Xdemvy (lotilaner ophthalmic solution 0.25%) is a medicine designed to treat Demodex blepharitis, a common but often overlooked eye condition caused by microscopic insects called Demodex mites on the eyelids. These mites can clog oil glands, leading to inflammation, irritation, and crusty debris (called collarettes) around the base of your eyelashes. If left untreated, Demodex blepharitis can affect your quality of life by causing chronic eyelid discomfort and problems with vision. Xdemvy offers a targeted way to manage the condition, aiming to remove mites, reduce inflammation, and clear crusting from the eyelids. Xdemvy is the only FDA approved medication to treat Demodex blepharitis.
How Does Xdemvy Work?
Xdemvy contains the ingredient lotilaner, which is an antiparasitic medicine that targets the Demodex mite. Lotilaner works by blocking certain proteins in the mites’ nervous system, which leads to their paralysis and death. These proteins (called GABA-gated chloride channels) are specific to these mites and do not affect the human eye when used as directed. By clearing these mites, Xdemvy reduces the inflammation and debris that contribute to the symptoms of Demodex blepharitis.
How Do I Use Xdemvy for Demodex Blepharitis?
Use Xdemvy exactly as prescribed by your health care provider:
- Dose: Place one drop in each eye twice daily, approximately 12 hours apart.
- Treatment duration: Continue treatment for six weeks.
- If you use contact lenses: Remove them before using Xdemvy and wait 15 minutes before reinserting them.
- Multiple eye drops: If you use other eye medicines, wait at least five minutes between each product.
Be sure to wash your hands before and after applying Xdemvy. Try not to let the tip of the bottle touch your eye or any surface to avoid contamination. If you miss or forget to use a dose, use the next one as scheduled. Do not double up to make up for a missed dose.
How Was It Studied for the Treatment of Demodex Blepharitis?
Xdemvy was evaluated in two major clinical studies, Saturn-1 and Saturn-2, which included 833 people with Demodex blepharitis. These were randomized, double-blind studies, meaning participants did not know whether they were receiving Xdemvy or a placebo-like eye drop with no active medicine. Participants needed to meet the all of the following criteria present in at least one eye in order to be enrolled in the studies: signs of Demodex infestation with more than 10 upper eyelashes showing waxy or scaly buildup, at least mild redness along the edge of the upper eyelid, and an average of 1.5 or more mites per eyelash when the upper and lower lids are examined together.
The Saturn-1 trial included 421 participants. The average age was around 67, and 57% were female. The majority of participants were White (90.7%), followed by Black or African American (6.4%), Hispanic or Latino (5.9%), Asian (1.2%), and less than 1% each of American Indian/Alaska Native, Native Hawaiian/Pacific Islander, and other or multiple races. The Saturn-2 trial included 412 participants. The average age was around 64, and 48.5% were female. The racial composition was similar: Most participants were White (88.1%), followed by Black or African American (8.5%), Hispanic or Latino (8.2%), Asian (1.4%), and less than 1% each of American Indian/Alaska Native, Native Hawaiian/Pacific Islander, or multiracial individuals.
The main treatment outcome evaluated in both the Saturn-1 and Saturn-2 studies was improvement in the eyelids (grade 0, complete collarette cure), which was defined as no more than two colarettes seen on each upper eyelid. After six weeks, people using Xdemvy had much clearer eyelids, fewer mites, and less redness than those using the placebo. In the Saturn-1 study, a significantly higher number of participants (81.3%) in the Xdemvy group showed a meaningful improvement in collarettes (defined as 10 or fewer, or grade 0 or 1), compared to 23% in the placebo group. By day 43, 44% of patients in the Xdemvy group had a complete cure, while only 7.4% of people in the placebo group reached the same result.
In the Saturn-2 study, 89.1% of people in the Xdemvy group had a clinically meaningful reduction in collarettes (10 or fewer, or grade 0 or 1), while only 33% of those in the placebo group reached this level of improvement. On day 43, 56% of patients in the Xdemvy group achieved complete collarette cure (grade 0 on the upper eyelid) compared to 12.5% in the placebo group. The drops were well-tolerated in both studies, and the most common side effect was mild stinging when the drops were used.
Your results may differ from what was seen in clinical studies.
What Are Some Blepharitis Prevention Strategies?
Making a few simple changes to your daily habits may help prevent blepharitis from coming back.
Keep your eyelids clean, and always remove eye makeup before going to bed. Avoid applying eyeliner to the inner edge of your eyelids, behind your lashes. During the early stages of treatment, skip using makeup to avoid further irritation. When you do start using eye makeup again, replace any products used around your eyes, as they could be contaminated.
Including omega-3-rich foods in your diet or taking omega-3 supplements may also help. If you have dry eyes, using artificial tears can provide relief, but talk to your doctor if you need them frequently or for a long time, since over-the-counter drops aren't intended for constant use.
Are There Any Special Steps Required to Get Xdemvy?
Xdemvy is a “specialty” medicine. This means that you can only get it from a specialty pharmacy and that it may require prior authorization from your insurance company.
Is There Any Cost Assistance Available?
There are assistance options available from the drugmaker that may allow you to pay as little as $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more at xdemvy.com/savings-and-access.
