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FDA Approved Xdemvy, First Treatment for Demodex Blepharitis

Web Exclusives - FDA Approvals

On July 25, 2023, the FDA approved lotilaner ophthalmic solution, 0.25% (Xdemvy; Tarsus Pharmaceuticals) for the treatment of patients with Demodex blepharitis.

Lotilaner ophthalmic solution is the first and only FDA-approved drug that directly targets Demodex mites. Blepharitis is a common ocular disease characterized by eyelid margin inflammation and redness and general eye irritation. Demodex blepharitis is caused by an infestation of Demodex mites, the most common ectoparasites that live on humans.

Lotilaner is a gamma-aminobutyric acid (GABA)-gated chloride channel inhibitor that is selective for mites; lotilaner ophthalmic solution, 0.25% is designed to selectively inhibit the GABA-Cl Demodex mite channels.

“More than half of the patients in my practice present with Demodex blepharitis, and to date, we’ve not had any FDA-approved therapies to treat the disease,” said Selina McGee, OD, FAAO, Founder of BeSpoke Vision, in Edmond, OK, and Vice President, Intrepid Eye Society, in a press release. “Many patients have experienced redness, crusting, and overall ocular discomfort for years, and I am excited to finally be able to offer an FDA-approved treatment for my patients.”

The FDA approval of lotilaner ophthalmic solution, 0.25% was based on the safety and efficacy results from 2 randomized, multicenter, double-masked, vehicle-controlled studies, the Saturn-1 (phase 2b/3; NCT04475432) and Saturn-2 (phase 3; NCT04784091) clinical trials, that enrolled a total of 833 patients with Demodex blepharitis. The patients were randomized 1:1 to lotilaner ophthalmic solution, 0.25% (n=415) or to a vehicle (n=418) that was dosed twice daily in each eye for 6 weeks.

A total of 56% of the patients who received lotilaner ophthalmic solution, 0.25% achieved complete collarette cure (defined as 0-2 collarettes per eyelid) by day 43 compared with 13% of the patients who received the vehicle (P<.0001). In addition, 89% of patients in the active-treatment arm achieved a significant, clinically meaningful collarette cure (defined by a collarette grade of 0 or 1) by day 43 compared with 33% of the patients who received the vehicle (P<.0001).

Moreover, there were improvements in the secondary end points after the patients received treatment with lotilaner ophthalmic solution, 0.25% by day 43 compared with the vehicle, including mite eradication (defined as a mite density of 0 mites per lash), which was 52% versus 14%, respectively (P<.0001); complete cure of lid erythema at 31.1% versus 9%, respectively (P<.0001); as well as complete composite cure based on collarette cure and erythema cure at 19.2% versus 4%, respectively (P<.0001).

“After years of seeing Demodex blepharitis in my practice without an effective way to target the root cause of the disease, I’m so pleased to have a new treatment to offer my patients,” said Christopher Starr, MD, Associate Professor of Ophthalmology, Director of Refractive Surgery, Ophthalmic Education and the Cornea Fellowship Program, Weill Cornell Medicine, New York Presbyterian Hospital, in a press release. “Demodex blepharitis, which is easily diagnosed by the presence of eyelash collarettes, can result in ocular damage in multiple ways, including irritation, eyelash distention or loss, and inflammation….This new medicine is a positive step forward for the treatment of this disease,” he added.

The most common ocular adverse events with lotilaner ophthalmic solution, 0.25% included administration-site pain, stinging, and burning, which were reported by 16 (7%) patients. Other adverse events that were reported by <2% of patients included chalazion or hordeolum (stye) and punctate keratitis.

Lotilaner ophthalmic solution contains lotilaner 0.25% (2.5 mg/mL). The recommended dose of lotilaner is 1 administration of the solution in each eye twice daily approximately 12 hours apart for 6 weeks. If more than 1 topical ophthalmic drug is being received, the drugs should be administered at least 5 minutes apart. If a dose is missed, treatment with lotilaner should continue with the next scheduled dose.

Lotilaner ophthalmic solution, 0.25% has no contraindications.

Patients should avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface to minimize the contamination of the solution. Serious damage to the eye and subsequent loss of vision may result from the use of contaminated solutions.

Because lotilaner ophthalmic solution, 0.25% contains potassium sorbate, which may discolor soft contact lenses, patients who wear such lenses should remove them before administering lotilaner ophthalmic solution, 0.25%; patients may reinsert the contact lenses 15 minutes after administering treatment with lotilaner.

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Last modified: September 11, 2023