Santen receives marketing authorization application approval from NMPA of China for tafluprost/timolol maleate (Tapcom) in patients with open-angle glaucoma

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Santen Pharmaceutical has received approval of its marketing authorization application from the National Medical Products Administration (NMPA) of China for tafluprost/timolol maleate (Tapcom) for lowering intraocular pressure (IOP) of patients with open-angle glaucoma or ocular hypertension.

Tapcom is a preservative-free, fixed-combination eye drop of tafluprost 0.0015% and timolol 0.5%. According to the company, Tapcom will be the first preservative-free ophthalmic combination formulation in China containing a first-line prostaglandin derivative.

The two active ingredients have different mechanisms of action on aqueous humor dynamics to lower the IOP. Tafluprost is a prostanoid FP receptor agonist and promotes aqueous humor outflow, while timolol maleate is a nonselective β-receptor blocker and reduces aqueous humor production.

Peter Sallstig, chief medical officer of Santen Pharmaceutical, commented on the approval in a press release from the company.

"Glaucoma remains the leading cause of irreversible blindness worldwide, deeply impacting the quality of life of many patients. Therefore, Santen has prioritized glaucoma as a key therapeutic focus, dedicating ourselves to the development of treatments that meets patients’ needs and the delivery of high-quality ophthalmic drugs. The approval of Tapcom in China represents a significant milestone, offering new treatment options for Chinese glaucoma patients and advancing the field of glaucoma care,” said Sallstig.

References:

1. Santen announces China NMPA approval of Tapcom in patients with open-angle glaucoma or ocular hypertension. Santen. Published April 4, 2025. Accessed April 7, 2025. https://www.santen.com/en/news/2025/2025_1/20250404