August 2018

COVER FEATURE

Glaucoma's armamentarium
Zooming in on standalone MIGS


by Liz Hillman EyeWorld Senior Staff Writer


The iTrack illuminated catheter can be used to perform ABiC or GATT.
Source: Ellex

Trabectome handpiece unroofing Schlemm’s canal in trabecular meshwork removal
Source: NeoMedix


XEN is indicated for use as a standalone procedure or with concomitant cataract surgery.
Source: Joseph Panarelli, MD

EWrePlay.org

Standalone MIGS
Steven Sarkisian, MD, discusses standalone MIGS procedures.

 

On-label options that stand alone and making the decision to go off-label in some cases

Savak Teymoorian, MD, Harvard Eye Associates, Laguna Hills, California, has a significant number of glaucoma patients who come into his practice in need of further IOP reduction to protect their optic nerve. While they might be good candidates for a microinvasive glaucoma surgery (MIGS), a sticking point for many of these patients can be that they’re already pseudophakic. They don’t need concomitant cataract surgery that some of the MIGS options are approved in conjunction with under the labeling by the U.S. Food and Drug Administration (FDA).
iStent (Glaukos, San Clemente, California), the iStent inject (Glaukos), and the CyPass Micro-Stent (Alcon, Fort Worth, Texas) are approved for patients with mild to moderate primary open angle glaucoma as a combination procedure with cataract surgery, but the call for these—and other options—in the standalone MIGS market is growing.
“There’s definitely a market and a need for it,” Dr. Teymoorian said. “For instance, we have a lot of patients who are referred. They’re already pseudophakic, and they need some kind of advancement in their therapy, but I don’t want to resort to a gold standard trabeculectomy or tube shunt surgery because although they’re good at reducing pressure, there’s a lot of risk involved.”
The only standalone MIGS stenting device approved without the concomitant cataract surgery is the XEN Gel Stent (Allergan, Dublin, Ireland), which is for more advanced stages of disease, but others are in the works.
From a safety perspective, Dr. Teymoorian said he’s not concerned about performing standalone MIGS off-label, but it often comes down to if the patient is willing to pay. There are procedures that could be considered MIGS, such as goniotomy and trabeculotomy, which don’t have labeling restrictions limiting them to combination with cataract surgery. The catch here, Dr. Teymoorian said, is they do come with a little more risk compared to stenting procedures.
“Although there’s a little more risk in those procedures compared to traditional trabecular bypass, like an iStent, these would be covered as a standalone,” he said, explaining that he would use them if the patient didn’t want the out-of-pocket expense with an off-label stenting procedure.
Richard Lewis, MD, Sacramento Eye Consultants, Sacramento, California, performs MIGS procedures that don’t have labeling restrictions as standalone procedures, but he’s also implanting MIGS devices (iStent and CyPass) off-label when the situation calls for it.
“The bottom line is I’m the one who is responsible for the safety of these surgeries,” he said. “Patients have read a lot about this and they come in demanding a safer and a better surgery. One of the problems with trabeculectomy is the long-term risk of infection and endophthalmitis. Patients don’t want that; they’re concerned about long-term risks and they may be willing to pay cash or go off-label and we hope that [insurance will] approve it. Sometimes they do, sometimes they don’t. The driver has to be what’s best and safest for the patient.”
Sometimes Dr. Lewis initiates the conversation about the potential for an off-label MIGS procedure with patients, while other times, the patients are broaching the topic with him.
“The patients are much more informed than they used to be, and they know this is a lifelong disease,” he said. “They’re not just thinking acutely how to get the pressure down, they’re thinking how do you keep them seeing for the rest of their life. That’s where it gets so conflicted here.”
Constance Okeke, MD, Virginia Eye Consultants, Norfolk, Virginia, said she takes a conservative, stepwise approach in her glaucoma management.
“Would I go from a standalone medication straight to surgery and bypass laser?” Dr. Okeke asked. “No. … But when the laser treatment hasn’t worked or it’s not an option, the MIGS procedures can play a role for these patients.”
As standalone MIGS procedures, Dr. Okeke said she currently uses or has used the Trabectome (NeoMedix, Tustin, California), ab interno canaloplasty (ABiC) with the iTrack (Ellex, Adelaide, Australia), the Kahook Dual Blade (New World Medical, Rancho Cucamonga, California), gonioscopy-assisted transluminal trabeculotomy (GATT), and the Visco360 and Trab360 (Sight Sciences, Menlo Park, California). She has implanted CyPass as a standalone procedure in pseudophakic patients, off-label, with good results, but it’s not something she offers at this time. Dr. Okeke said she is slated to add XEN as a standalone procedure in her practice later this year.
For Dr. Okeke, patients who might benefit from a standalone MIGS procedure are those who are on drops, have had a laser treatment with no or only little response, and they need more therapy to reduce pressure. Maybe they’re on the maximum medical therapy they can tolerate, Dr. Okeke said.
“Now you have surgery, where this patient is pseudophakic or phakic, but I don’t want to take out the cataract because it’s not part of the issue because [the lens] is clear and it’s not stretching the angle in anyway, so I don’t want to do a combined procedure. Here I am needing to get their pressure down, and if my options are just the traditional glaucoma surgeries—if this is a mild to moderate glaucoma—I’d like to try to avoid doing a trabeculectomy or avoid doing a tube shunt,” Dr. Okeke said, adding that she thinks those with more advanced glaucoma can be candidates for MIGS as well, even while they might only be indicated for mild to moderate disease.
In terms of a discussion with the patient when the MIGS procedure is considered off-label, Dr. Okeke said she emphasizes the patient’s need for further pressure reduction and the efficacy of these procedures that are FDA approved with cataract surgery. She tells patients her experience with these devices without cataract surgery is good and that she thinks it could offer the patient the pressure reduction they need, adding, however, that it would likely be an out-of-pocket expense.
“For many people, the expense can be the limiting factor. If they don’t have the money, they can’t do the procedure, but some of them are willing to pay for the option of having something that has the potential to work in a less invasive way,” she said.
Dr. Lewis said prior to ICD-10, glaucoma surgeons were able to perform surgery on patients with glaucoma independent of what type they had. ICD-10 is more specific in terms of stage and type of glaucoma.
“Ever since then, the insurance companies have become very strict about staying on-label in terms of allowing them to do surgery. For a lot of things in the MIGS world, it’s for mild to moderate glaucoma but that doesn’t always fit what is best and safest for the patient, and that’s where it becomes frustrating because the usual advantage of MIGS is safety,” he said. “We’re locked into doing this in only mild to moderate when the more advanced have just as many safety needs as the mild to moderate, and that becomes a problem because they’re denying care. Either we have to come to some agreement with the insurance companies or we’re going to have to broadly label by doing more studies.”
All three doctors said they think the labeling of MIGS procedures that require them to be done in conjunction with cataract surgery needs to change. In some cases, studies that could potentially change or expand this labeling are in the works. There is a clinical trial evaluating the 5-year results of standalone CyPass implantation. Dr. Okeke noted the iStent inject has been in studies as a standalone procedure as well, with results showing safety and IOP-lowering ability.
Research to expand labeling can be expensive though, Dr. Lewis noted.
Independent of the labeling of these devices and procedures is the challenge of understanding what’s the best choice for the patient, Dr. Lewis said.
“Forget advanced, mild, moderate. Is pseudoexfoliation best suited for a canal-based procedure or is it not? If we as clinicians could sort through this and begin to give advice to our colleagues, that would be a huge benefit. It comes up all the time in meetings, the problem is getting data,” he said, explaining that he thinks the American Academy of Ophthalmology’s IRIS Registry could contribute on that front in terms of looking at how these patients fare with different procedures and what factors led to their success or failure.
There are also questions of timing and combination with newer procedures.
“How long we keep people on medications is an issue. I think the newer medications [and] what role they’re going to be playing with regard to the meshwork is an interesting question,” Dr. Lewis said. “Can we benefit from combining the newer medications and MIGS? There are a lot of questions, but we have to make decisions each day we see patients, we can’t wait for these studies to come out, so we need to collect more information and begin to get a better handle on the data we’ve got so far.”
Dr. Teymoorian also thinks that more needs to happen from an education standpoint both for patients and physicians.
“Patients need to be more educated in that there are surgical options in glaucoma that are relatively safe to do,” he said. “On the physician side, as we’re becoming more and more aware of MIGS, there are some people who are further along, but there are still a lot of doctors out there, it’s not first in mind, they don’t even look for how this can be used in their cataract patient or standalone patient. So there is still some physician education that needs to be done.”
The paradigm is shifting from glaucoma treatment being reactive to proactive, Dr. Teymoorian continued. “We used to allow the optic nerve to get worse … then we would react to it and we would hope by giving some kind of medication that would be enough,” Dr. Teymoorian said, adding that this is because the only alternatives at that time were more medication or trabeculectomies and tube shunts. “Now, we’re trying to play to win, we’re trying to be proactive, and the reason that we can do that is we have good players in the game and we have other options.”

Editors’ note: Dr. Lewis has financial interests with Alcon, Allergan, Glaukos, New World Medical, Sight Sciences, Ivantis (Irvine, California), and Aerie Pharmaceuticals (Durham, North Carolina). Dr. Okeke has financial interests with Alcon, Allergan, NeoMedix, Glaukos, and Ellex. Dr. Teymoorian has financial interests with Glaukos, Alcon, and New World Medical.

Contact information

Lewis
: rlewiseyemd@yahoo.com
Okeke: iglaucoma@gmail.com
Teymoorian: steymoorian@harvardeye.com

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