A deeper look at the iDose from Glaukos

David Hutton of Ophthalmology Times talks with Jay Katz, MD, CMO for Glaukos, and Steven R. Sarkisian, MD, about the Glaukos iDose travoprost implant.

Video Transcript

Editor's note - This transcript has been edited for clarity.

David Hutton:

I'm David Hutton of Ophthalmology Times. Joining me today is Jay Katz, CMO for Glaukos, and Dr. Steven R. Sarkisian. To discuss the Glaukos iDose travoprost implant. Approved by the FDA to reduce IOP in patients with ocular hypertension or open-angle glaucoma. Thank you both for joining us. First, tell us about iDose, and how it works.

Jay Katz, MD:

iDose is a combination of a device and drug delivery. It's a titanium device with an anchor. It has a cap, a membrane, and inside is travoprost, a commonly used prostaglandin for lowering intraocular pressure. In a very proprietary formulation inside that canister that can be placed intracamerally inside the eye through a small incision in the cornea temporarily, which is anchored in the trabecular meshwork into the screla wall. And in that position, it can slowly elute through the membrane, the travoprost, which can achieve a therapeutic level in the anterior chamber delivering minute amounts to the target tissue within the eye to lower intraocular pressure effectively for an extended period of time.

This has kind of ushered in an exciting new era of drug delivery that can be sustained with very minute amounts of drug internally, which solves many of the problems that we've really faced over the years with patient non-adherence with topical medications, and also enduring many of the side effects that we're accustomed to with bathing the eye with drugs and preservatives for extended periods of time. So this is a really huge, monumental step forward that we've been waiting for and anticipated for years. And this particular device has been in the works for literally 15 years.

So this is the culmination of a lot of fantastic work by scientists [and] engineers that have really created a a micro device measuring 1.8 millimeters that can effectively lower intraocular pressure in the eye for glaucoma patients. So, this is now maybe a step forward and maybe in a broader scheme of a more proactive treatment paradigm for glaucoma, that will improve the outcome for many of our patients with their disease.

David Hutton:

What's the mechanism of action for this device?

Jay Katz, MD:

Well, all the treatments we have for glaucoma currently are to lower intraocular pressure. Prostaglandins lower intraocular pressure, whether it's used topically or whether it's delivered intracamerally with the iDose TR, and it improves uveoscleral outflow through its mechanism of action of being a Prostaglandin F2α agonist.

David Hutton:

And, Dr. Sarkisian, from your perspective, what does FDA approval of the iDose sustained release travoprost implant mean for ophthalmologists and the patients they treat?

Steven R. Sarkisian, MD:

Well, I'd say I have a list of about 200 patients waiting to have this implanted. And I was extraordinarily blessed to be the highest recruiting investigator in the clinical trial. I was involved in phase 2 and then very involved in phase 3. And so I have a lot of clinical experience with the device. And it's a very intuitive device.

It was so rewarding to see the joy that patients had to be able to be off medication from an eyedrop perspective and have pressures that were controlled pressures. That were preserving their vision. And so what it means is, if we honestly look at patient compliance, I mean, honestly look at it, it's maybe 10%. Perfect. Perfect 10% of the time. And, there's huge data that supports that. We just don't want to accept that. And you know, this is the device that we've been waiting for. This is the you know the treatment, you know the pharmaceutical that we've been waiting for to treat glaucoma, because patients can accept, you know, the advantage. And doctors can accept the fact that it has such lengthy efficacy. And you know that really is the critical thing, is the combination of the safety and the efficacy and the length of time that it works, that it can get people off medications or minimize their medications. And that, to me is so exciting.

And I have the patient feedback of my patients in the study, they're just so pleased, many of them, you know. Mourning the fact that they could only have it in the one eye because of the way that these trials are run. And very excited to get that in the other eye. And many, many patients really been asking - I've been talking about this for so long, it was probably out of all the clinical trials I've done, over 30 trials, this was the easiest for me to recruit for. Because the patients understood it like that. They got it immediately. And they were like, yes, I want that. And so the informed consent process was very easy. Just because it's so intuitive from the patient's perspective to like, why would you do this?

David Hutton:

So you do see this as shifting the paradigm in glaucoma treatment.

Steven R. Sarkisian, MD:

This is going to be the biggest shift in the treatment. Since well. I mean, since trabecular micro bypass I think. It's going to be the biggest shift in the way we do things. You know, I mean, maybe more so because people understand the pharmaceutical treatment of glaucoma. And, you know, so this, it's a different way of doing things.

David Hutton:

And, Jay, how soon could this be prescribed to patients?

Jay Katz, MD:

I think we're looking at the first quarter of next year [2024] that this is going to be kind of available out there in the real community.

David Hutton:

And you're all set to meet the demand that Dr. Sarkisian is alluding to?

Jay Katz, MD:

I sure hope! So I think everybody's excited about, kind of this whole new possibility for treatment. And as Steve said, I think this really does usher in a whole new thought process of how we're going to treat our patients. We've really had difficulty absorbing the fact that a lot of our patients progress, unfortunately, because of non-compliance, non-adherence with topical medical therapy. It's difficult to kind of imagine, for many of us using medications on a chronic basis as eyedrops.

And because of the fact that they're really non-adherent for good reason, there's, you know, it's difficult to getting drops in, difficulty remembering it. There are a lot of facets for why people are not taking their medications, this really kind of really resolves that problem immediately for a lot of our patients. And we shouldn't be surprised that Steve says that his patients are quick to really latch on to the fact that this is really an opportunity for improving their quality of life in many ways. In terms of not having to put drops in on a daily basis. And, and from our perspective, I think it's gonna lead to better outcomes, because they're gonna get the drug 100% of the time. And we're sure to that. This is really, I think it really is going to open up. I think that's just the beginning, not only in terms of drug delivery, being sustained, being able to deliver it in a fashion inside the eye for chronic lengthy period of time, but also is going to change our philosophy and how we're treating patients in terms of really going, are we going to exhaust four or five topical medications? I don't think so.

I think people realize that that really hasn't worked by looking at the numbers of people that are still going blind from glaucoma in our country. The people that are becoming visually impaired, I think, and also the quality of life of our patients. There's one study after another that really shows that we really have to keep that in mind when we're talking about therapies for our patient. They have to enjoy their lives while we're actually treating them for their disease in an effective manner. So, yeah, I'm very optimistic that this really will kind of launch a new way of thinking and we'll have more opportunities for providing treatments that have very good kind of benefit risk profile.

David Hutton:

And is there any information available on the cost of the implant?

Jay Katz, MD:

I think it's it's really, you know, it's really the first step right now. And I think that there's a lot of work being done looking at cost issues and third party payers, and I think that's going to evolve over the next, you know, couple of months. So, that's in the works, and everybody's working their best to make this available to our patients.

David Hutton:

And lastly, are there any other key points regarding this technology that we haven't discussed here today? That would be important to note?

Steven R. Sarkisian, MD:

For sure, I think one of the critical things to also remember is one of the reasons why it was easy for me to recruit for this study was because many of my patients were naive to any treatment. Like they had never been on eyedrops. It wasn't they wanted relief from eyedrop. They had never experienced any treatment, they were totally naive. They never had laser. They had never been on eyedrops. And, you know, I sleep well, knowing that I, by putting in the iDose was able to preserve their vision in the best way possible.