Where Are They Now? Tarsus Pharmaceuticals

By Ben Comer, Chief Editor, Life Science Leader

Then: In the May 2023 issue of Life Science Leader, Bobak Azamian, MD, Ph.D., cofounder and CEO of Tarsus Pharmaceuticals, talked about the company’s formation in 2016, and the decision to focus on the eyelid as a drug target, and on demodex blepharitis — an inflammatory condition caused by an overabundance of demodex mites — as a specific condition to treat. The Tarsus team assembled a spreadsheet of roughly 150 different molecules, matrixed by safety, effectiveness, IP, and a range of other criteria. “Our thesis was that we don’t need to discover a new molecule; there is plenty of great chemistry out there that we can bring in,” said Azamian.

In 2018, the company raised a Series A without having selected a drug to develop. Then, during the process of selecting a candidate to in-license and develop, serendipity struck: a Tarsus cofounder’s sister worked as a veterinary dermatologist. She expressed an interest in testing some of the compounds Tarsus was considering in her veterinary clinic, since demodex mites also cause skin disease, or mange, in dogs and cats, but there was a problem. Skin disease and mange had been largely eradicated in the animals she treated, due to a widely prescribed class of animal health drugs called isoxazolines. “Once we heard that, we knew that we had to find out more about these drugs,” said Azamian. “And that’s what led us to lotilaner.”      

 Lotilaner had never been used in humans, but it was, and is, the active ingredient in Elanco’s Credelio, an animal health product used to prevent fleas and ticks. Azamian said Elanco worked collaboratively with Tarsus to license the drug and bring it into human medicine. At the time the article was published, Tarsus was four months away from its PDUFA date for lotilaner (TP-03), which had been reformulated as an eye drop for the treatment of demodex blepharitis.

Since no existing product had ever been approved for demodex blepharitis, Tarsus focused on educating optometrists and ophthalmologists about the condition, which presents as white waxy buildup around the base of the eyelashes, as well as red, swollen, dry, or itchy eyes. “If we don’t educate the eyecare professionals then patients aren’t going to be treated,” said Azamian. “And we know that payers are really critical to engage.”       

Now: You may have seen the TV spot — created by FCB Chicago — for Xdemvy (lotilaner), which was approved by FDA in July 2023, ahead of its PDUFA date. By the end of 3Q 2024, Tarsus had delivered 104,000 bottles of Xdemvy, and had earned over $113 million in net product sales. Over 80% of commercially insured and Medicare insured patients are covered for the treatment, and Tarsus aims to grow the product to over $1 billion in annual sales.

In an interview during the JPMorgan Healthcare Conference, Aziz Mottiwala, chief commercial officer at Tarsus, described a “tremendous amount of educational effort, even before the launch,” to help eye care professionals understand demodex blepharitis, the drug, and the benefits it confers. The three key objectives at launch, said Mottiwala, were to educate the physician audience, build good access for patients, and continue to create good evidence to support the use of the product. “We talked to about 15,000 doctors, and as of the third quarter of 2024, we had 13,000 doctors, or well over 85% of our intended audience, actually prescribe the product within the first year of launch.” On patient access, “most patients are paying under $100 for a full [six-week] course of treatment," and the development of scientific evidence supporting the product is robust and ongoing, said Mottiwala. In fact, Tarsus announced plans in January to initiate a Phase 2 study during the second half of 2025 for ocular rosacea, a second condition affecting between 15 and 18 million people in the U.S. Ocular rosacea is characterized by inflammation and redness on the skin around the eye, which also can be caused by demodex mites proliferating in facial pores. For that indication, Tarsus developed a sterile ophthalmic gel formulation of lotilaner.

Mottiwala credits time spent out in the field with eye care specialists as the catalyst for Tarsus’s ocular rosacea development program. “Doctors told us, ‘We’re having great success with Xdemvy in the eyelid, but is there anything we can do to help with the redness and irritation around the eye?’ That insight helped to guide the idea that we can pursue a new indication in ocular rosacea.” Tarsus is also pursuing approval in global markets: a partner has completed registrational studies and filed an NDA in China, said Mottiwala, and the company is also exploring market entrance in Europe “and potentially Japan,” anticipating a potential European approval “as early as 2027.”

The net sales figures for Xdemvy mentioned above occurred before the launch of the brand’s consumer campaign late last year, including the TV spot. “We didn’t want to use scare tactics, like ‘Hey, you have bugs in your eyes.’ We wanted to normalize it and show that lots of people have this disease. But the good news is, the bug is the root cause, which means we can kill it,” said Mottiwala. For the consumer materials, “we like to have a little bit of fun, but we didn’t want [the DTC creative] to be slapstick … we want it to be credible and impactful, and I really credit the team, because that’s not an easy balance to strike.”      

A key driver of the development of the consumer campaign was the insight that patients want to be empowered by understanding their own condition, said Mottiwala. Patients “don’t get freaked out … they have a true desire to understand the root cause of their disease,” which translates to advertising materials that anthropomorphize the demodex mite. “We wanted to do it in a way that doesn’t exaggerate the condition or make fun of it, and that was very motivating to patients,” said Mottiwala.