Tag: Clinical trial

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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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Diabetic retinopathy Macular Degeneration Treatments

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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Diabetic retinopathy Treatments

FDA Denies Iluvien

Iluvien Denied by FDA

The Food and Drug administration fails to approve Iluvien for the treatment of diabetic retinopathy and cites the need for more safety information in addition to concerns about the safety of the manufacturing process of Iluvien.   Alimera Sciences had hoped to gain approval by the end of December 2010, instead, it was told by the FDA that more information was needed.

Safety and Efficacy of Iluvien

Data from almost 1000 patients were included in the FDA submission.  If you remember, Alimera Sciences received a “Priority Review” from the FDA when the application was filed last summer.  A “Priority Review” accelerates this last leg of the FDA approval process.

Instead, the FDA is asking for additional safety/efficacy information covering 36 months after treatment instead of the 24 months provided.

Is Manufacturing Safe?

There were also concerns regarding the manufacturing, packaging and sterilization of Iluvien, though no specifics were noted.

What Does this Mean?

We’ve now heard about Iluvien for diabetic macular edema for over a year.  At the outset, the news has been promising and the technology exciting.  For patients with diabetic macular edema, this drug promises options to the old standby …laser treatment.

Iluvien may be the second drug approved that is based on technology to offer sustained drug delivery into the eye.  Ozurdex, a similar product, has been in use since the summer of 2009 and is used for retinal vein occlusions.

While promising, the FDA plods slowly, yet thoroughly.  The request for additional data indicates that this product is probably effective for treating macular edema, yet recommendations need to be made regarding is use.  Hence, the need for additional dtate.

Had the product been rejected, or requests for additional clinical trials, this would have been a clearer signal of failure.

In the end, though disappointing, the company hopes to have a marketable product by the end of 2011.

Hang in there.

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Macular Degeneration Uncategorized

Update on Implantable CentraSight Telescope

VisionCare’s implantable telescope for patients with advanced macular degeneration was FDA approved in August.  Since then, little information has been available, but I received an update from the company last week.

Telescope is Not Being Shipped

Though FDA approval has been received, VisionCare, the parent company, has not started shipping this implantable device.  The company is quite small and is gearing up for market release.  Reading between the lines, this may occur in the next 6 months.

Medicare Reimbursement

In simplest terms, Medicare has yet to approve this device for insurance coverage, that is, they haven’t agreed to pay for it yet.  The parent company must submit an application based upon the FDA approval and the fact that this is a brand new type of medical device.

Obviously, VisionCare isn’t going to ship the Centrasight telescope if it isn’t going to be covered by insurance.

Training Centers for Eye Doctors

If you read my last article regarding the CentraSight, the implantation of the telescope involves a team approach and, thus, training for all the eye professionals involved.  Training will be required for the surgeons, eye doctors, nurses, technicians, etc.

The company is hopeful to start the initial “launch” at the centers involved in the clinical trials.  Additional sites and doctors will be added as time goes on.  My own practice is hopeful to be one of the first to train.

Information for Patients

Additional information has been provided on the CentraSite web page.

What Does This Mean?  At the very least, the telescope will have limited availability for the first half of the year.  Without Medicare approval, the device simply won’t be marketed.  The development of other centers for the device to be implanted will depend upon the initial revenues and popularity of the device.  This is not unlike cell phone coverage. 

The CentraSight telescope is also a good example of how the FDA and Medicare together to bring devices to market.  FDA approval doesn’t mean Medicare’s endorsement as the two operate independently.

Overall, there are many variables to watch;  the speed or rate in which new centers are developed and new doctors trained and the fiscal issue of insurance payment.   Be patient.

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