Tarsus Pharmaceuticals Advances Ocular Rosacea Program and Accelerates XDEMVY Launch
Key Insights
Tarsus Pharmaceuticals is set to initiate a Phase 2 study of TP-04 (lotilaner ophthalmic gel (search)) in the second half of 2025 for treating ocular rosacea (search).
XDEMVY (lotilaner ophthalmic solution (search), 0.25%) achieved $113 million in net product sales in the first nine months of 2024, with over 104,000 bottles delivered.
The company's direct-to-consumer advertising campaign for XDEMVY began in January 2025, coinciding with high-profile events like the Golden Globes.
Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS) has announced its strategic priorities for 2025, highlighting the advancement of TP-04 for ocular rosacea (search) and the continued expansion of XDEMVY in the eye care market. The company's announcement on January 13, 2025, underscores its commitment to addressing unmet needs in eye care and infectious disease prevention.
XDEMVY's Market Expansion
In the first three quarters of 2024, XDEMVY, a treatment for Demodex blepharitis (search), achieved significant commercial success, with over 104,000 bottles distributed and $113 million in net sales. By the end of Q3 2024, more than 13,000 eye care professionals were prescribing XDEMVY, with over 70% of them prescribing for multiple patients. Broad commercial and Medicare reimbursement now covers over 80% of insured lives, with gross-to-net discount percentages in the low 40s as of Q3 2024.
The company's recent deployment of approximately 50 new sales representatives in Q3 2024 has already begun to positively impact sales in Q4 2024. Furthermore, Tarsus initiated its first direct-to-consumer advertising campaign in January 2025, including spots during the Golden Globes and NFL playoffs, to further drive awareness and adoption of XDEMVY.
Advancing TP-04 for Ocular Rosacea
Tarsus is also focusing on TP-04 (lotilaner ophthalmic gel (search)) as a potential treatment for ocular rosacea (search), a condition affecting an estimated 15-18 million Americans and for which there is currently no FDA-approved therapy. More than half the cases are caused by Demodex mites (search). The company plans to initiate a Phase 2 study in the second half of 2025, with results expected in 2026. TP-04, an investigational topical formulation of lotilaner, is designed for application across the eyelid and surrounding tissue.
Previous clinical trials of lotilaner have demonstrated statistically significant improvements in key objective endpoint measures of diseases such as Demodex blepharitis (search), Meibomian Gland Disease (search) (MGD), and papulopustular rosacea. Tarsus anticipates patent exclusivity for TP-04 through 2038.
Additional Growth Opportunities
Tarsus is on track for potential European regulatory approval of a preservative-free formulation of XDEMVY in 2027. In Japan, the company expects to share results from an ongoing Demodex blepharitis (search) prevalence study in 2025 and engage with regulatory authorities to determine a regulatory path forward. Additionally, the New Drug Application (NDA) for TP-03 for Demodex blepharitis, submitted by Tarsus’s partner, Grand Pharmaceutical Group Ltd. (search), is under review by the Chinese regulatory agency, with a decision anticipated in 2027.
The company also plans to provide an update on TP-05, a potential preventative measure for Lyme disease (search), during the FY 2024 earnings call.
Bobak Azamian, M.D., Ph.D., CEO and Chairman of Tarsus, stated, "I expect 2025 to be even more transformational as we turn up the dial on key strategic launch initiatives, plan to generate more new evidence highlighting the impact of XDEMVY and our pipeline candidates, and pursue Ocular Rosacea (search) as the next potentially revolutionary opportunity in eye care."