FDA-Approved Treatment for Demodex Bepharitis Shortens Treatment, Improves Quality of Life

In a four-part Managed Healthcare Executive K-Cast video series, Selina McGee, O.D., FAAO, founder and owner of BeSpoke Vision in Edmond, Oklahoma, discussed the prevalence, symptoms, diagnosis and treatment of Demodex blepharitis, an eye condition caused by the infestation of eyelid tissue by microscopic Demodex mites. McGee reviewed the treatment choices available prior to the FDA’s approval of Xdemvy (lotilaner ophthalmic solution 0.25%) last year and the advantages of this new treatment.

Prevalence

McGee noted how common Demodex blepharitis is. Some research, she said, suggests that about 25 million people in the United States are affected by Demodex blepharitis. The risk increases with age. A study published in Clinical Ophthalmology in 2022 showed that 58% of patients seen at six eye clinics had Demodex blepharitis. McGee remarked that translates to nearly 6 of every 10 patients.

Symptoms and comorbidities

Blepharitis, or inflammation of the eyelid margin, has a number of causes, but the most common is an infestation of Demodex mites of eyelid tissue. The eight-legged parasites are 0.3 millimeters long, too small to be seen with the naked eye, according to the American Academy of Ophthalmology. McGee noted that people with Demodex blepharitis may have lost eyelashes or have lashes that are misdirected, and their eyelids may be red. But she said the “biggest hallmark” is itchy eyes. Moreover, the itchiness has a distinctive pattern. When McGee asks patients with Demodex blepharitis to show where the itchiness is, they tend to trace a finger across the eyelid. The gesture is “almost pathognomonic for Demodex blepharitis,” she said.

Demodex blepharitis “can really be debilitating [for patients] depending on their symptoms,” McGee said. “It can cause a lot of issues with patients being self-conscious about the way that they feel and the way that they look,” she continued. “The bottom line is these patients are really suffering day to day.”

Diagnosis

Collarettes are a cylindrical buildup of waxy debris at the base of the eyelash. They consist of an accumulation of mite waste and other debris. “Once you see them on a patient, that’s pathognomonic for Demodex blepharitis, so the diagnosis is actually very simple,” McGee said.

McGee said they can be identified by having the patient look down and inspecting their eyelash with a slit lamp. She said her technique is to gently “tease up” the eyelid, so she has a clear view of the base of the eyelashes. McGee said slit lamp magnification typically comes at 10x (the object looks 10 times larger than it is), 16x and 25x, and she prefers 16x for viewing eyelids and eyelashes. She said eye care professionals are always pressed for time but looking for collarettes and possibly diagnosing Demodex blepharitis “doesn’t take a lot of chair time.” The belief that a diagnosis required pulling eyelashes and inspecting them has been abandoned, she said. “It was something 20 years ago we thought we had to do.”

Past treatment

McGee said she and other eye care professionals have traditionally treated people with Demodex blepharitis by addressing the symptoms. “We didn’t have anything that directly killed the Demodex mite, so we were simply trying to manage the patient’s symptoms,” she observed.

Clinicians have used a topical application of tea tree oil on the eyelid to treat Demodex blepharitis, McGee explained. Patients with Demodex blepharitis have also been treated with in-office procedures such as microblepharoexfoliation and with agents that contain okra extract. Microblepharoexfoliation can help reduce the waste and, thus, collarettes, said McGee, noting that collarettes are proinflammatory so they shouldn’t be left on the eyelids.

“But here’s the challenge with it,” she said. “When we do that procedure, it’s not actually treating the Demodex mite. It’s not killing the mite. While we are removing all of that waste product that is proinflammatory, their problem comes right back. Depending on the patient, depending on their mite load, they might get a benefit for two to four weeks, maybe four to six weeks. And then we’re doing another procedure and those procedures are not covered by insurance.” Each treatment costs between $75 and $150, or more, she said. The expense adds up quickly, not to mention the patient’s time to come into the office for the treatment, McGee said.

Greater adherence

The FDA approved lotilaner ophthalmic solution 0.25%, marketed under the name Xdemvy, in July 2023. McGee stressed that is the first and only treatment for Demodex blepharitis approved by the FDA, and that approval instills confidence in the medication in her and her patients.

One of the major differences between Xdemvy and previous treatments is the treatment’s limited duration, McGee said. According to the FDA-approved package label, it should be administered as one drop in each eye twice a day for six weeks, whereas previous treatments could drag on for months or longer.

Adherence is much easier for patients with Xdemvy, said McGee. “The fact that it’s twice a day, that’s easy to incorporate into someone’s routine, morning and evening,”
she observed.

Clinical trials

The safety and efficacy of Xdemvy was evaluated in two, six-week, multicenter randomized controlled trials, Saturn-1 and Saturn-2. A total of 833 participants were evaluated, 415 of whom were treated with Xdemvy. Efficacy was defined as a reduction to no more than two collarettes per upper eyelid in each study.

In Saturn-1, 44% of the patients randomly assigned to treatment with Xdemvy had two collarettes or less at day 43 compared with 7% of those assigned tothe control group.

In Saturn-2, 55% of those randomly assigned to treatment with Xdemvy reached that same end point at day 43 compared with 12% in the
control group.

McGee mentioned the positive results on the secondary end points of eyelid erythema and mite eradication.

“When I can lean on a clinical trial, … that gives me confidence in being able to treat the patient and knowing what I should be looking for in the result with the patient,” McGee said.

Prior authorization

Because Xdemvy is the only FDA-approved therapy for Demodex blepharitis, McGee said prior authorization should benot be necessary. “The reason that I move straight to lotilaner 0.25% for Demodex blepharitis is because it’s the only thing that actually treats the root cause,” she said. Delays in treatment use up time in her clinic, she said.Alternatives to Xdemvy can also mean multiple care visits for the patient, loss of work time and productivity, and decrease in their quality of life,
McGee said.

Patient journeys

Until Xdemvy became available, McGee said, she had not been able to help patients with Demodex blepharitis in an effective manner.

“We have about 150 eyelashes on our upper lid. [When] you see someone who has close to 100 lashes, or 150 lashes just covered with this debris that we know is proinflammatory, when they’re itchy — [the patient is] just miserable,” she said.

McGee continued: “When I have an effective therapy that I can employ twice a day for six weeks, and they come back at that six-week mark, and to see how their eyelids look so much different, to see a reduction in their symptoms, to see that they have more self-confidence because of the way that they look and that they feel, that has been really inspiring.”