Tarsus Pharmaceuticals, Inc. has received FDA approval for XDEMVY™ (lotilaner ophthalmic solution) 0.25% as a therapeutic solution for Demodex blepharitis, a common eyelid disease affecting approximately 25 million eye care patients in the U.S.
XDEMVY is a groundbreaking treatment specifically targeting the root cause of Demodex blepharitis—the Demodex mites. Through extensive clinical trials, XDEMVY has demonstrated its efficacy across multiple disease measures.
This marks a significant milestone as it is the first and only FDA-approved therapeutic for Demodex blepharitis, providing much-needed relief to millions of patients. Tarsus Pharmaceuticals aims to revolutionize eye care and address unmet medical needs, starting with Demodex blepharitis treatment. XDEMVY is expected to be available by prescription starting from the end of August 2023.
Dr. Bobak Azamian, Chief Executive Officer, and Chairman of Tarsus said:
“We are thrilled about the FDA approval of XDEMVY for Demodex blepharitis treatment and are eager to make this product accessible to the millions of patients who lacked an FDA-approved therapeutic option for this disease. This achievement is a result of successful collaboration among our dedicated Tarsus team, eye care providers, and the hundreds of patients who participated in our trials. We are grateful for the opportunity to introduce the first and only approved therapeutic for this condition to the eye care community.”
The FDA’s approval of XDEMVY is based on data from two rigorous clinical studies (Saturn-1 and Saturn-2) involving 833 patients, of which 415 received XDEMVY. Patients with Demodex blepharitis were randomly assigned to receive either XDEMVY or a placebo in a 1:1 ratio, and they applied the treatment twice daily to each eye for six weeks.
The clinical trials showed that XDEMVY significantly improved eyelids, reducing collarettes (the disease’s characteristic waxy debris) to no more than two per upper lid. Some patients even experienced improvements as early as two weeks. The studies also revealed that XDEMVY effectively eradicated mites (reducing mite density to 0 mites per lash) and cured erythema (Grade 0) by Day 43.
During the trials, XDEMVY was generally safe and well-tolerated. The most common ocular adverse reactions observed were instillation site stinging and burning, reported by 10% of patients. Other ocular adverse reactions, such as chalazion/hordeolum (stye) and punctate keratitis, were reported in less than 2% of patients.
Dr. Christopher Starr, Associate Professor of Ophthalmology, Director of Refractive Surgery, Ophthalmic Education and the Cornea Fellowship Program at Weill Cornell Medicine, New York Presbyterian Hospital, shared his enthusiasm for the new treatment:
“After years of encountering Demodex blepharitis in my practice without an effective targeted therapy, I’m thrilled to finally have a new treatment to offer my patients. This condition, characterized by the presence of eyelash collarettes, can cause discomfort and ocular damage. XDEMVY represents a significant advancement in the treatment of this disease, offering hope to many patients who have been struggling for years.”
Dr. Selina McGee, OD, FAAO, from BeSpoke Vision, commented:
“Over half of the patients in my practice suffer from Demodex blepharitis, and until now, we had no FDA-approved therapies for the disease. Many patients have endured redness, crusting, and overall ocular discomfort for years, and I am thrilled to finally be able to offer them an FDA-approved treatment.”
Demodex blepharitis affects approximately 25 million eye care patients in the U.S., making it a common yet often misdiagnosed or underdiagnosed condition. It is caused by an infestation of Demodex mites, the most common ectoparasite found on human skin. The disease is characterized by redness, inflammation, missing or misdirected eyelashes, itching along the eyelid base, and the presence of collarettes—waxy debris and mite waste products and eggs found at the base of the eyelashes.
About Demodex Blepharitis
Blepharitis is a common lid margin disease characterized by eyelid margin inflammation, redness, and ocular irritation. Demodex blepharitis is caused by an infestation of Demodex mites, accounting for over two-thirds of all blepharitis cases. It may affect as many as 25 million Americans based on an extrapolation from the Titan study, indicating that at least 45 million people visit an eye care clinic annually. Current management tools, such as tea tree oil and lid wipes, have proven ineffective at targeting the root cause of Demodex blepharitis.
XDEMVY (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, is a novel prescription eye drop designed to treat Demodex blepharitis by targeting and eradicating the root cause of the disease—Demodex mite infestation. The active ingredient, lotilaner, selectively inhibits the mite’s GABA-Cl channels, effectively eradicating Demodex mites. XDEMVY was evaluated in two pivotal trials involving more than 800 patients, meeting primary and secondary endpoints with statistical significance and no serious treatment-related adverse events.
About Tarsus Pharmaceuticals, Inc.
Tarsus Pharmaceuticals, Inc., is a company dedicated to revolutionizing treatment in various therapeutic categories, starting with eye care. Its pipeline addresses high unmet medical needs, including eye care, dermatology, and infectious disease prevention. Besides FDA approval for Demodex blepharitis treatment, Tarsus is developing TP-03 for Meibomian Gland Disease, currently in a Phase 2a clinical trial. Additionally, Tarsus is working on TP-04 for potential Rosacea treatment and TP-05, an oral tablet for Lyme disease prevention. Both TP-04 and TP-05 are currently under Phase 2a clinical trials to evaluate safety, tolerability, and proof-of-activity.
For more information, please visit: https://tarsusrx.com/