Lotilaner

• Grandpharma's innovative ophthalmic drug GPN01768 has been approved by Macao's Drug Regulatory Authority for treating Demodex blepharitis, marking a significant milestone for the company's ophthalmology portfolio. • The drug is the first and only FDA-approved treatment for Demodex blepharitis, generating approximately $180 million in U.S. revenue in 2024 with strong quarterly growth momentum. • This approval establishes a foundation for future regulatory submissions in the Greater Bay Area and mainland China, where over 40 million patients suffer from Demodex blepharitis with no currently marketed treatments. • Grandpharma has exclusive rights for GPN01768 development and commercialization in Greater China through a strategic partnership with Tarsus Pharmaceuticals.

Elanco Animal Health's Credelio Quattro, a novel oral therapy combining four active ingredients, has received FDA approval for protecting dogs against six types of parasites.

• Tarsus Pharmaceuticals is set to initiate a Phase 2 study of TP-04 (lotilaner ophthalmic gel) in the second half of 2025 for treating ocular rosacea. • XDEMVY (lotilaner ophthalmic solution, 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 anticipates potential European regulatory approval for a preservative-free XDEMVY formulation by 2027 and awaits a decision on TP-03 in China.

• Miebo (perfluorohexyloctane ophthalmic solution) achieved approximately $162.6 million in sales in its first full year, with 18,000 eye doctors prescribing it, demonstrating strong market acceptance for dry eye disease treatment. • Xdemvy (lotilaner ophthalmic solution 0.25%) reached approximately $126 million in sales within its first year, with 13,000 doctors prescribing it, highlighting successful disease state awareness for Demodex blepharitis. • Clinical data indicates Miebo provides rapid relief from dry eye symptoms, with patients reporting significant improvement in as little as 3 days, while Xdemvy improves meibomian gland function and reduces related symptoms. • Both medications have secured substantial insurance coverage, with approximately 70% to 80% of insured patients having access, suggesting favorable market access and cost management strategies.

Elanco's Credelio Quattro gains FDA approval as the broadest canine oral parasiticide, targeting six parasite types in a single monthly dose.