Focus on the First FDA-Approved Treatment for Demodex Blepharitis

Aziz Mottiwala, chief commercial officer at Tarsus, talks about the recently launched treatment XDEMVY®, the first and only FDA-approved product for Demodex blepharitis.

Question:

Could you explain how XDEMVY® differs from other treatments available for Demodex blepharitis?

Aziz Mottiwala:

XDEMVY is unique in that it is the first and only approved FDA product for Demodex blepharitis. What’s really important is that XDEMVY gets to the root cause of disease. It actually targets and kills the Demodex mites that causes disease in over 25 million Americans. These patients suffer from these mites that cause redness, irritation, and crusting on the lids. In clinical studies, XDEMVY was shown to directly kill the mites and improve the redness and the crusting that really causes the problems for these patients.

Prior to XDEMVY being available, patients might’ve used things like lid hygiene, etc. These can only palliate or maybe remove a little bit of the debris, but they don’t get to the root cause. They don’t give good outcomes long-term. XDEMVY is the only one that’s been proven to do so on multiple endpoints, again, getting to that root cause and addressing those primary manifestations of disease.

Question:

Have you received any feedback from physicians or patients regarding the treatment?

Aziz Mottiwala:

Since approval, we’ve had over 8,000 doctors use XDEMVY on their patients, and we’ve served thousands of patients. One of the most exciting things about this launch is the feedback that we get from both doctors and patients. We hear universally that the drug has such a positive impact on these patients. A 6-week course of therapy, taking an eye drop twice a day, these patients are coming back post-treatment, their redness is improved, their crusting is gone, they feel better, [and] the doctors have tremendous confidence. [It’s] interesting because blepharitis is a disease that you can feel the patients are obviously experiencing the symptoms and the impact of the disease, but they can also see it. The doctor can see it at the slit-lamp; they can share the images with the patients.

Those are very telling when you see a red crusted lid and then 6 weeks later, you see such a profound improvement, it really speaks to the product’s ability to get to the root cause [and] improve the outcomes for the disease. I think that positive feedback that the patients are providing the doctors is really what is potentiating our continued uptake in the eye care market.

It’s also important that the drug is very safe and well tolerated. The most common side effect is the 10% burning and stinging, but it’s transient, and that’s very safe and effective compared to a lot of other eyedrops where you have burning and stinging rates that are much higher. Patients are coming back saying the drug is working, it’s comfortable, it’s tolerated, and I think doctors are seeing great success as well.

Question:

Are there any continued unmet needs for patients with Demodex blepharitis?

Aziz Mottiwala:

When we think about patients with Demodex blepharitis, this is one of the most pervasive diseases, and it affects multiple types of patients in the clinic. A lot of the early use is in patients that have been previously diagnosed or may have been just diagnosed with Demodex blepharitis. But we also know there’s tremendous overlap with patients who have dry eye disease. Almost two-thirds of patients who have dry eye disease also have blepharitis. That’s another opportunity to help physicians understand how to make that differential diagnosis and make sure that they’re treating the blepharitis component. Maybe the patient has a concomitant disease manifestation, or maybe they have been misdiagnosed. This is an opportunity to get that differential diagnosis.

Similarly, we see this with patients presenting for cataract surgery. Over half of these patients are suffering from Demodex blepharitis. There’s a true opportunity to manage these patients pre- or peri-surgically to make sure that not only are we getting them good vision from their cataract surgery, but we’re also optimizing their overall ocular health by treating and improving their lids. Again, getting rid of that inflammation, that redness, that crusting so the patient can see better but also look better and feel better.

Lastly, we see this a lot with patients that have a hard time wearing contact lenses. Demodex blepharitis is a major issue with contact lens wear. Again, if patients are having a hard time wearing their lenses, this is a great opportunity for the doctor to say, “Let me understand to see if the blepharitis is actually causing this problem.” Looking at the lids, taking the time to make that diagnosis, treating that component, and hopefully improving the outcome for the patients there as well.

There are lots of opportunities for patients that are in the practice seeking better outcomes for the doctors to take a proactive approach, screen these patients, and get them on successful treatment.

Question:

Are there any clinician knowledge gaps or education needs surrounding Demodex blepharitis?

Aziz Mottiwala:

We continue to educate the eye care community. I think there’s 2 really big opportunities that we continue to educate on. One is the overall prevalence. It’s very interesting when you start looking for this, you can’t miss it, but there are a lot of physicians that still underestimate the prevalence in their practice. We’re in there with our sales organization as well as with our medical affairs team continuing to remind the doctors to take a closer look to understand how this disease overlaps with some of the other diseases we talked about: dry eye, cataract surgery, etc. Just that closer look will elucidate that this is much more common than a lot of physicians may have previously thought.

Secondly, it’s really understanding how impactful this disease is on the patients; 90-plus percent of the patients in a recent study showed that they were suffering daily symptoms from Demodex blepharitis. This is an opportunity to really improve outcomes for patients. Reminding the doctors that, again, if you see it, that means the patient is experiencing lots of negative impacts from the disease. It’s an opportunity to get that patient a better outcome, not only improve their way their lids look and feel, but also improve other aspects of their ocular health.

Question:

Can you talk about some of the other ongoing clinical trials Tarsus is involved in?

Aziz Mottiwala:

Beyond XDEMVY for Demodex blepharitis, we have an active pipeline. We recently announced positive results from three phase 2 studies, including studies in Lyme disease and rosacea. Then relevant to the eye care community, a positive phase 2 study in meibomian gland disease. Meibomian gland disease (MGD) is actually one of the areas that Demodex mites play a big role in as well. They actually eat on the meibomian in the glands.

In this study, it gives us an opportunity to see the effect of XDEMVY twice a day on meibomian gland disease outcomes. We looked at things like lid secretions, number of glands secreting clear liquid, which are the standard measures in MGD, and we saw positive outcomes there. We look forward to continuing that development work on the MGD side of the house and providing folks updates as we progress that forward.