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FDA Approves XDEMVY™ (Lotilaner Ophthalmic Solution) 0.25% for Demodex Blepharitis Treatment

Wednesday, July 26, 2023

Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS) has received approval from the U.S. Food and Drug Administration (FDA) for XDEMVY™ (lotilaner ophthalmic solution) 0.25%. This groundbreaking treatment is designed to address Demodex blepharitis, making it the first FDA-approved therapy to specifically target Demodex mites, which are the root cause of this condition.

The FDA approval was granted based on the positive outcomes of two clinical trials, Saturn-1 and Saturn-2, involving 833 patients, with 415 patients receiving XDEMVY. These trials demonstrated significant improvement in eyelids, characterized by a reduction in collarettes (a hallmark sign of Demodex blepharitis) to no more than 2 collarettes per upper lid by Day 43. Some patients even experienced improvement as early as 2 weeks. Additionally, both studies showed statistically significant improvement in mite eradication (reducing mite density to 0 mites per lash) and erythema cure (Grade 0) at Day 43. XDEMVY was found to be generally safe and well-tolerated, with only mild ocular adverse reactions reported in a small percentage of patients.

Demodex blepharitis is a common but often misdiagnosed eyelid disease affecting around 25 million eye care patients in the U.S. (approximately 1 out of every 12 adults). It is caused by an infestation of Demodex mites, the most common ectoparasite found on human skin. Symptoms of Demodex blepharitis include redness, inflammation, missing or misdirected eyelashes, itching along the eyelid base, and the presence of collarettes - waxy debris of mite waste products and eggs at the base of the eyelashes.

With the approval of XDEMVY, Tarsus Pharmaceuticals aims to address the unmet needs of patients suffering from Demodex blepharitis and provide eye care professionals with an effective FDA-approved therapeutic option to alleviate the discomfort and symptoms associated with this condition.

Demodex blepharitis is a common inflammation of the eyelid margins characterized by redness and ocular irritation. It is caused by an infestation of Demodex mites, which are ectoparasites commonly found on humans. This condition accounts for over two-thirds of all blepharitis cases, impacting a significant number of individuals.

Based on the Titan study, it was estimated that around 25 million Americans could be affected by Demodex blepharitis. The study found collarettes, pathognomonic signs of Demodex infestation, in 58% of patients visiting U.S. eye care clinics. With approximately 45 million people visiting eye care clinics each year, Demodex blepharitis remains a noteworthy health concern.

Patients with Demodex blepharitis experience a considerable clinical burden, affecting their daily lives. Conventional management tools like tea tree oil and lid wipes have proven ineffective in targeting the root cause of the condition.

To address this issue, XDEMVY™ (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, was developed as a novel prescription eye drop specifically designed to treat Demodex blepharitis. Its active ingredient, lotilaner, effectively eradicates Demodex mites by selectively inhibiting the mite's GABA-Cl channels. Lotilaner's high lipophilicity enables it to penetrate the oily sebum of the eyelash follicles where the mites reside.

XDEMVY underwent two pivotal trials involving over 800 patients, meeting both primary and secondary endpoints with statistical significance. Importantly, no serious treatment-related adverse events were reported. Most patients found the XDEMVY eye drop to be comfortable during use.

While some patients reported mild ocular adverse reactions such as instillation site stinging and burning (10%), other reactions like chalazion/hordeolum (stye) and punctate keratitis were less common, occurring in less than 2% of patients.

In conclusion, XDEMVY represents a promising treatment option for Demodex blepharitis, offering a potential solution to eradicate the root cause of the condition and alleviate the burden experienced by affected individuals. As always, patients should consult their eye care professionals to determine the most appropriate course of treatment for their specific condition.

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