TP-03 Now Approved in China for the Treatment of Demodex Blepharitis
Key Takeaways
TP-03 (XDEMVY) has been approved in China by the NMPA for treating Demodex blepharitis, marking a major expansion beyond the United States.
Tarsus’ partner, Grand Pharma, secured the approval, triggering a $15 million milestone payment to Tarsus.
TP-03 is the only approved therapy targeting the root cause of Demodex blepharitis, potentially benefiting over 40 million patients across the Greater China region.
Tarsus Pharmaceuticals announced that a $15 million milestone payment due to Tarsus has been achieved following regulatory approval of TP-03 (lotilaner ophthalmic solution, 0.25%), marketed as XDEMVY in the United States, by the National Medical Products Administration (NMPA) of the People's Republic of China.
The approval was obtained by Grand Pharmaceutical Group Limited (Grand Pharma), Tarsus’ exclusive partner for the development and commercialization of TP-03 for the treatment of Demodex blepharitis in the Greater China region, which includes the People’s Republic of China, Hong Kong, Macau and Taiwan.
“TP-03 is once again the first and only therapy approved to address the root cause of Demodex blepharitis—marking a meaningful advance for the more than 40 million people in the region affected by this disease,” said Bobak Azamian, MD, PhD, CEO and Chairman of Tarsus. “This approval underscores our commitment to bringing this much-needed treatment to patients worldwide, and we look forward to supporting Grand Pharma as they prepare for launch.”
Under the terms of the agreement with Grand Pharma, Tarsus is eligible to receive the $15 million milestone payment based on regulatory approval in China and patent issuance related to TP-03, both conditions of which have been achieved, as well as further consideration from Grand Pharma upon the achievement of additional TP-03 events. These include additional regulatory milestones, China-based TP-03 sales threshold milestones, and tiered royalties for TP-03 product sales in the Greater China region.
Originally published online on Eyewire+.