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Eylea Best for Diabetic Macular Edema, Randall Wong, M.D. Retina Speciailst, Northern Virginia, 22030

Eylea Best for Diabetic Macular Edema | Treatment for DME

Eylea Best for Diabetic Macular Edema, Randall Wong, M.D. Retina Speciailst, Northern Virginia, 22030Eylea, Lucentis and Avastin were compared head to head for the treatment of diabetic macular edema.  For certain patients with this common complication of diabetic retinopathy, Eylea was superior.

Common Complication of Diabetic Retinopathy

The common complication of diabetic retinopathy is diabetic macular edema (aka DME, CSME).  The normal blood vessels of the retina leak blood and fluid into the retinal tissue.  When the fluid accumulates in the macula (the functional center of the retina), vision decreases.

Treatment for diabetic macular edema includes laser treatment, intraocular steroid injections, Ozurdex and the use of anti-VEGF drugs.

Anti-VEGF drugs include:  Eylea (aflibercept), Lucentis (ranibizumab) and Avastin (bevacizumab).  Both Eylea and Lucentis are FDA approved for the treatment of DME, whereas all three are used routinely by retina specialists and are considered “standard of care.”

Protocol T | Comparative Study of Anti-VEGF Drugs

A study comparing the 3 drugs has never been completed.  This NIH-funded study, called Protocol T,  is the first to compare these similar treatments for diabetic macular edema.

The study involved 660 patients randomized to receive one of the three drugs.  The study lasted one year with the results published recently in the New England Journal of Medicine.

Results of “Protocol T”

The results indicate that all 3 anti-VEGF medications are effective treatments for DME.  Those patients with moderate or worse vision treated with Eylea, however, improved more than similar patients treated with Lucentis or Avastin.

Moderate vision loss was defined as 20/50 or worse.

To restate the findings;  patients with 20/50 vision or worse had better vision improvement if given Eylea.

For patients with less severe vision loss, the 3 drugs seem to be equally effective.

What Does This Mean?

It is estimated that 75% of the patients receiving treatment for DME have vision better than 20/50.  This comparison indicates the 3 are equally effective.

I personally prefer Avastin over the other two drugs, because, until now, there was no evidence any particular drug was better, but Avastin is significantly cheaper.

We purchase Avastin for about $50 per injection.  Eylea may cost about $1950 and Lucentis $1200.

We finally have evidence giving us clinical evidence as to when to use which drug.

In these days of cost containment, it’s now clear that Avastin, Lucentis or Eylea are equally effective for most patients.  But now, based upon price, Avastin may be the clear “winner” for most patients.

 

 

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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Implantable Telescope is Available!

CentraSight Now Available, CMS to reimburse for implantable telescope to treat macular degeneration

CentraSight, the implantable telescope for macular degeneration, is now available! CMS (Centers for Medicare and Medicaid Services) has approved the telescope for those patients with macular degeneration meeting the eligibility criteria for the surgical procedure.

Medicare/Medicaid will cover the cost of the implant and the surgery in certain patients as October 1, 2011! For now, the procedure has a designation of a transitional pass-through payment, that is, CMS will approve the procedure for 2-3 years until enough payment data can be collected.

The Telescope Improves Vision

To achieve this milestone, Visioncare, the parent company, needed to show that the implantable telescope for macular degeneration met several criteria;

  • FDA Approval
  • CMS deems reasonable and necessary
  • Device offers Substantial Clinical Improvement

FDA Approval: VisionCare received FDA approval for their telescope last August.

Substantial Clinical Improvement may be difficult to attain as the device must surpass some steep challenges.  In order to achieve this status, one of the following situations must be true;

  1. the new device must be better than other available treatments
  2. the device improves the ability to diagnose a condition
  3. the device significantly improves the patient (i.e. clinical outcomes)

Availability of the CentraSight Telescope

For now, according to my contact at VisionCare, CentraSight will be offered at the locations where the original clinical trials were performed.  This has been their plan all along.  With time, as more physicians become trained, the availability will widen.

What Does This Mean? This is the first real step to helping patients with significant visual loss in both eyes.  The surgery to insert the “telesope” is similar to cataract implantation, yet the CentraSight will modify the images so more of the retina surrounding the macula is utilized for vision.

While patients with either form of the disease might be candidates, this is the first FDA sanctioned “therapy” for patients with severe loss of vision from dry ARMD.

This is not a cure or a “fix” for loss of central vision, however, the telescope does improve function for those that have no central vision from the disease and can lead to am improvement in the quality of life.

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Avastin Does Not Cause Infection

One of the most feared complications of eye injections is blindness.  This infection is called endophthalmitis.  Last week the FDA issued an alert the 12 cases of endophthalmitis were caused by the injections.

The cause of the infections is NOT Avastin.  There is nothing wrong with the drug itself.

Avastin Must Be RePackaged

Upon further investigation, a common denominator was a single pharmacy and, possibly, a single lot of tainted syringes.

Avastin is not FDA approved for injection into the eye, but it is standard of care.  Also, Genentech manufactures Avastin and its close cousin, Lucentis.  Lucentis is FDA approved for the treatment of wet macular degeneration.

Thus, in order for physicians like me, to get Avastin, a larger dose of Avastin is ordered.  Once received the “repackaging” of the ARMD drug involves breaking up the larger dose (usually used for chemotherapy) into many more smaller doses for the eye.  The doses are commonly broken up and placed in small syringes ready for injection.

“Repackaging” sounds kind of haphazard, but it’s not.  A licensed pharmacist will distribute the Avastin in smaller allotments under strict sterile conditions.  There are specific protocols for such “repackaging.”

Compounding Pharmacies Routinely Divide Drugs

Apparently, in one particular pharmacy, either the protocol was breached and/or the sterile laboratory conditions were not maintained and they shipped out a few contaminated syringes.  Unfortunately, this caused 12 individuals loss of vision or blindness.

Fortunately, there was a plausible explanation and widespread panic was avoided.

Avastin, itself, is safe.  The mechanisms used to deliver the drug to your doctor’s office are proven safe, too.  Realize that over 2 million injections have been given.

What Does this Mean? Normally, informed consent is obtained prior to the delivery of an injection.  We inform the patient that there is a risk of infection that could lead to blindness.  That risk is estimated to be about 1:1000 to 1:2000 (approximates the risk of cataract surgery).

The source of the infection is thought to be the bacteria that reside on your eyelashes and the surface of the eye, not the actual substance injected nor the container in which it was shipped.

In the end, this was a very rare and unfortunate event for the 12 patients, their families and their doctors.  The culprit; however, was not Avastin.

 

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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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Two Lasers for Diabetic Retinopathy

Laser Treatment for Diabetic Retinopathy

There are two different laser treatments to treat diabetic retinopathy.  One laser treatment is used to treat diabetic macular edema, the most common “complication” of diabetic retinopathy.  The second laser treatment is used to treat proliferative diabetic retinopathy (aka PDR), yet far fewer people develop this potentially blinding stage of the disease.

Same Laser Used for Both Treatments

Macular edema is treated with “focal” laser treatment.  The laser is used to treat/burn/cauterize those areas of blood vessels that are leaking near the macula.  The treatment is focused to treat certain specific areas, hence “focal” laser.

Proliferative diabetic retinopathy (PDR) is treated with “scatter” or “pan-retinal” photocoagulation (PRP).  The peripheral retina is “scattered” with laser burns.

Some Patients Need Both Laser Treatments

The timing of the treatment can be crucial.  Treating the PDR (proliferative diabetic retinopathy) before the macular swelling is controlled, or treated, can lead to progressive loss of vision because the PRP (used to treat PDR) can worse the macular edema.

I prefer treating and controlling the macular swelling first, before treating the neovascular disease (PDR).  Depending upon the situation, however, I don’t always have this luxury as sometimes the PDR is so advanced that we can not wait.

Remember, the neovascularization can cause blindness.

What Does This Mean? In most cases, patients need only one or the other treatment.  Macular edema is treated with focal laser and PDR is treated with PRP.  In the unlikely situation where patients need both…

When possible, I’ll treat the macular edema with focal and wait several weeks, or months, to treat with scatter laser.  I don’t want the macular edema to worsen.

Macular fluid causes decreased vision (patients can tell).  Worsening macular edema means lousy vision….and anxious patients.

Avastin, however, has improved my ability to treat those patients with both macular and proliferative disease.  Avastin (or Lucentis) allows me to treat both the PDR and macular edema…it buys me time!

 

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Do Avastin Injections Hurt?

 

Intraocular injections of Avastin usually do NOT hurt. Once in awhile, I have patients or readers of my blog who complain of severe pain following an intraocular injection.  Why?

It’s Not the Needle That Hurts

I believe the pain is due to the solution used to clean the eye prior to the injection and not the needle itself.

The solution is called “Betadine” and is commonly used to cleanse the eye prior to intraocular injection. Most retina specialists use this a part of their routine.

In a special few cases, these patients are not feeling pain from the needle, they are actually super-sensitive to the iodine prep. This prep is commonly used to clean the eye prior to the actual injection.

Usual Preparation for Injections

My preparation for the “procedure” is probably slightly different than your own doctor’s.

Upon arrival to the office, my patients have already been using antibiotic drops for the past four days. In theory, this limits the bacteria that builds up around the eye and may reduce the chance of infection from the injection.  This has never been proven.

At the office, we dilate the eye and start the numbing procedure. We use a cotton swab dipped in 4% lidocaine (numbing solution) and keep it pressed against the area of injection for about 20-30 minutes. We usually use 2-3 different swabs over the 20 minutes.

How to Keep the Eye Open

Using a spring like device, called a lid speculum, the eyelids are opened. You can not blink.

A drop of Betadine is placed on the eye at the injection site.

While looking “up,” the shot is given using a very short (27 gauge), but very sharp needle. I like to inject at the “6 o’clock” position just beneath the cornea.

After the needle is withdrawn, another drop of iodine solution (Betadine) is placed on the eye.  The eye is then rinsed.

Patients Who Have Pain

Patients who experience pain from the intraocular injection describe pain that last overnight.  Often, they don’t tell me about the horrible experience until the next visit.  This makes me believe that the discomfort is pretty steady for several hours.

To me, this is not injection pain.  Others describe the pain as an electric current.  Almost always the pain takes 12-18 hours to dissipate.  This can not be from a simple needle.  (Ever get an injection in the arm?).

How to Avoid Pain from Intraocular Injections

In patients in whom I suspect a “sensitivity” to Betadine, I’ll omit the iodine-based solution at the time of the next injection.  Almost always, this is the remedy!

Remember, this is my method of treatment and your own doctor may not agree.

What Does This Mean?

It took me several patients to realize that this was happening.  People didn’t complain often, but when they did, the complaints were emphatic.  I believed them.

The best part of this discovery is that…you shouldn’t fear the injections due to pain!  Too many people write in refusing additional injections due to the pain.

If you have experienced a painful intraocular injection, you might want to suggest this to your doctor.  This may be a simple solution to continue treatment to save your vision!


 

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Avastin and Lucentis Are Equally Safe, Too.

Lucentis and Avastin are Equally Safe

 

The results of the CATT trial demonstrated that Avastin and Lucentis are equally effective for the treatment of wet macular degeneration.  A small issue, since the release of that data, appears to be whether Avastin has more side effects than Lucentis.

Avastin is as safe (or as dangerous) as Lucentis.

The CATT trial results were data from the first year of a 2 year study.  The results from the 1 year data of the CATT study did not directly address safety concerns between the two drugs.

Safety data, from the second year of the study, were released at the Association for Research in Vision and Ophthalmology (ARVO) this past weekend in Sarasota, FL.

The data indicates that the safety profile is equivalent in that the rates of death (<3%), stroke (about 2%) and all similar vascular events (about 1%) were statistically the same.
(Off the top of my head, I am not aware of the normal chance of these events occurring in a similar study group.  This should be revealed at the conclusion of the study.)

What Does This Mean? As I stated last week, this further validates the use of Avastin for the treatment of wet macular degeneration.  Not only is it cheaper and just as effective…but it appears that it is just as safe.

The systemic complications of death, stroke and “other” events, in my opinion, has been very difficult to sort out.  These numbers do not necessarily mean an increased risk greater than normal (with or without the shots).

Remember that the chance of these events occurring increases as we age, that is, the study simply reports the rate of these occurring, but does not compare to the normal “chance” or incidence of one of the outcomes.

Eye disease, such as macular degeneration, increases as we age, too.

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offices

Currently, I see patients with retinal diseases; macular degeneration, retinal detachment, macular holes, macular pucker within several different practices.....it'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
F:703.992.8158
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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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