Tag: Bevacizumab

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Diabetic retinopathy Treatments

Eylea Best for Diabetic Macular Edema | Treatment for DME

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

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.

 

 

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Diabetic retinopathy Treatments

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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How I Practice My Opinion

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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Macular Degeneration Treatments

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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