It has been estimated that 55 to 58% of all patients seeking eyecare have Demodex blepharitis (DB), making up a potential total of 25 million cases.1
Until recently, eyecare professionals (ECPs) had to rely on a variety of palliative therapeutic approaches to manage DB; however, the treatment paradigm has quickly evolved since the US Food and Drug Administration (FDA) approval and launch of XDEMVY in the summer of 2023.
Designed to address the unmet need for targeted therapies to treat ocular demodicosis, Preeya K. Gupta, MD, and Doug Devries, OD, discuss their experiences with prescribing XDEMVY (lotilaner ophthalmic solution 0.25%, Tarsus Pharmaceuticals) and offer clinical pearls for identifying DB in patients to potentially optimize patient outcomes.
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Screening patients for Demodex blepharitis
To start, Dr. Devries noted that he didn’t realize how significant a portion of the irritation and inflammation in ocular surface disease (OSD) patients that he managed was caused by DB until he was able to effectively treat it.
As we know, DB is known to trigger and exacerbate other forms of OSD, particularly dry eye disease (DED) and meibomian gland dysfunction (MGD).2 This makes it a crucial initiative for surgeons to proactively screen patients for this condition, ranging from comprehensive examinations to pre-operative planning for cataract (and refractive) surgery and/or a microinvasive glaucoma surgery (MIGS) procedure.
Assessing patients for DB is also relatively easy, added Dr. Devries, because it simply requires asking the patient to look down and assessing their lash line for collarettes. Even if there are minimal collarettes, he has elected to implement treatment earlier in the disease process to control the level of irritation and inflammation as soon as possible.
Changing the threshold to initiate DB therapies
With a targeted treatment now available, both Drs. Gupta and Devries agreed that they have lowered the threshold to initiate DB treatment. In part due to the understanding that some patients may have accepted a certain level of discomfort and irritation as their baseline.
This means that they may initially report being asymptomatic but, following treatment, notice significant improvements in their symptoms—resulting in the establishment of a new benchmark.
Dr. Devries recounted a story highlighting this point about an active retired senior patient of his with relatively severe DB. He asked her during the exam whether she ever felt the need to scratch her eyelids; as she thought about her response, she began pulling at her lashes on one eye.
She then responded no; she never felt the urge to rub her eyelashes. Dr. Devries asked her if she was sure, and she repeated the gesture with the other eye. When he pointed out what she was doing, she laughed—apparently, she had not been aware of this behavior.
Further, some patients may already perform at-home eyelid hygiene treatments, such as warm compresses and lid scrubs. Consequently, the surgeon may see a low load of collarettes during the exam, but without the at-home treatments, it could be notably worse. As such, prescribing XDEMVY has the potential to effectively and safely target, paralyze, and kill Demodex mites.
What is XDEMVY?
While hygiene-based treatments can reduce the inflammation caused by Demodex, they do not address the root cause of DB—the mites. Conversely, XDEMVY is a lotilaner eye drop that inhibits parasite-specific GABA-CL channels, causing mite paralysis and death.1
Lotilaner is an antiparasitic agent with high lipophilicity, allowing it to be quickly absorbed into the eyelash follicles and meibomian glands, where the mites tend to inhabit within the ocular surface environment.1
In two phase 3 studies (SATURN-1 and SATURN-2), XDEMVY significantly improved Demodex blepharitis through three primary endpoints:4-6
- Mite eradication: 60% of patients taking XDEMVY achieved complete mite eradication, defined as 0 mites per lash, compared to 16% of patients taking the vehicle.
- Collarette reduction: 50% of patients taking XDEMVY had complete collarette cure defined as <2 collarettes on the upper lid compared to 10% of patients taking the vehicle.
- Clinically meaningful collarette cure was defined as <10 collarettes and was reported in 85% of patients taking XDEMVY compared to 28% of patients taking the vehicle.
- Improvement of eyelid erythema: 25% of patients taking XDEMVY exhibited erythema cure defined as grade 0 or no lid margin erythema on a 0 to 3 scale compared to 8% of patients taking the vehicle.
XDEMVY is dosed twice a day for 6 weeks, though some patients may experience improvements in ocular demodicosis as early as 2 weeks.3 Both Drs. Gupta and Devries highlighted that in their experience, XDEMVY is generally very well-tolerated.
Of note, 90% of patients reported that it was neutral to very comfortable during clinical trials, and the most common adverse reaction was stinging and burning upon instillation, which was reported in 10% of patients.4-6
XDEMVY in clinical practice
The 6-week treatment course of XDEMVY corresponds to around two life cycles of the mites,3 and represents a change of pace for many patients because it is not a “forever therapy,” mentioned Dr. Gupta.
With age, the prevalence of DB tends to increase, often resulting in patients with multiple co-morbidities (i.e., glaucoma, dry eye, MGD) that may impact treatment. Consequently, most patients are not commonly interested in polypharmacy to manage their symptoms indefinitely.
Educating patients on Demodex blepharitis requires a direct approach, emphasized Dr. Devries, wherein the clinician clearly states that the inflammation and irritation they see is the result of a microorganism that lives within the eyelashes.
He added that he doesn’t “soften the blow” by being vague about Demodex mites because patients tend to have a visceral reaction to being told there are parasitic mites on their eyelids—motivating them to pursue treatment.
Dr. Devries tends to follow up with patients around 3 ½ months after XDEMVY is prescribed and recommends to patients that they finish the entire contents of the bottle (~8 weeks of treatment).
Adjunctive treatments with XDEMVY to manage DB
While XDEMVY can directly address Demodex mites, it was not designed to remove collarettes, Dr. Devries stated. As such, he also recommends that patients use a lid-cleansing foam in the shower once daily to remove some of the collarettes and then reevaluate their eyelid health after the course of treatment.
For patients with more severe Demodex infestations, Dr. Gupta recommends off-label, in-office microblepharoexfoliation (MBE) in tandem with XDEMVY, especially for those with multiple co-morbid conditions, to complement the therapy. MBE can help reset the lid and start at a clean baseline, which might help with monitoring and tracking collarette formation, she noted.
She also emphasized that the majority of her DB patients have mixed-mechanism disease with DB, aqueous deficient dry eye, evaporative dry eye, and more—which requires layered treatments to address the patient’s multifactorial symptoms. For example, in certain patients, Dr. Gupta pairs microblepharoexfoliation with meibomian gland expression and XDEMVY to address multiple root causes of their discomfort.
Patient selection for XDEMVY
Dr. Devries prescribes XDEMVY for most patients with signs and symptoms of DB, with the potential exception of those utilizing polytherapy due to co-morbid conditions. In this extraordinary case, he weighs the level of priority in treating DB compared to the treatment of the other conditions and then determines whether certain interventions may supersede topical therapies.
If Dr. Devries notes the presence of any amount of collarettes on any surgical patients, he initiates treatment with XDEMVY immediately, as well as lid hygiene in the morning prior to application.
For surgeons who might be learning about XDEMVY for the first time, Dr. Gupta recommended that they initially look for signs of DB in patients and then develop a confidence level with prescribing the medication on a regular basis, dependent on case severity, as it will likely be an enduring treatment.
Conclusion
It is easy to miss something you are not looking for, and as the “Great Masquerader of OSD,” it is paramount that surgeons take the time to ensure that they examine patients for DB by having them look down and check their lash margin for collarettes.
As the first and only FDA-approved treatment indicated for the management of DB, XDEMVY has fundamentally shifted the treatment paradigm for eyelid health, offering surgeons another avenue to enhance patient care.
