Santen’s Tapcom Receives NMPA Approval in China for Open-Angle Glaucoma and Ocular Hypertension

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

Tapcom: A Preservative-Free Fixed Combination Therapy

Tapcom is a preservative-free, fixed-combination ophthalmic solution that combines:

       • Tafluprost 0.0015%, a prostanoid FP receptor agonist that enhances aqueous humor outflow

       • Timolol maleate 0.5%, a nonselective β-receptor blocker that reduces aqueous humor production

The two agents act through complementary mechanisms, resulting in effective intraocular pressure (IOP) reduction in patients with open-angle glaucoma or ocular hypertension.

According to Santen Pharmaceutical, Tapcom will be the first preservative-free ophthalmic combination in China that includes a first-line prostaglandin derivative.

Santen Comments on Tapcom Approval and Glaucoma Treatment Efforts

Peter Sallstig, Chief Medical Officer of Santen Pharmaceutical, commented on the regulatory milestone in the company’s press release:

“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 meet 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.”