Why should you get started with iDose TR (travoprost intracameral implant) 75 mcg?

Ophthalmology 360 presents “Why should you get started with iDose TR (travoprost intracameral implant) 75 mcg?” featuring Drs. Deborah Ristvedt, Morgan Micheletti, and Savak Teymoorian.

Savak Teymoorian, MD:

Hello, everybody. This is Dr. Savak Teymoorian. I’m a interventional glaucoma and cataract specialist in Orange County, California. My private practice is Harvard Eye Associates. I have two wonderful people we’re going to be talking to today, and I will let them introduce themselves.

Deborah Ristvedt, DO:

Hey, everybody. I’m Deb Ristvedt from Vance Thompson Vision in Alexandria, Minnesota. And my specialties are cataract, glaucoma, and oculoplastics.

J. Morgan Micheletti, MD:

Howdy, everyone. Morgan Micheletti here from Berkeley Eye Center in Houston, Texas, where I’m a cataract refractive and interventional glaucoma specialist.

Savak Teymoorian, MD:

I love it. Great to have both of you guys here. I appreciate the time you guys are spending with us. I’m sure you guys will give us some really wonderful tidbits here to share. And gosh, it’s always great to have all of us together, because we get so excited to talk about glaucoma, but specifically where glaucoma is going and interventional glaucoma. We’ll be talking about a couple of things today, but I’d love to get just your preliminary one- or two-minute elevator speech on what do you guys actually think interventional glaucoma is and what are we trying to do with our patients?

J. Morgan Micheletti, MD:

So, the way I like to, whether I’m talking to another surgeon or a patient about it, I really bring up the topic is, we’ve kind of always played from behind in terms of glaucoma. We’re always waiting for patients to progress before we escalate treatment or therapy because a lot of our therapies and treatments could be very invasive, or would have a ton of potential side effects, like multiple drops. And because of what first started as MIGS and now the procedural pharmaceuticals that are available, we’ve really been able to be more proactive about preventing that progression in the first place. So, I tell my patients that, “Hey, this is something that we have now, interventional glaucoma, where we can get out in front of the disease and treat it before we see these progressive changes over time.”

Deborah Ristvedt, DO:

Yeah. That’s awesome, Morgan. When I finished residency, it was right when the iStent was introduced. And it’s so funny, because I look back to 2011 and I’ve kind of been practicing interventional glaucoma all along without realizing it because I believed in it. So, really, interventional glaucoma is a mindset. It’s saying, “Wow, can I do something earlier in the disease course? And how do I keep my patients, who are really suffering from side effects from glaucoma therapies, off of drops?” And it’s just amazing how the glaucoma space has evolved over the last decade.

Savak Teymoorian, MD:

That’s great. And I love the energy here and the explanation there. So, buzzword here, procedural pharmacological agent, what exactly is that? How do we classify that? What is available? And how do you guys actually use that in your practice?

Deborah Ristvedt, DO:

There have been so many developments in the glaucoma space, as we mentioned, from SLT as being first-line therapy to really looking at the quality of life for our patients. And when I think about the opportunity to really keep patients off of drops that, again, cause side effects and are costly over time, we now have options to use medications that we know work, but in a different manner. That’s where this pharmacological procedure comes in play. To think about how Glaukos has evolved this space, it took them 15 years to develop this pharmacologic agent, 15 years. And it is 75 micrograms with like 200 times less of a dose than one drop. I mean, how incredible is that? I’m just so fascinated by how they even got there.

What do you think, Morgan?

J. Morgan Micheletti, MD:

Yeah. I like to think of this as we’re kind of catching up to what the retina specialists have had for a long time, and that is these procedural pharmaceuticals with Avastin and some other anti-VEGF agents. Now, all of a sudden, we have something that we can actually give a patient that is hands-off. They don’t have to worry about using the drop because we know patients struggle with compliance, right? It’s something like 80% of patients have stopped using a medication that was started in terms of a topical medication at six months.

So, having something that we know and have that confidence to be able to implant into the eye, such as Durysta or iDose TR, both of which are great and they work inside the eye, but they have different capabilities in terms of how long they last. And keeping them off the drops or potentially reducing the number of drops is really a secondary benefit. I mean, the primary benefit is that we know we’re going to deliver drug to where it needs to be in a consistent manner without the patient having to remember, or, for us, as physicians, to be reliant on their compliance.

Savak Teymoorian, MD:

Yeah. I think you guys are hitting it right on the head, where glaucoma treatment with the reduction of pressure, obviously, that’s the goal, but you’re talking about these barriers of topical agents and we’re trying to bypass them. That’s where that idea of procedural pharmacological agents comes into play is, how can we be doing it better? So, really the question I want to pose to you is, if I’m a new ophthalmologist provider, I’m thinking about integrating interventional glaucoma in this whole space of procedural pharmacological agents, where do you guys use this in the treatment paradigm? I know there’s no perfect way or algorithm that we follow, but how do you guys see this fitting in and how do you think about it with your patients?

Deborah Ristvedt, DO:

I always like to tell our patients that glaucoma is not curable, but it’s treatable. I really like to take a staged approach with our patients, meaning I’ll talk to them about the disease state and talk to them about how it’s such a beautiful space to be living in right now, because we do have so many options. So, we have a couple different goals. We want to manage their pressure, which we know slows down the progression of vision loss, and we want to be able to make sure that their pressure is stable over time. That’s where we haven’t really had anything to be confident with in the past as far as medications go to say, “Yes, we’re delivering 24/7 IOP control.” [Results may vary.] So, I really take a staged approach with our patients and say, “Hey, number one, we want to do things earlier on before the disease progresses. We want to do things in a safe way and we want to do things in an effective manner.” That’s really how my algorithm has changed over time is thinking about this disease state as a long-term process.

J. Morgan Micheletti, MD:

Yeah. I think that’s great, and I agree with all of that. I think what’s been the big frame shift in my own thinking from residency, which is getting further and further away, but…

Deborah Ristvedt, DO:

Oh, you’re young.

J. Morgan Micheletti, MD:

… but in residency it was, “All right. Patient’s on one drops, let’s go to two drops. They’re on two drops, let’s go to three drops. They’re on three drops, let’s go to max topical or maximum tolerated therapy. Now, let’s start an oral.” And we’ve had this shift once we started getting MIGS in general and physicians getting comfortable in the angle delivering treatment that’s going to work around the clock as well as the timing of the LiGHT trial and the improvements we’ve seen in SLT. All of a sudden we started seeing this shift. And now that we have so many options when it comes to MIGS, especially a standalone option, something like the iStent infinite, we now have a reason to potentially bring a patient back to the OR alone without pairing it with cataract surgery to help lower the pressure.

So, I think this beautiful shift over time from the original iStent way back when to the furtherance of other angle procedures to now pharmaceutical procedures, so the iDose TR I think is really important to qualify is not a MIGS procedure, because it’s not. All of our MIGS procedures target trabecular meshwork and help to either bypass it or augment it, whereas this is actually delivering a medication.

So, if I see a patient who has new glaucoma, I’m going to get them scheduled for SLT, but I may start them on a drop temporarily while we get them scheduled and let the SLT take effect. And if I need to escalate beyond that, then maybe we keep them on the drop a little longer, and then we’re escalating to the next thing. If they’re phakic, it may be cataract surgery. If they’re not, then it may be a standalone MIGS procedure after SLT, or now we have these procedural pharmaceuticals such as Durysta and iDose TR. And really, it’s a discussion with patients. I find it a lot easier to bring a patient back to the OR, at least now early in these discussions, who have already been.

That means is they’re comfortable potentially going back. So, with all of that, I think, looking back, it’s really just the fact that, for me, drops has become a bridge.

Savak Teymoorian, MD:

Yeah. I think you guys are all bringing up a good point. One thing I want to clarify is some procedural pharmacological agents like iDose TR, they’re not MIGS procedures, which we really do want to differentiate. So, let’s talk a little bit about what are your indications? Can we do this as a standalone? Do I have to do this with cataract surgery? What does that mean for billing? Can we talk just a little bit about that and the indication itself?

Deborah Ristvedt, DO:

iDose TR was really designed in patients who have primary open-angle glaucoma and ocular hypertension. So, that really includes a large subset of our patients. So, when you look at who is a candidate, it’s really a multifactorial question. I mean, where are they at in their disease process? How many drops are they on? What are their goals? Is it to become less drop-dependent because they have more side effects, or because the drops themselves are becoming too costly or too difficult to put in? Is it because their disease state is progressing and we worry about compliance? But right now, bypass that and do something along the pharmaceutical line. So, again, that’s where that staged approach comes in. And as iDose TR has come to light, we’ve just been waiting and finally in July we got a J code.

So, just like our anti-VEGFs, now we have a J code as well as a procedural code. So, that has been designated now. So, when I look at my patients, I do right now look at their insurance plans just because we’re getting going with this, we’re making sure that as we submit these claims that we’re getting paid. I’ve really worked with our billing team to make sure that, again, the insurance companies are aware of this procedure and then we wait for payment. And we’re starting to see that now. So, it’s really exciting to see how just in the last short few months, things are evolving. So, you look at the broad spectrum of patients that could benefit from direct pharmaceutical release in the eye versus topically, that’s huge when we know about compliance issues and beyond.

J. Morgan Micheletti, MD:

What’s great about the iDose TR is that it has a pretty broad indication, so open-angle glaucoma and even ocular hypertension, which I think is a great thing to include. And as Deb was saying, we have the J code, which is J7355, I believe, and then a 0660T. And these codes, really what they help do is they help just establish a method for making sure that physicians are appropriately reimbursed for the work they’re doing.

The way I like to think about the iDose TR and when and where I’m using it is, am I already taking the patient to surgery for something else? If I have a patient who has glaucoma and I’m taking them to cataract surgery, it’s absolutely a consideration if I can implant an iDose TR, just like it would be a consideration for any glaucoma patient that I would take to the OR for cataract surgery to consider MIGS. And for me, if I’m taking them back to the OR, I have to ask myself, “Why not? Why not do an iDose TR in this case if I know it’s going to benefit the patient? And it works in a separate way.” It’s not an angle or trabecular bypass procedure. It’s an implantable pharmaceutical that is going to slowly release drug and work in a different way, all just helping the patient.

Savak Teymoorian, MD:

And I think you guys are bringing up good points. But now you’re starting to talk about J codes and medications. Our retina colleagues are very comfortable in that space. We’re not necessarily quite as versed, so there definitely is a learning curve to getting past that. But these are all things that, again, as long as we’re taking care of our patients, new things come up and we either see these challenges as stepping stones of getting better or seeing them as obstacles. And you guys have definitely helped out in sharing your knowledge in terms of how we can incorporate iDose TR here into the practice. So, I will leave it with this, if there’s one piece of advice you’d like to give to someone who’s thinking about starting with iDose TR, a piece of advice you wish you knew that maybe you’d done differently, or something you did that turned out being really great, what would you want to share with your fellow colleagues?

Deborah Ristvedt, DO:

Man, I think it’s just get comfortable in the angle. We’re so fortunate to have so many devices that really optimize the outflow pathway. And when I think about having another tool in my toolkit, not only to get that 24/7 IOP control, but to optimize stability in the intraocular pressure, it’s a win-win situation. So, I would say my biggest advice would be to think of this as a long-term game.

J. Morgan Micheletti, MD:

Interventional glaucoma is here and it’s not going anywhere. So, if you’re not already on board, it’s time to hop on board because it’s the way of the future. It really is. It’s the way of the future. We have the tools now that are necessary to help prevent progression earlier in disease. And if you’re comfortable at all in the angle, and even if you aren’t, there’s plenty of tools now from model eyes and different labs you can do to get more comfortable in the angle. That’s really the gateway. If you can visualize the angle, there are so many different things you can do, not only in the MIGS space, but like we’re talking about with the iDose TR.

Savak Teymoorian, MD:

I love the case examples you guys gave. It truly is an exciting time. Some of this stuff we know, some of this stuff we don’t even know what we’re getting into, but it’s really allowing us to individualize patient care, especially with our glaucoma patients. So, this is all great stuff moving forward. I would like to personally thank you, guys, Deb, Morgan, really appreciate your time. Thank you, guys, for spending time with us.

If you find this information useful, please feel free to let us know and hopefully we can join you guys again soon. You guys have a wonderful evening. Thank you so much.

J. Morgan Micheletti, MD:

Thank you.

Deborah Ristvedt, DO:

Thank you.

IMPORTANT SAFETY INFORMATION for iDose^® TR (travoprost intracameral implant) 75 mcg

Dosage and Administration

For ophthalmic intracameral administration. The intracameral administration should be carried out under standard aseptic conditions.

Contraindications

iDose TR is contraindicated in patients with active or suspected ocular or periocular infections, patients with corneal endothelial cell dystrophy (e.g., Fuch’s Dystrophy, corneal guttatae), patients with prior corneal transplantation, or endothelial cell transplants (e.g., Descemet’s Stripping Automated Endothelial Keratoplasty [DSAEK]), patients with hypersensitivity to travoprost or to any other components of the product.

Warnings and Precautions

iDose TR should be used with caution in patients with narrow angles or other angle abnormalities. Monitor patients routinely to confirm the location of the iDose TR at the site of administration. Increased pigmentation of the iris can occur. Iris pigmentation is likely to be permanent.

Adverse Reactions

In controlled studies, the most common ocular adverse reactions reported in 2% to 6% of patients were increases in intraocular pressure, iritis, dry eye, visual field defects, eye pain, ocular hyperaemia, and reduced visual acuity.

INDICATIONS AND USAGE

iDose TR (travoprost intracameral implant) is indicated for the reduction of intraocular pressure (IOP) in patients with open angle glaucoma (OAG) or ocular hypertension (OHT).

Please see full Prescribing Information.

You are encouraged to report all side effects to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also call Glaukos at 1-888-404-1644.

Risk Information

The most common side effect of iDose TR was increased eye pressure. Other common side effects were inflammation of the iris, dry eye, a loss of part of the usual field of vision, eye pain, eye redness, and reduced clearness of vision.

INDICATION FOR USE. The iStent infinite^® Trabecular Micro-Bypass System Model iS3 is an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is indicated for use in adult patients with primary open-angle glaucoma in whom previous medical and surgical treatment has failed. CONTRAINDICATIONS. The iStent infinite is contraindicated in eyes with angle-closure glaucoma where the angle has not been surgically opened, acute traumatic, malignant, active uveitic, or active neovascular glaucoma, discernible congenital anomalies of the anterior chamber (AC) angle, retrobulbar tumor, thyroid eye disease, or Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. WARNINGS. Gonioscopy should be performed prior to surgery to exclude congenital anomalies of the angle, PAS, rubeosis, or conditions that would prohibit adequate visualization that could lead to improper placement of the stent and pose a hazard. MRI INFORMATION. The iStent infinite is MR-Conditional, i.e., the device is safe for use in a specified MR environment under specified conditions; please see Directions for Use (DFU) label for details. PRECAUTIONS. The surgeon should monitor the patient postoperatively for proper maintenance of IOP. Three out of 61 participants (4.9%) in the pivotal clinical trial were phakic. Therefore, there is insufficient evidence to determine whether the clinical performance of the device may be different in those who are phakic versus in those who are pseudophakic. ADVERSE EVENTS. The most common postoperative adverse events reported in the iStent infinite pivotal trial included IOP increase ≥ 10 mmHg vs. baseline IOP (8.2%), loss of BSCVA ≥ 2 lines (11.5%), ocular surface disease (11.5%), perioperative inflammation (6.6%) and visual field loss ≥ 2.5 dB (6.6%). CAUTION: Federal law restricts this device to sale by, or on the order of, a physician. Please see DFU for a complete list of contraindications, warnings, precautions, and adverse events.

PM-US-2317

The doctors were compensated by Glaukos for their time.