FDA Approves Xdemvy, First Treatment for Demodex Blepharitis
The FDA has approved Tarsus Pharmaceuticals' Xdemvy (lotilaner ophthalmic solution 0.25%) for the treatment of Demodex blepharitis. Xdemvy, formerly known as TP-03, is the first and only FDA approved treatment to directly target Demodex mites, the root cause of Demodex blepharitis.
“We are thrilled to announce the FDA approval of Xdemvy for the treatment of Demodex blepharitis and look forward to making this product broadly available to the millions of patients who have not had any FDA approved therapeutics for this disease,” said Bobak Azamian, MD, PhD, Chief Executive Officer and Chairman of Tarsus. “This tremendous milestone was achieved through a successful collaboration of our talented Tarsus team, countless eye care providers and the hundreds of patients who participated in our trials. We are grateful and honored for the opportunity to introduce the first and only approved therapeutic for this disease to the eye care community.”
Tarsus said it plans to hire a full sales force by the end of August, at which time the product will be commerically launched.
In a conference call with investors, Aziz Mottiwala, Chief Commercial Officer at Tarsus, said Xdemvy will cost $1,850 per prescription. Each prescription is expected to last about 1 year. Tarsus plans to launch an assistance program to keep the cost to patients at $100 or less. Tarsus expects to receive commercial provider coverage in in 2024, and Part D Medicare coverage in 2025. The company will offer discounting until insurance coverage take effect.
"We worked diligently to get to this price point. We conducted multiple rounds of payer research. We had several payer engagements. We've actually spoken with all of the payers that will provide TP-03, and without exception, they say they'll cover this drug. So we're really excited to get that access," Dr. Azamian said in an interview with EyewireTV. "And we view the price as very appropriate for Xdemvy because this drug demonstrates real value ... you give one course, six weeks, and you see lasting effects for many months. And you think about that profile, and we don't see eye drops with that profile. So this provides great value, great durability, and pharmacoeconomic value if you think about a lasting therapy versus a monthly therapy."
Tarsus also stated during the call that it established a patient distribution access system that would allow the option for the product to be sent directly to the patient, or to a local pharmacy for pick-up.
The FDA approval is based on results from two randomized, multicenter, double-masked, vehicle-controlled studies (Saturn-1 and Saturn-2), designed to evaluate the safety and efficacy of Xdemvy in 833 patients. Patients with Demodex blepharitis were randomized to either Xdemvy or vehicle at a 1:1 ratio and dosed twice daily in each eye over the course of 6 weeks.
Efficacy was demonstrated by a significant improvement in eyelids (reduction of collarettes, the pathognomonic sign of the disease, to no more than 2 collarettes per upper lid) in each study by Day 43, with some patients seeing improvement as early as 2 weeks. Additionally, the endpoints of mite eradication (mite density of 0 mites per lash) and erythema cure (Grade 0) showed statistically significant improvement at Day 43 across both studies.
In clinical trials, Xdemvy was generally safe and well tolerated. The most common ocular adverse reactions observed in the studies were instillation site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported in less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis.
“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 at Weill Cornell Medicine, New York Presbyterian Hospital. “Demodex blepharitis, easily diagnosed by the presence of eyelash collarettes, can result in ocular damage in multiple ways, including irritation, eyelash distention or loss and inflammation, which can be uncomfortable for patients. This new medicine is a positive step forward for the treatment of this disease in many patients who have been struggling for years.”
Demodex blepharitis impacts approximately 25 million eye care patients in the US – or 1 out of every 12 adults. Tarsus said there are 1.5 million patients with Demodex blepharitis already diagnosed and seeking treatment. It is a common yet often misdiagnosed or underdiagnosed eyelid disease that is caused by an infestation of Demodex mites, the most common ectoparasite found on human skin. Demodex blepharitis is characterized by redness, inflammation, missing or misdirected eyelashes, horizontal itching along the eyelid base and the presence of collarettes. Collarettes are cylindrical, waxy debris of mite waste products and eggs found at the base of the eyelashes.
For more information about Xdemvy and full prescribing information, visit www.xdemvy.com.