Bobak Azamian, MD, PhD, the Chief Executive Officer and Chairman of Tarsus Pharmaceuticals, sat down with Practical Dermatology© magazine recently on an auspicious day for the company: the day that he and his colleagues rang the Nasdaq Stock Market Closing Bell in celebration of the launch of Xdemvy (lotilaner ophthalmic solution) 0.25% for the treatment of Demodex blepharitis.
Dr. Azamian cofounded Tarsus Pharmaceuticals, Inc. with Michael Ackermann in November 2016, largely to address unmet needs across ophthalmology, dermatology, and other specialties.
A Pivotal Moment
“This is such a pivotal moment for Tarsus. We have the right science, the right team, and the right focus to make a meaningful difference in eyecare and have an impact as we expand into other therapeutic areas like dermatology.”
Filling unmet needs
“Approximately 25 million Americans have Demodex blepharitis, and 7 million have actively gone to the eye doctor and have not gotten a solution. Xdemvy targets Demodex mites, the root cause of Demodex blepharitis. We are working to secure reimbursement but are confident about potential coverage. We also developed Tarsus Connect, a suite of assistance programs that provide financial support for eligible patients
The company is also looking at Meibomian Gland Disease (MGD), which occurs when the meibomian glands do not secrete enough high-quality oil to lubricate the surface of the eyes, resulting in dry eye, irritation, and fluctuating vision. Like Demodex blepharitis, MGD is widely believed to be driven by an infestation of Demodex mites. Xdemvy is currently in phase 2 development as a potential treatment for MGD.
Another potential target for lotilaner is papulopustular rosacea. Demodex mites have also been reported as highly prevalent in the skin of patients with rosacea, including those with papulopustular rosacea, and may play a key role in triggering inflammatory responses associated with the disease.”
Collaboration With Dermatologists
“There’s natural crosstalk between dermatologists, optometrists, and ophthalmologists when it comes to MGD, Demodex blepharitis, and rosacea. Once these medications are in the orbit, eye doctors can refer patients out to dermatologists and vice versa. If an ophthalmologist diagnoses Demodex blepharitis with a slit lamp and notices rosacea around the patient’s nose, they can refer out to a dermatologist. By contrast, if a dermatologist notices that a rosacea patient’s eyelids look red, they can refer to an eye doctor. There is often overlapping disease in the same patients.”
Eye on Lyme Disease
“As many as 400,000 people are diagnosed with Lyme disease in the United States each year, and more than 30 million Americans are considered to be at high or moderate risk of contracting Lyme disease. There is no FDA-approved pharmacologic option for prevention yet. We are developing TP-05, an oral, systemic formulation of lotilaner for the prevention of Lyme disease. Lotilaner is an anti-parasitic agent that selectively inhibits parasite-specific GABA-CI channels. Results from a phase 2a study using TP-05 for the prevention of Lyme Disease are expected in the second half of 2023. This trial is a randomized, double-blind trial that will evaluate the efficacy of TP-05 in killing sterile, non-disease-carrying ticks after they have attached to the skin of healthy volunteers, as well as confirm the safety, tolerability, and blood concentration of TP-05.
The near-term focus is to prevent Lyme disease, but there are several other tickborne illnesses that we may target and prevent.”
Bright future
“We aim to have multiple molecules in our pipeline that can engrain us deeper and deeper into the eye care community and allow us to partner with dermatologists and infectious disease specialists. Our first chapter was all about proof of concept, which we have demonstrated with lotilaner. The second chapter is the approval chapter which is just ending. Now, we are starting the third chapter where we are serving new categories of patients who have no drugs to date.”
