FDA approves XDEMVY, the first and only treatment for Demodex blepharitis

XDEMVY, the first and only treatment option for Demodex blepharitis, was approved by the FDA. Dr Selina McGee, a key member in the clinical trials behind the treatment, met with Optometry Times to take a deeper dive into XDEMVY and Demodex blepharitis.

Video transcript

Marlisa Miller:
Hello, everyone. I'm Marlisa Miller with Optometry Times, and I'm sitting down with Dr. Selina McGee to talk about the recent FDA approval of XDEMVY, previously known as TP-03 from Tarsus Pharmaceuticals, used to treat Demodex blepharitis. Welcome Dr. McGee, it's great to have you here.

Selina McGee, OD, FAAO, Dipl ABO:
Thank you.

Miller:
Great to have you. First, can you tell me a little bit about XDEMVY?

McGee:
Definitely. So XDEMVY was approved just yesterday, and very exciting because it is on label for the indication of Demodex blepharitis, which is very common in our clinics. It's something that is truly a large unmet need, because historically, we haven't had a prescription therapeutic on-label to treat Demodex blepharitis. And so to gain this approval, and to actually gain it early is really exciting.

Miller:
Great. Can you tell me a little bit more about the Saturn-1 and Saturn-2 clinical trials?

McGee:
Sure. So when you look at the clinical data, and they had some really interesting clinical end points that we aren't historically looking at, from, you know, even a dry eye perspective or something different. So this is again for Demodex blepharitis. So they looked at at 2 things. So collarettes, and how many were on lids, and they looked at the eradication of collarettes as well as eradication of mites. Because what we now know is collarettes are pathognomonic for Demodex blepharitis.

So what I love about that is it's really easy to identify in the clinic. And when I see clinical studies that translate easily into clinic, that makes it that much easier for us to adopt and identify the patients. So now that we have a prescription medication, like XDEMVY to treat our patients that's very impactful.

So that's the first piece, and the second piece was actually looking at erythema cure, and looking at the eyelid redness. And that's different than what we normally look at, but it very much is something we should be looking at because our patients are suffering with eyelid redness and red eyes. And it's interesting because clinically, patients will say my eyes are red, but they don't always understand that it's actually what they see in the mirror is it's the their lid that's red. And then when we take a little deeper look behind the microscope, and we see that the patient has collarettes and they have Demodex blepharitis, then that is one of the issues that can happen with Demodex and having that redness. And so that's how it can come through clinically. So when you look at both of those clinical end points, very important looking at Saturn-1 and Saturn-2 that we see erythema improve, as well as overall redness, which is what the label says. And improvement on lids for Demodex blepharitis.

So it's a really clear label. And it's a broad label, which is nice because we see collarettes, we know the patient has Demodex blepharitis, now we have a prescription for Demodex blepharitis, and we can move forward there. So the clinical data is really clear for us.

Miller:
Great. That sounds amazing. What can optometrists do to identify patients who are at risk for Demodex blepharitis? What kind of symptoms should they be looking for?

McGee:
Sure. So symptoms and signs. So one thing that patients will often report, or sometimes we just have to ask really good questions, so itching is really common and identifying where the patient itches. So I will often ask patients to show me where it itches. Typically, if they say, you know, it's on the inside corners like this, that's more indicative of allergic conjunctivitis, and they'll have more signs that go along with that. But when the patient says it just is really itchy like this, that's very indicative of Demodex blepharitis.

So that's one symptom, but patients will often have redness that they'll complain about. They will sometimes have history of recurrent hordeola, recurrent chalazia. If they have recurrent issues like that, that's almost 100% of the time Demodex blepharitis as the culprit.

So those are some of the common things. One thing that we all see as optometrists and eye care providers is patients that wear contact lenses. And we know that contact lens discomfort can come also from Demodex blepharitis. And so for those patients that want to wear their contact lenses comfortably for longer, this is an easy way to identify and now be able to treat.

So for ODs out there, that's the symptoms. And then when we look at signs, it's really simple. We just have our patients look down, and we do this on every single patient because it is so common. I mean around 60% of our patients are going to have collarettes and have Demodex blepharitis. So when you know that number is really high I look for this on every single patient. And I just have the patient look down, I lift the lid, and I look at the base of the lashes. So you know, it takes about a second to do that on each side. But that information is so helpful and so simple. So that's what I want to share education-wise: that's simple. We can tuck this right into our exam, walking out of this room, I could do that, you know, with my next patient, and identify the patient and now we have a prescription therapy that is going to treat Demodex blepharitis.

Miller:
Great. How do you anticipate this approval of XDEMVY will change the treatment paradigm in patients with Demodex blepharitis?

McGee:
That's a great question. So historically, you know, patients have suffered with this for for decades. I've been practicing for 22 years. And, you know, we try to do some Band-Aid things around ocular hygiene, whether it's lid scrubs, or whether it's you know, a special kind of soap, or we're doing, you know, procedures in the office to reduce the Demodex load. But we've never been able to treat the root cause of Demodex blepharitis. So this is a very different paradigm shift.

And an example is I had a patient actually this morning, and I had already done lid debridement on her about 6 weeks ago. And she was on a steroid drop. And when I see her today, she's better, but she also has more collarettes. And so all I'm really doing is giving her some relief in between the actual disease state. So with XDEMVY, we're actually going to treat the root cause of what's causing her issues, which we've never had. So that's the paradigm shift: now we have a therapeutic drop, that's easy to take. It's twice a day; it's for 6 weeks. So it's not a long-term therapy, like some of our dry eye therapies that these—or a glaucoma patient. You know, when you put a patient on a chronic medication for the rest of their life, you lose some things with compliance. And so this is easy: Twice a day for 6 weeks. And the patients, at least in the clinical trial, experience the drop as something that they could take with very little discomfort. So those are all things that I look at, and I'm really excited. And so for this patient, I told her that we're going to have this drop hopefully by the end of August. And so I scheduled her to come back at that 6-week mark, so that I have a therapy for her to treat what's really at the root cause of all of her symptoms and her signs.

Miller:
Great. That's really exciting. Thank you so much for taking the time to chat today, Dr. McGee. I can't wait to hear more on XDEMVY, the first and only treatment option for Demodex blepharitis. Thank you.

McGee:
Thank you for having me.