequent urination was treated as a prostate problem and his multiple nighttime trips to the bathroom were treated with sleeping meds.

He switched doctors and was diagnosed with Type II diabetes.

Just Browsing, But Not looking

Was his first doctor stupid?  Not necessarily, but he failed to “look” for diabetes.  He failed to look for the one diagnosis that could bring all the symptoms together.  He didn’t look for a common denominator.  Had he “looked” for diabetes, he would have checked sugar levels, and then, solved the puzzle.  This doctor was similar to a shopper who is “just browsing.”

Problem Oriented Thinking

The second doctor practiced ‘problem oriented’ medicine.  He was able to find the common denominator of all the “problems” and then knew what tests to order to prove himself correct (namely, serum glucose and hemoglobin A1C).  This doctor was the shopper that went shopping with a finite list of items.

Diabetic Retinopathy and ARMD is Even Easier to Diagnose

Diabetic retinopathy and macular degeneration are even easier to “see.”  Why?  Because I can also “look” at the eye and determine the presence, or absence, of either disease.  Sometimes it takes no testing.

I can rely on my examination for establishing a diagnosis because I, too, know what to “look” for.

In diabetics, I look for blood, microaneurysms, macular edema, exudates, neovascularization and retinal detachments.  Having some of these findings will establish the diagnosis.

So, too, in macular degeneration.  I look for characteristic scarring of the macula, bleeding underneath the retina, drusen and leakage, etc.

Most of the time, if not always, we are able to make a diagnosis by direct examination.  Testing can confirm our suspicions.

What Does This Mean? Because eye docs are able to directly visualize most aspects of your eye, we’re able to tell you with a high degree of certainty, especially with diabetic retinopathy and macular degeneration, if you have the disease or not.  There is usually no beating around the bush.

If there is any doubt, additional testing may be helpful.  To you, the patient, we can offer assurance about the state of your retinal disease.

We know what to “look” for and what to “look” at.

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Macular Degeneration Treatment and the Blood Brain Barrier

The retina is part of the central nervous system.  Delivering medicine into the central nervous system, or to the retina, by traditional means has historically been very difficult; hence the popularity of intraocular injections.  By bypassing the blood-brain-barrier (or blood-retina-barrier), drugs are now effectively delivered to the “target” tissue.

The usual methods for treating a disease, be it an infection, hypertension, or even diabetes, is to take a pill.  The pill is dissolved in our stomach and the medicine is absorbed into the bloodstream.  The bloodstream delivers the pharmaceutical to the target tissue… and bingo! the drug does its thing.

More direct methods require intravenous (IV) delivery for the medicines.  A drug is delivered directly into the bloodstream via a vein.  This delivery method bypasses the digestive system and does not require absorption.  This method is great for delivering higher doses of medication into the body and for delivering drugs that get altered when swallowed.

In the eye, and in the brain, drugs that have been either absorbed, or administered via an IV, get trapped within the blood vessels and are not able to diffuse into the eye or brain.  This is called the “blood-brain-barrier.”  Essentially, drugs do not get to the brain/retina by normal methods due to the uniqueness of the blood vessels in the central nervous system and the eye.

To beat a dead horse – This is why we are using intraocular injections to deliver steroids and anti-VEGF medications to treat macular degeneration and diabetic retinopathy.  These drugs do not get into the eye via the bloodstream.  By injecting directly into the eye, we bypass the blood-retina-barrier and put the medicine right where we want it.

What Does This Mean? This is one large reason why there are no pills or medicines to treat macular degeneration or diabetic retinopathy.  We can’t get the medicine to the retina.  The idea of intraocular injections is relatively new, but has gained wide acceptance as it is highly effective (works better than anything else), is convenient (done in the office), is safe…and is painless.

By directly injecting agents into the eye, we are able to treat the retina with “old” drugs.  Steroids are certainly not new, but we have discovered many “new” uses for treating retinal disease simply because we can get the drug to the tissue.

The next generation of injections will be the sustained release drug delivery systems that I talk about once in a while.  It shares the same theme as the introacular injections; it bypasses the blood-retina-barrier.

A1C Now Used to Diagnose Diabetes

The American Diabetes Association now recommends basing the diagnosis of diabetes upon the hemoglobin A1C levels and not on fasting glucose tests.  In addition, an A1C of less than 7.0% should be the target for glucose control.  How with this impact the treatment of diabetic retinopathy?

The change in recommendations stems from the fact that the A1C blood test is an easier, and faster, test to run than measuring a fasting plasma glucose and an oral glucose tolerance test.  Both tests require overnight fasting for accuracy; that is, it relies on patient compliance.  The A1C does NOT require overnight fasting.

A1C measures the average blood glucose levels for the period of up to 3 months and was previously used just to measure sugar control over time, but now, it is recommended to be used for diagnosis;

  • A1C  of 5%  – no disease
  • A1C of 5.7 to 6.4% – likely prediabetes
  • A1C > 6.5% – likely diabetes

The ability to diagnose the test using A1C guidelines now means that the diagnosis of diabetes can be made earlier.  Earlier detection (diagnosis) may mean a greater chance of  “curing” type II diabetes by making lifestyle changes earlier.

What Does This Mean? The ability to diagnose and treat this disease now has some firm, “black and white,” guidelines.  More patients will be detected and at an earlier age.  Therapy and education may be instituted earlier.  For instance, patient education regarding diabetic retinopathy may be instituted sooner.  In this respect, more patients will be “saved” over the long run.  In theory, patients will be directed for eye exams before the retinopathy begins.

It is also likely, that with tighter sugar control (i.e. good A1C levels), diabetic eye disease will progress slower.  We’ll see.


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

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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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