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Tag Archives: Vascular endothelial growth factor

Eylea As Good As Lucentis

Last month, the FDA approved Eylea (VEGF-Trap, aflibercept) for the treatment of wet macular degeneration.  The new drug does not need to be injected as often as Lucentis, yet it seems that the visual improvement is the same; that is, fewer injections yield similar improvement in vision…for the first year of therapy.

Keep in mind that we are always interested in a drug’s ability to improve vision, and sustain these improvements.

Eylea Improves Vision and is Sustained

This week, results from patients receiving these eye injections for a second year were reported.  It was disclosed that little benefit was seen between the two drugs for the second year of treatment, i.e. the visual results were sustained and comparable.

During the second year of treatment, both drugs were given “as needed” in contrast to the first year with regimented dosing;  monthly injections for Lucentis and bimonthly for Eylea.

Stock Drops After News

Regeneron’s stock (Regeneron manufactures Eylea/aflibercept) apparently plummeted after the news.  Wall Street seems disappointed that the the new drug may not be as cost effective nor as convenient as initially hoped.

What Does This Mean?

I think this validates the new drug.  The study confirms that visual improvement is indeed achieved with Eylea and is also maintained.

Clearly, I expect that Eylea will yield the same visual results over the first year of treatment, yet requiring fewer injections.  This means fewer trips to the doctors, fewer diagnostic texts, fewer rides from family and friends.

The data recently presented only confirms that Eylea works.  Remember, few drugs, including Lucentis, are actually used in the same fashion as when they were FDA approved, that is, we should be happy that Eylea improves vision for the 2nd year…nothing more.

More convenience, equal results, cost savings (from fewer office visits) can be translated into improved compliance (patients willing to continue treatment) and that also means MORE patients may be willing to undertake treatment!

This is exciting!

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Still No Iluvien

FDA Denies Alimera Sciences' Iluvien for Treatment of Diabetic Macular Edema


Alimera Sciences fails to get FDA approval for Iluvien.  Iluvien is a sustained release drug delivery system that releases a steroid into the eye for the treatment of diabetic macular edema.  Alimera received the denial late last week in a letter from the FDA.

Implant Too Risky

In short, the FDA still has concerns about the safety of the new drug.  Original concerns about cataract formation and IOP (intraocular pressure) still remain despite additional safety data submission.  The FDA has stipulated additional clinical trials must be performed to answer the risk/benefit concerns.

Iluvien was anticipated to be the second sustained release drug for the treatment of a retinal disease.  The first drug, Ozurdex, was approved by the FDA for treatment of retinal vascular occlusions (e.g. CRVO, BRVO).  Ozurdex received FDA approval in 2009.

Docs Need Options for DME

Iluvien was to be indicated for the treatment of diabetic macular edema, a very common complication of patients with diabetic retinopathy.  Typically, patients receive laser treatment as a first line treatment, but alternative treatments have been long needed as laser can not be performed in everyone.

Intraocular injections of steroid or anti-VEGF medications such as Avastin or Lucentis, have also been used to treat diabetic macular edema over the past several years, but the use of these agents is “off label.”

The sustained release device is injected into the eye and will release a steroid, fluocinolone, for up to 36 months.  Shorter acting steroid injections have demonstrated favorable results and it was anticipated that a sustained release system might offer a realistic benefit of better drug levels and little need for reinjection.

What Does This Mean? Certainly, I am not in a position to remark about the FDA decision. There are many patients in whom laser is not an appropriate treatment.  There is no FDA approved alternative.  Ophthalmologists, including myself, have been using short acting steroids and anti-VEGF injections to treat these “no laser” patients.

Moreover, Iluvien would have validated sustained release drug delivery systems.  Ozurdex was first and Iluvien would have been the second delivery system designed for injection into the vitreous.

A second approved product, regardless of indication, would have been a significant endorsement for injectable sustained release systems.  Sustained release devices for macular degeneration (sustained release drug delivery of anti-VEGF), post-operative medications and glaucoma seem logical.



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October is the AAO Meeting

We are leaving for Orlando, FL in a few days to attend the American Academy of Ophthalmology meeting.  It is our industry’s largest meeting of the year…worldwide.

The meeting has become so large that only a certain cities can host the event;  Atlanta, Dallas, Chicago, San Francisco, Las Vegas, New Orleans and Orlando.  Literally tens of thousands of people will attend;  doctors, administrators, technicians, vendors, etc.

This will be the largest collection of eye related people anywhere in the world.

New scientific discoveries will be announced, new products for patients will be displayed, advanced technology will be highlighted, and hundreds of courses will offered. It’s a huge showcase for anyone related to “eyes.”

We, too, are going to launch MME.

Iluvien Has New Data for the FDA

It is anticipated that Alimera will announce successful completion and submission of some long-awaited data to the FDA.

Alimera Sciences has been trying to obtain FDA approval for a sustained intraocular drug delivery system called Iluvien.  This is similar to Ozurdex (Ozurdex is used for the treatment of retinal swelling due to vein occlusions).

Iluvien will release steroids inside the eye for a period of months to control diabetic macular edema.  It is anticipated that this last bit of data will satisfy the FDA and prove that it is indeed safe and effective.

Stay tuned.

Treatment of Macular Degeneration

I don’t think there will be any earth shattering news in this field. VEGF-Trap Eye is probably going to get some press as this is another drug that promises to be quite effective in the treatment of wet macular degeneration.

VEGF-Trap Eye, or afilbercept, is a compound similar to Avastin and Lucentis, but may need to be injected less often than the aforementioned.

Medical Marketing Enterprises

This is our baby.  Amy and I are very excited.  We will be teaching no fewer than 4 courses on medical marketing using websites, blogs, SEO and social media.  There are only about 10 courses offered in total!

I have been invited to address the “Young Ophthalmologists” about marketing.  This group is comprised of young doctors who are still in training (aka residents, fellows) or those who have been in medical practice fewer than five years.

What Does this Mean? I’ll be wearing several hats this time.  I’ll be wandering the floors and attending lectures to learn more about being a retinal specialist.

On the other hand (or under another hat), Amy and I’ll be teaching other doctors how they, too, should create websites such as this to enhance patient education, improve the Internet, and provide marketing solutions.


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FDA Delays Decision on VEGF Trap Eye

VEGF Trap-Eye was not approved by the FDA for the treatment of wet macular degeneration.  The parent company, Regeneron, was hopeful to gain FDA approval last week, but the FDA delayed its decision until November of this year.

VEGF Trap-Eye Treats Wet Macular Degeneration

VEGF Trap-Eye, or aflibercept, is another anti-VEGF drug formulated to treat wet macular degeneration.

Like its competitors, aflibercept is designed to neutralize the effects of the Vascular Endothelial Growth Factor a key component in the pathway of wet macular degeneration.  It, too, will be administered as an injection into the eye as are Lucentis and Avastin.

If you recall, Lucentis is FDA approved for wet macular degeneration.  Avastin is not FDA approved, but is commonly used by retinal specialists, hence, it has become the standard of care.

Fewer Injections into the Eye

Unlike its competitors, aflibercept may be injected less frequently than its competitor, Lucentis.  Instead of monthly injections, VEGF Trap-Eye may be injected every 2 months!

What Does this Mean? There is a potential new drug near FDA approval for the treatment of wet macular degeneration.

Assuming that Eylea (the proposed trade name) is just as effective as Lucentis, there are two particular advantages to the new drug:  cost and frequency of administration.

Eylea will be the third drug to be used for wet ARMD, but only the second that is FDA approved (Lucentis is FDA approved, but Avastin is used “off label”).  It is conceivable that that Eylea will be priced between the two drugs…

Fewer injections means fewer office visits, fewer complications and this means….cost savings (thus an argument to increase the price compared to Lucentis!).

Personally, I think there is room for a drug that doesn’t have to be given monthly.  There are substantial savings to realize;  costs in terms of office visits, costs of injections and the intangible costs…the costs involved to have a family member or friend accompany the patient…



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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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VEGF-Trap Gets Closer to FDA Approval

VEGF Trap for Macular Degeneration and Diabetic Macular Edema

VEGF-Trap (aka aflibercept), another anti-VEGF drug, moves closer to FDA approval as it received “priority review” status.  This status means that the FDA process will be accelerated and the drug can be reviewed in 6 months versus the usual 10 month period.  Alfibercept is another injectable drug that may have an effect on choroidal neovascularization in wet macular degeneration.

In the press release, Regeneron Pharmaceuticals, Inc., cited an incidence of almost 200,000 new cases of wet ARMD in the U.S. alone.  It is the leading cause of new blindness in patients 65 and older.

As with it’s predecessors, Macugen and Lucentis, the company must prove to the FDA that the drug is effective and safe.

Regeneron has also started Phase III clinical trials for VEGF-Trap for the treatment of diabetic macular edema.  There will be two studies, an international study and a North American study.  These trials, too, will be conducted to test the safety and efficacy of alibercept for retinal swelling caused by diabetic retinopathy, or diabetic macular edema.

Diabetic macular edema is the leading cause of decreased vision in patients with diabetes under the age of 50.  Similar studies are underway for Lucentis and Avastin.

What Does This Mean?

On one hand, this is not new news.  Macugen, Lucentis and Avastin have been used for several years for the treatment of wet macular degeneration.  VEGF-trap is the same type of drug as the aforementioned.  VEGF-trap is likely, in my opinion, to gain FDA approval if;  it improves vision better than Lucentis and/or it requires fewer repeat injections to stableize the eye.

On the other hand, using VEGF-Trap for the treatment of diabetic retinopathy will be the first drug to gain FDA approval.  Until now, we (retinal specialists) have been using Avastin and Lucentis “off label” for the treatment of DME.  Approval of VEGF-Trap will validate our suspicions that this is a worthwhile treatment for diabetic retinopathy.


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VEGF Trap-Eye Treats Macular Degeneration

VEGF Trap-Eye (aflibercept) is another treatment for wet macular degeneration.  The sponsoring pharmaceutical companies, Bayer and Regeneron, just reported favorable results in their own Phase III studies.  Basically these studies compared aflibercept against well known Lucentis (ranibizumab).  They report that VEGF Trap is just as good as Lucentis.

Funny Name, But Still an Injection

Despite the misleading name, VEGF Trap-Eye is still an intraocular injection, but instead of monthly dosing (as is often the case for Lucentis and Avastin), the injections may be repeated every 2 months.

Similar to Avastin and Lucentis

Aflibercept, or VEGF Trap-Eye, is a drug that binds to growth factor molecules and prevents them from reaching their targets, or receptors.  In effect, this medication takes any free-floating VEGF molecules and takes them out of circulation.

Though we don’t know for sure, basically this drug, like Avastin, Lucentis and Macugen, will neutralize the effects of VEGF.  As with the others, it will be used to treat wet macular degeneration.

Also Used Against Cancer

There are many similarities between wet macular degeneration and cancer.  Sure enough, as was also the case with Avastin, aflibercept stems from chemotherapy research.  Regeneron, the U.S. based parent, has ongoing trials using VEGF Trap for treatment against metastatic colorectal cancer, certain lung cancers and prostate cancer.

Other Uses in the Eye

Other uses of aflibercept in the eye may include treatment for diabetic macular edema.  Clinical trials for its use in diabetic retinopathy are ongoing.

What Does This Mean? Yet another treatment may be available for wet macular degeneration.  This treatment, however, has the potential to be just as good as Lucentis (and probably Avastin), but, it needs only to be given every 2 months instead of every month.

While the best treatment of Lucentis/Avastin is not known for sure, many doctors including myself, favor injections monthly.  This seems to yield the best results in terms of vision and ultimately reduces the recurrence rate.

VEGF Trap-Eye seems to be equally effective in all these areas, yet differs only by the injection frequency.  Decrease frequency translates into decreased cost, increased compliance (fewer appointments) and improved convenience.

The advantages of sustained release drug delivery systems are highlighted by the advantages of this less frequently used drug.

The company hopes to have some product available as early as end of 2011.

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Emerging Treatments for Diabetic Macular Edema

The standard treatment for diabetic macular edema is still laser photocoagulation (laser treatment).  The treatment has been utilized for about 30 years, yet newer, and better, treatments are on the horizon.  Diabetic macular edema is the biggest, most common, complication of diabetic retinopathy.  Most patients with diabetes will develop some degree of this type of retinal swelling.

Recently there have been several reports of new treatments for diabetic macular edema.  3 studies report the advantages of using anti-VEGF medications and a 4th advocates the use of steroids for treating diabetic retinal swelling.

Lucentis and Macugen To Treat Diabetic Macular Edema

Both Lucentis and Avastin are now acceptable treatments for wet macular degeneration.  Both are anti-VEGF medications.

It seems that anti-VEGF treatmentst may be effective against macular swelling, too.  Separate reports emerged from the 2010 World Ophthalmic Congress that described significantly better results for both Lucentis and Macugen when compared to laser treatment alone.

Both Macugen and Lucentis treatments resulted in better vision when compared to laser treatment alone.  Neither is yet FDA approved for diabetic eye treatment.

VEGF Trap-Eye

This, too, is another anti-VEGF medication.  As with its cousins, Lucentis, Avastin and Macugen, it is delivered as an injection (although the name is quite confusing) into the eye.

Preliminary results in an ongoing study indicate that VEGF Trap-Eye is also an effective treatment for diabetic macular edema.  This study (DA Vinci Study) is ongoing.  Results from its Phase II study were reported.

Ozurdex for Diabetes

Ozurdex is FDA approved for retinal vein occlusions.  It is a sustained release drug delivery system that, when injected into the eye, will release steroids for 4-6 months.

Early results indicate that this treatment, too, may be useful for treatment of diabetic macular edema.

What Does This Mean? Just remember that anti-VEGF medications are likely to be used to treat diabetic macular edema in the near future.  3 reports, all the same class of drugs (i.e. anti-VEGF), getting better results when compared to laser treatment.

Retina doctors have been using anti-VEGF medications and steroids for the past few years to treat patients who are not treatable with laser, or, patients in whom laser hasn’t worked.  These studies are confirming what we are noticing in our offices; anti-VEGF works in diabetes.

The same is true for Ozurdex.  We have long noted improvement in our patients “resistant” to laser treatment.  Intraocular injections of steroids often improves the vision in diabetic patients.  It is not a long shot to believe that a long-acting, sustained drug delivery system would do the same.

All of this is on the horizon.  None of these drugs are FDA approved for diabetic macular edema…yet.

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Retinal Ischemia: Supply vs. Demand

Retinal ischemia causes VEGF to be liberated inside the eye.  In cases of diabetes this can lead to diabetic retinal detachment or neovascular glaucoma.  Treatments included pan-retinal photocoagulation (laser) or anit-VEGF medication such as Lucentis or Avastin.

Ischemia results when oxygen supply does not meet oxygen demand to any tissue.  Other examples  are the heart and legs.  With strenuous activity, O2 demand increases.  If the body can’t compensate, chest pain or leg pain develops.

In cases of proliferative diabetic retinopathy, the retina becomes ischemic due to the loss of the microcirculation of the eye.  The small capillary beds that help feed the retina often get blocked and close off.  Blood flow is reduced, and therefore, so are oxygen levels.

In response to this lack of blood, or oxygen, supply, the ischemic retina produces Vascular Endothelial Growth Factor (VEGF).  VEGF causes abnormal blood vessels to grow on the surface of the retina and other structures inside the eye.  This can lead to blindness by causing a diabetic retinal detachment or glaucoma.

Stop the Ischemia

If we were to stop the ischemia, the VEGF production would cease. If we can change conditions so that supply is equal to demand, the imbalance is gone.

But we don’t know how to improve oxygen supply to the retina.  Presently, laser treatment and anti-VEGF medications are employed.

Laser Treatment Reduces Demand

As we are unable to increase oxygen supply, laser photocoagulation (specifically, pan-retinal photocoagulatoin, aka PRP) is used to decrease demand.  By ablating, a fancy term for killing, retinal tissue, we are in effect, reducing the demand.

If enough laser is performed, the overall O2 requirements will decrease.  Ischemia is stopped and VEGF is no longer produced.

The eye becomes stable.  A diabetic retinal detachment and glaucoma are prevented.

anti-VEGF Medications Block VEGF

Anti-VEGF medications such as Lucentis and Avastin block VEGF from doing its job.  In doing so, neovascularization can not be initiated and diabetic retinal detachment and glaucoma are avoided.

Is the eye stable?

What Does This Mean? Actually I am not sure.  The end result of laser (PRP) and anti-VEGF treatments are the same; preventing retinal detachment and glaucoma.

The use of laser for proliferative diabetic retinopathy is old hat.  It has been saving the sight of diabetics for about 40 years.  It is a good treatment because it fixes the problem.  PRP, when properly performed, stabilizes the eye by eliminating the ischemia.  It secondarily stops VEGF by halting the initial O2 imbalance.

I am not sure; however, if intraocular injections of Lucentis/Avastin actually fix the problem.  There is no mechanism to fix the ischemia.  VEGF is still liberated as the ischemia still exists.  Therefore, careful monitoring and repeated injections are needed.

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New Treatment for Diabetic Eye Disease

A combination of intravitreal injection of Lucentis (ranibizumab) plus laser has just been proven to be a new and more effective treatment for diabetic macular edema.  For the past 25 years, laser photocoagulation (aka laser treatment) has been the mainstay for this most common complication of diabetic retinopathy.

The new treatment involves Lucentis, the anti-VEGF drug also used to treat macular degeneration, in combination with laser photocoagulation.  When used together, a significant improvement is noted.

Traditionally, patients with diabetic macular edema (DME) were treated with laser treatment.  This was pretty successful in keeping patient’s vision stable, yet only a minority of patients did improve.

Over the past two years, there have been many “studies” reporting the use of intravitreal injections of Avastin, Lucentis or steroids as a successful method to treat DME.  This study is noteworthy for the large number of patient that were improved and by the amount of improvement.  Over half the patients experienced vision improvement with the Lucentis plus laser group compared to 28% in the traditional (laser only) treatment.

The significance of the new study was the determination that laser treatment, when given shortly after injection, yielded the best results.

Other combinations were compared; injection with Lucentis and delayed laser as well as triamcinolone (Triesence, a steroid used for injection). Again, the best combination was determined when laser was applied within 3-10 days following the intraocular injection.

During the course of the 24 month study, the  injections were repeated as often as monthly. The visual improvement was sustained over the study period.  3 year results are anticipated.

What Does This Mean? This may quickly become the standard to treat diabetic macular edema. The results, actually of all 3 arms, were improved compared to just laser treatment alone. This may become easily integrated as there really is no new technology introduced to the treatment, but simply combining two regimens already commonly used in the office.

There are small risks with the injections. Intraocular infection is the most feared.

Avastin, an anti-VEGF drug also manufactured by Genetech, will probably be quickly tested, too. It is already used by many of us (retina specialists, that is) for the treatment of wet macular degeneration due to its clinical usefulness and cost (it is much, much cheaper than Lucentis).

Still to be determined is whether this new regimen, Lucentis plus laser, will be endorsed by the insurance companies. Until then, the patient will be responsible for the $2000 cost of the injection. I wouldn’t be surprised if many patients choose Avastin as they have with macular degeneration.

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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.

Virginia Lasik | Office of Anh Nguyen, M.D.
Randall V. Wong, M.D.
Contact: Layla

A: 431 Park Avenue, Suite 103 • Falls Church, Virginia 22046
Ph: 703.534. 4393
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Dressler Ophthalmology Associates, PLC
Randall V. Wong, M.D.
Contact: Ashley (Surgery/Web)
Chrissy Megargee (Web)

A: 3930 Pender Drive, Suite 10 • Fairfax, Virginia 22030
Ph: 703.273.2398
F: 703.273.0239
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