Mites in Your Eyelashes? FDA Approves First-Ever Treatment for Demodex Blepharitis
FDA Approves Xdemvy Eye Drops for Demodex Blepharitis Treatment
Relief is on the horizon for individuals experiencing itchy and crusty eyelashes caused by demodex mites. Blepharitis, an inflammatory condition characterized by red, thickened eyelids and crusted eyelashes, along with symptoms like itching, burning, stinging, and watery eyes, can have various underlying causes. Among these causes, an overgrowth of microscopic mites called demodexes residing within the eyelash follicles is the most prevalent, with no specific treatment available until now.
On July 25, the U.S. Food and Drug Administration (FDA) granted approval to Tarsus Pharmaceuticals for their product Xdemvy (lotilaner ophthalmic solution) 0.25 percent. This eye drop solution offers a targeted treatment for demodex blepharitis, addressing a condition estimated to affect around 25 million individuals in the United States, approximately 1 out of every 12 adults. This groundbreaking development brings hope to those grappling with this form of blepharitis, previously lacking a dedicated remedy.
Xdemvy Introduces an Effective Solution for Distressing Symptoms
According to Dr. Christopher Starr, a renowned ophthalmologist and consultant for Tarsus Pharmaceuticals, Xdemvy offers a safe and approved remedy for demodex blepharitis. This condition has caused prolonged discomfort for many patients, leading to unpleasant symptoms such as eye and eyelid irritation, itching, grittiness, redness, crustiness, thickened eyelids, and recurring sties and chalazia. These manifestations can significantly affect one’s appearance.
Demodex Mites: an Inherent Part of the Skin Microbiome
Demodex mites, tiny eight-legged creatures, reside on almost everyone’s body as a natural component of the skin’s microbiome. These mites dwell within hair follicles, feeding on dead skin cells and sebum to maintain the skin’s moisture.
The mere existence of demodex mites on the skin is not problematic, as they are the most prevalent ectoparasite in humans and typically do not cause symptoms. However, an excessive population of these mites in the eyelids and eyelashes can lead to pathological infestation known as demodex blepharitis. This condition manifests with various signs and symptoms such as redness, inflammation, misdirected or missing eyelashes, itching along the base of the eyelid, and the presence of collarettes—waxy debris composed of mite waste products and eggs found at the lash roots.
Risk Factors for Demodex Include Rosacea, Diabetes, and Older Age
According to Starr, demodex can affect individuals of any gender, ethnicity, or age.
A review featured in Eye Contact Lens reveals that people with rosacea or diabetes or those who are older have a higher likelihood of developing demodex. The condition is estimated to affect over 80 percent of individuals above the age of 60.
A study conducted in 2022 at an eye care clinic discovered that nearly 65 percent of individuals with glaucoma had demodex blepharitis. Moreover, around 75 percent of those who used topical tea tree oil, a common ingredient in eyelid cleansers and personal care products, were also affected by demodex.
Xdemvy Shows Promising Results in Alleviating Symptoms within 2 Weeks
The efficacy of Xdemvy, approved by the FDA, was determined through two research studies, Saturn-1 and Saturn-2. These trials involved a total of 833 participants and employed a randomized, multicenter, double-masked, vehicle-controlled approach.
Individuals with demodex blepharitis were assigned randomly to receive either Xdemvy or a placebo. Treatment involved twice-daily application (with a 12-hour gap) for a duration of six weeks.
By the end of the six-week period, participants using Xdemvy experienced significant improvement in their eyelid condition. This improvement was measured by a decrease in collarettes (the primary symptom of the disease), with most individuals having no more than two collarettes per upper lid. Notably, some participants noticed positive changes as early as two weeks into the treatment.
Moreover, both studies demonstrated statistically significant improvements in mite eradication and redness after the full six-week course of treatment.
Xdemvy Addresses the Underlying Cause of Demodex Blepharitis
Xdemvy effectively treats demodex blepharitis by eliminating the mites responsible for the condition. It is specifically designed for this purpose and is not intended for proactive use or approved for other conditions. Previously, available options primarily focused on eyelid hygiene without directly targeting the root cause, the demodex mite. While Xdemvy may not address all subjective symptoms like itching, burning, and lash loss, it has the potential to provide additional benefits beyond its primary objective of eradicating the mites.
Safety Profile of Xdemvy
During clinical trials, Xdemvy demonstrated a generally favorable safety profile with good tolerability. The primary ocular adverse effects observed were a stinging and burning sensation at the application site, reported by 10 percent of patients.
Less common adverse reactions, occurring in less than 2 percent of patients, included chalazion (sty) or hordeolum and punctate keratitis, a condition characterized by the death of small groups of cells on the eye surface. While uncomfortable, these conditions are typically temporary and easily treatable, as stated in the Merck Manual.
Similar Symptoms in Other Eye Conditions
According to Starr, Demodex blepharitis is a prevalent condition that may resemble other eye conditions such as dry eye disease or allergies. If individuals are experiencing any ocular symptoms like redness, irritation, crusting, or itching, it is advisable for them to promptly consult their eye doctor.
During a slit lamp exam, where patients are typically asked to gaze straight ahead, eye doctors can easily identify demodex blepharitis by observing the patient when they look downward, explains Starr.
Access and Cost of Xdemvy
As per a company representative, Xdemvy will require a prescription and will be accessible by the end of August.
The exact wholesale acquisition cost is yet to be determined; however, the company anticipates that insured patients will have an out-of-pocket expense of no more than $100 for the eye drops.
