XDEMVY - New FDA-Approved Treatment for Demodex Blepharitis

Xdemvy: The First FDA-Approved Prescription Treatment for Demodex Blepharitis

 

 XDEMVY™ (lotilaner ophthalmic solution) 0.25%

Tarsus, a leading pharmaceutical company, has just received FDA approval for Xdemvy, the revolutionary topical therapeutic designed to combat Demodex blepharitis. Formerly known as TP-03, is a novel prescription eye drop that is designed to treat Demodex blepharitis.

This condition, frequently encountered by eyecare professionals, has long been treated with limited interventions, primarily focusing on improved lid hygiene and the use of eyelid cleansers with tea tree oil to combat mite infestation. However, the wait is finally over, as Xdemvy offers a targeted and effective solution for Demodex blepharitis!

Xdemvy is supplied as an ophthalmic solution containing lotilaner 0.25% (2.5mg/mL) in a 10mL bottle.

What is Demodex Blepharitis?

Blepharitis is a prevalent lid margin disease characterized by inflammation, redness, and ocular irritation. One specific type, known as Demodex blepharitis, is caused by an infestation of Demodex mites—the most common ectoparasites found on humans. This form of blepharitis accounts for over two-thirds of all cases and presents a significant clinical burden to affected individuals.

With an estimated 25 million Americans affected by Demodex blepharitis, its prevalence is a matter of concern. The Titan study, based on U.S. eye care clinics' data, revealed that 58% of patients exhibiting collarettes— a pathognomonic sign of Demodex infestation. Moreover, an astonishing 45 million people visit eye care clinics annually, highlighting the widespread impact of this condition on society.

Addressing Demodex blepharitis effectively remains a challenge. Conventional management tools like tea tree oil and lid wipes have shown limited success in tackling the root cause of this condition, leaving patients seeking more effective solutions.

Key Features and Benefits of Xdemvy

• Significant Reduction in Mite Infestation: Clinical trials have demonstrated that Xdemvy can dramatically reduce or eliminate mite infestations within a period of just six weeks, with noticeable improvements often seen within 15 days of use.

• Fast and Effective: When used twice daily for six weeks, Xdemvy has shown remarkable results in reducing collarettes to no more than two per upper lid by day 43. Moreover, it has also proven to eradicate mites (zero per lash) and cure erythema (grade zero) by day 43.

• Rigorous Testing and Safety: The safety and efficacy of Xdemvy were meticulously evaluated through two Phase III trials (Saturn-1 and Saturn-2), involving 833 patients who received either Xdemvy or a placebo. The results clearly demonstrated its effectiveness in treating Demodex blepharitis.

How does Xdemvy work?

Xdemvy contains the active ingredient lotilaner, which is a well-characterized agent that eradicates Demodex mites by selectively inhibiting their GABA-Cl channels. GABA-Cl channels are essential for the survival of Demodex mites, so by inhibiting these channels, lotilaner causes the mites to die.

Xdemvy is a highly lipophilic molecule, which means that it is attracted to oil. This makes it well-suited for treating Demodex blepharitis, as the mites live in the oily sebum of the eyelashes.

Clinical Trial Data

• 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.

In Saturn-1, 81% of patients experienced significant improvement in their eyelids, achieving a collarette grade of zero or one by day 43, compared to only 23% of those on placebo.

Saturn-2 showed even more promising results, with 89% of patients on Xdemvy reaching the same improvement, in contrast to only 33% of the placebo group.

Notably, within just 15 days, 68% of patients in Saturn-1 achieved complete mite eradication, while only 18% of those on placebo showed the same result.

How about adverse effects?

Xdemvy boasts an excellent safety profile, with the most common adverse reaction reported being instillation site stinging and burning, affecting only 10% of patients who received the treatment.

Severe adverse reactions were observed in less than 2% of patients and included chalazion/hordeolum and punctate keratitis.

How to use Xdemvy? 

One drop of XDEMVY 0.25% (2.5 mg/mL) should be instilled in each eye twice daily (approximately 12 hours apart) for 6 weeks.

Typically, patients are advised to follow up approximately 3 ½ months after being prescribed XDEMVY. It's recommended that patients complete the entire contents of the bottle, which usually amounts to around 8 weeks of treatment.

However, for individuals grappling with severe Demodex infestations, we suggests an off-label, in-office procedure known as microblepharoexfoliation (MBE), alongside XDEMVY, particularly beneficial for patients contending with multiple co-morbid conditions. This combination therapy aims to enhance treatment effectiveness. MBE aids in resetting the lid, establishing a fresh starting point, potentially facilitating better monitoring and tracking of collarette formation.

Indications and Usage
XDEMVY is indicated for the treatment of Demodex blepharitis.

Handling the Container: Avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to minimize contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. 

When to Seek Physician Advice: Immediately seek a physician’s advice concerning the continued use of XDEMVY if you develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions. 

Use with Contact Lenses: XDEMVY contains potassium sorbate, which may discolour soft contact lenses. Contact lenses should be removed prior to instillation of XDEMVY and may be reinserted 15 minutes following its administration.

How to get Xdemvy?

Xdemvy is now available by prescription through your eye doctor/optometrist in United States!

1. If you notice redness and crusty eyelids (known as collarettes), it's essential to schedule an appointment with an eye specialist. They are the only ones qualified to accurately diagnose Demodex blepharitis.
2. If you receive a Demodex blepharitis diagnosis, don't forget to inquire with your doctor about XDEMVY, the sole FDA-approved treatment specifically designed to target and eliminate the Demodex mites responsible for Demodex blepharitis.
3. After your doctor has submitted your prescription, a member of our pharmacy team will contact you to verify your prescription and provide assistance with insurance coverage, cost-saving options, and the choice between home delivery or a nearby pharmacy pickup.
4. Make sure to engage with the pharmacy personnel handling your prescription to facilitate the initiation of XDEMVY.

How much does Xdemvy cost?

Many patients may only need to pay $50 or even less - however, please visit the terms and conditions for payer coverage and available assistance options, and based on eligibility requirements.

 

Don't miss the opportunity to experience the first FDA-approved prescription treatment for Demodex blepharitis. Talk to your eyecare professional today to find out how Xdemvy can provide the relief you've been waiting for.

 Read the original news release here: FDA  Approves XDEMVY™ (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis