XDEMVY™ (lotilaner ophthalmic solution) 0.25%, the First and Only FDA Approved Treatment for Demodex Blepharitis
Clinical ResultDrug ApprovalPhase 2
Demodex blepharitis impacts approximately 25 million eye care patients in the U.S. – or 1 out of every 12 adults.
XDEMVY is indicated for all adult patients with Demodex blepharitis and is available via prescription from an eye care provider
Sales force deployed, calling on ophthalmologists and optometrists nationwide
Tarsus Pharmaceuticals, Inc.(NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, announced that XDEMVY™ (lotilaner ophthalmic solution) 0.25% is now available at pharmacies nationwide for prescription. The U.S. Food and Drug Administration (FDA) approved XDEMVY on July 24, 2023, for the treatment of Demodex blepharitis.
“We are delighted that within weeks of FDA approval, XDEMVY is now available to millions of patients with Demodex blepharitis,” said Bobak Azamian, MD, PhD, Chief Executive Officer and Chairman of Tarsus. “The efforts of our team have created incredible interest in XDEMVY, the first and only approved solution for this highly prevalent disease. I’m so appreciative of our team and our partners who’ve worked diligently to bring this product to eye care providers and patients quickly and seamlessly following regulatory approval. We are proud to introduce XDEMVY to the eye care community and look forward to its potential to significantly change the way this disease is treated.”
XDEMVY is the only FDA approved treatment to directly target Demodex mites, the root cause of Demodex blepharitis. Demodex blepharitis is characterized by redness, inflammation, missing or misdirected eyelashes, itching along the eyelid base, and the presence of collarettes. XDEMVY is a prescription eye drop that is administered with one drop in each eye twice daily (approximately 12 hours apart) for 6 weeks.
Tarsus is committed to ensuring that patients have affordable and broad access to XDEMVY and developed Tarsus Connect, a suite of assistance programs that provide financial support for eligible patients. More information about Tarsus Connect can be found on xdemvy.com or by calling: 1-866-846-3092.
About Demodex Blepharitis
Blepharitis is a common lid margin disease that is characterized by eyelid margin inflammation, redness and ocular irritation. Demodex blepharitis is caused by an infestation of Demodex mites, the most common ectoparasite found on humans and accounts for over two-thirds of all blepharitis cases. Demodex blepharitis may affect as many as 25 million Americans based on an extrapolation from the Titan study indicating 58% of patients presenting to U.S. eye care clinics have collarettes, a pathognomonic sign of Demodex mite infestation, and that at least 45 million people annually visit an eye care clinic. Demodex blepharitis can have a significant clinical burden and negative impact on patients’ daily lives. The Titan study also showed that current management tools, such as tea tree oil and lid wipes, are ineffective at targeting the root cause of Demodex blepharitis.
About XDEMVY™
XDEMVY (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, is a novel prescription eye drop for the treatment of Demodex blepharitis and is designed to target and eradicate the root cause of the disease – Demodex mite infestation. The active ingredient in XDEMVY is lotilaner, a well-characterized agent that eradicates Demodex mites by selectively inhibiting the GABA-Cl channels. It is a highly lipophilic molecule, which may promote its uptake in the oily sebum of the eyelash follicles where the mites reside. XDEMVY was evaluated in two pivotal trials collectively involving more than 800 patients. Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found XDEMVY to be neutral to very comfortable. The most common ocular adverse reactions observed in the studies were site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported by less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis.
About Tarsus Pharmaceuticals, Inc.
Tarsus Pharmaceuticals, Inc. applies proven science and new technology to revolutionize treatment for patients, starting with eye care. Tarsus is advancing its pipeline to address several diseases with high unmet need across a range of therapeutic categories, including eye care, dermatology, and infectious disease prevention. Tarsus is studying three investigational medicines in clinical trials. In addition to XDEMVY (lotilaner ophthalmic solution) 0.25%, which is FDA approved in the United States for the treatment of Demodex blepharitis, Tarsus is also investigating TP-03 for the treatment of Meibomian Gland Disease, which is currently being studied in a Phase 2a clinical trial. In addition, Tarsus is developing TP-04 for the potential treatment of Rosacea and TP-05, an oral tablet for the prevention of Lyme disease. TP-04 and TP-05 are both currently being studied in Phase 2a clinical trials to evaluate safety, tolerability, and proof-of activity.
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