Blepharitis, a bothersome inflammatory disorder, is known for causing red, thickened eyelids, crusty eyelashes, and discomfort such as itching, burning, stinging, and watery eyes.
The American Optometric Association (AOA) identifies various causes, including bacteria, clogged oil glands, and notably, an overgrowth of microscopic mites called demodexes residing in eyelash follicles.
Until recently, there was no specific treatment for demodex blepharitis. However, on July 25, the U.S. Food and Drug Administration (FDA) approved Xdemvy (lotlaner ophthalmic solution) 0.25 percent, develop by Tarsus Pharmaceuticals, as the first treatment for this specific type of blepharitis.
Demodex blepharitis affects around 25 million in the United States, or 1 in 12 adults, as reported in a review published in August 2023 in Eye & Contact Lens. Xdemvy offers relief from symptoms associated with demodex blepharitis.
Xdemvy Provides Relief from Troublesome Symptoms
According to Christopher Starr, MD, an associate professor of ophthalmology, the director of refractive surgery, ophthalmic education, and the Cornea Fellowship Program at Weill Cornell Medicine New York-Presbyterian Hospital, and a consultant for Tarsus Pharmaceuticals, “Xdemvy presents a new, safe, and effective FDA-approved solution for demodex blepharitis.”
Dr. Starr says, “Many patients have been struggling with this disease for years, without long-term relief. They have significant symptoms which make their eyes and eyelids uncomfortable, gritty, and itchy, and overt signs like redness, crusting, lid thickening, eyelash loss, and recurring sties and chalazia, all of which can have an adverse impact on one’s outward appearance.”
Demodex Mites Constitute an Integral Component of the Skin Microbiome
Demodex mites are a natural part of the skin’s microbiome, residing in hair follicles and consuming dead skin and sebum. The issues arises when there’s an overpopulation of these mites in the eyelids and eyelashes, leading to pathologic infestation and the associated signs and symptoms.
Dr. Starr explains that while the presence of the demodex mites on your skin isn’t an issue, these mites are the most common type of ectoparasite found in humans, which normally don’t create symptoms.
He says, “An overpopulation in the eyelids and eyelashes leads to pathologic infestation, causing the signs and symptoms associated with demodex blepharitis.”
Symptoms include redness, inflammation, missing or misdirected eyelashes, horizontal itching along the eyelid base, and the presence of collarettes – waxy debris composed of mite waste products and eggs found at the base of the eyelashes.
Diabetes, Rosacea, and Older Age Are Risk Factors
“This disease can impact anyone — any gender, ethnicity, or age,” says Starr.
Certain factors, such as rosacea, diabetes, and aging, increase the risk of demodex infestation. Over 80 percent of people over 60 are estimated to have the condition, says Eye & Contact Lens.
One study published in 2022 shared how individuals who visited an eye care clinic for any reason also found that almost 65 percent of those with glaucoma had demodex blepharitis, while nearly 75 percent of those who used topical tea tree oil did.
Tree tea oil is a common ingredient used in a number of personal care products, such as marketed eyelid cleansers.
Participants’ Saw Some Improvements Using Xdemvy in 2 Weeks
Xdemvy’s FDA approval is grounded in the outcomes of two randomized multicenter, double-masked, vehicle-controlled studies, namely Saturn-1 and Saturn-2, encompassing a total of 833 participants.
Individuals with demodex blepharitis were randomly assigned to either Xdmevy or a placebo, applying them twice daily with a 12-hour interval for six weeks.
Those administered Xdemvy witnessed notable enhancements in their eyelids, characterized by a reduction in collarettes – the hallmark symptom of the condition – to no more than two collarettes per upper lid by the conclusion of the six-week period.
Some participants experienced improvement as early as two weeks. Furthermore, both studies demonstrated statistically significant advancements in mite eradication and reduction of redness after six weeks.
Xdemvy Addresses the Root Cause of Demodex Blepharitis
According to Dr. Starr, the existence of collarettes, the waxy and crusty accumulatio at the base of the eyelash margin, unequivocally indicates the presence of demodex mites. An eye doctor can readily observe them during a routine eye examination.
“Since Xdemvy kills the mites causing the disease, it’s not meant to be taken proactively, nor is it approved for any other condition other than demodex blepharitis. It’s very specific to this disease, which is great, because until now, there has been nothing that really targets the underlying cause,” he says.
In the past, the primary focus of managing the disease revolved around maintaining eyelid hygiene through practices like using cleansing wipes, exfoliation, and warm compress.
However, according to Dr. Starr, most conventional approaches, including traditional antibiotics, proved ineffective in addressing the fundamental cause of the condition – the demodex mite itself.
“Demodex blepharitis can be cured, but there is always the potential for recurrence or reinfestation,” he says.
Dr. Starr also explains that the Xdemvy trial specifically targeted mites, collarettes, and redness as endpoints, without addressing some of the subjective symptoms commonly encountered by patient with demodex blepharitis, such as itching, burning, and lash loss.
“That said, the drug is designed to target the root cause of the disease and the primary element causing all of these problems — the mite. So it is likely that patients may experience benefits in other areas after taking it,” he says.
Xdemvy Safety
During clinical trials, Xdemvy demonstrated overall safety and good tolerability. The most prevalent ocular adverse reactions noted in the studies were stinging and burning sensations at the drop application site reported by 10 percent of patients.
Additional adverse reactions, affecting fewer than 2 percent of patients, included chalazion or hordeolum (stye) and punctate keratitis – a condition characterized by the death of small groups of cells on the eye’s surface. While uncomfortable, these reactions are typically easily treatable and temporary, as stated in the Merck Manual.
Different Condition With Comparable Symptoms
Dr. Starr shares that Demodex blepharitis is an extremely common disease that can be confused with other ocular conditions, like dry eye disease or allergies.
“If a patient is experiencing any ocular symptoms such as redness, irritation, crusting, or itching, they should visit their eye doctor as soon as possible,” he adds.
Eye doctors can diagnose demodex blepharitis through a slit lamp exam, where patients look down to reveal the presence of collarettes, explains Dr. Starr.
Pricing and Access to Xdemvy
Xdemvy will be available by prescription by the end of August.
While the wholesale acquisition cost is yet to be determined, the company expects patients with insurance to pay no more than $100 out-of-pocket for the eye drops.
Recommended For You
