Tarsus anticipates late 2023 launch of Demodex therapy, expansion into MGD, Lyme, rosacea
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NEW YORK — A Tarsus executive said the company is looking forward to FDA approval of TP-03, a 0.25% lotilaner ophthalmic solution for treatment of Demodex blepharitis, in late summer 2023.
In an interview during Vision Expo East, Aziz Mottiwala, MBA, Tarsus chief commercial officer, told Healio, “We’re anticipating approval in August — that’s our [Prescription Drug User Fee Act] date,” he said. “If all goes well, we’re planning on having the product launch before the end of the year, so we’ll have it in doctors’ and patients’ hands this year.”
As the company prepares for the approval and launch, Mottiwala said it is focused on three areas: building its team, educating the market and laying the foundation for reimbursement. In preparation, the company is bringing together people with deep eye care experience, as well as those with product launch and category creation experience.
“This is not just a product launch, but it’s also introducing a new category into the eye care space,” Mottiwala said.
The company’s “Look at the Lids” campaign will be complemented by its medical ambassador team, which will include optometrists with clinical experience who will help educate the rest of the eye care community, he said.
“We have a payer team talking to all major U.S. payers,” Mottiwala added, “so when the product comes out, we can get coverage and it can be affordable and accessible to patients.”
Tarsus is also evaluating the use of TP-03 to treat meibomian gland disease (MGD) in a phase 2 study expected to be completed this year.
“The same mites that cause Demodex blepharitis are thought to be implicated as one of the root causes of MGD,” Mottiwala said. “The mites burrow into the meibomian glands. There they can cause irritation, inflammation, obstruction of the glands, so they’re thought to contribute pretty significantly to disease.
“If all goes well in that study, that can set a path forward to have a definitive product for multiple lid diseases.”
Although not related to eye care, Mottiwala said Tarsus is also investigating prophylaxis for Lyme disease.
“You take a tablet before the season or before you’re going somewhere you’re at risk for exposure,” he said. “If you get bit by a tick, the drug would kill the tick before it could transmit the bacteria that causes Lyme. It’s a really innovative application of our drug to solve another really big health care problem.”
Lastly, the company is considering a treatment for rosacea, another mite-driven disease.
“The idea is, if we could formulate this in a topical form, like a gel, this could be used to treat the underlying cause of two-thirds of rosacea,” he said.
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