Santen Announces China NMPA Approval of Tapcom^🄬 in Patients with Open-Angle Glaucoma or Ocular Hypertension

April 4, 2025 Osaka, Japan – Santen Pharmaceutical Co., Ltd. (hereinafter Santen) announced that the National Medical Products Administration (NMPA) of China, has approved the Marketing Authorization Application for Tapcom^🄬 (generic name: tafluprost/timolol maleate, development code: STN1011101, a preservative-free, fixed-combination eye drop of tafluprost 0.0015% (co-developed by Santen and AGC Inc. (head office: Chiyoda District, Tokyo)) and timolol 0.5%. Tapcom^🄬 is for lowering intraocular pressure (IOP) of patients with open-angle glaucoma or ocular hypertension, offering new treatment options to patients for whom topical beta-blockers or prostaglandin derivatives monotherapies failed to achieve target IOP, and to patients who may benefit from preservative-free eye drops during long-term topical use of glaucoma medication.

Glaucoma causes damage to the optic nerve, leading to visual field loss, and it remains the leading cause of irreversible blindness worldwide.^1,2 Since the disease is generally progressive and irreversible, early detection and treatment to control the progression are crucial, and lowering intraocular pressure is an effective means of avoiding damage to the optic nerve. The number of people living with glaucoma worldwide is expected to reach an estimated 111.8 million in 2040.³ The “Chinese Glaucoma Guidelines 2022” states that when monotherapy fails to achieve the target IOP, a combination of drugs with different mechanisms of action may be used. A fixed combination is more convenient to use and has better compliance, making it a more economical therapy. In comparison with the separate use of both components, a fixed combination is recommended when available. ⁴

In addition, long-term topical use of glaucoma medication containing preservatives could cause and/or aggravate existing Ocular Surface Disease. Among the existing glaucoma treatments in China, 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. The active metabolite of tafluprost (tafluprost acid), an ingredient in this formulation, is a prostanoid FP receptor agonist and promotes aqueous humor outflow, while the other ingredient, timolol maleate, is a nonselective β-receptor blocker and reduces aqueous humor production. The same efficacy and safety as the combination therapy can be achieved with once-daily administration, further improving convenience, compliance and quality of life of patients compared with the concomitant use of two eye drops. Reducing preservative exposure at the same time can increase the benefits for glaucoma patients taking long-term medications.

Santen Chief Medical Officer Peter Sallstig commented: "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."

Tapcom^🄬 has been approved in more than 40 countries and regions worldwide, including Europe and Asia.

References

1. Flaxman S et al. The Lancet Global Health (2017) 5: e1221–34
2. Steinmetz JD et al. The Lancet Global Health (2020) 9: e144-60
3. Tham Y-C et al. Ophthalmology. 2014:121(11):2081-2090.
4. Glaucoma Group, etc, Ophthalmology Branch, Chinese Medical Association. Chinese Glaucoma Guidelines [M].Buclas.布克.2022.

About Santen
As a specialized company dedicated to eye health, Santen aspires to contribute to the realization of “Happiness with Vision” by providing products and services to patients, consumers, and medical professionals around the world. Since its establishment, and guided by its CORE PRINCIPLE, “Tenki ni sanyo suru,” Santen has been committed to helping people maintain and improve their eye health for more than 130 years. Santen is engaged in the global research and development, manufacturing, and sales and marketing of pharmaceutical products in the field of eye care, supporting the eye health of approximately 50 million people in more than 60 countries and regions worldwide. Santen’s mission is to provide essential and significant value to patients and society in the prevention, diagnosis, and treatment of eye diseases through products and services created from its expertise in the ophthalmology field and from the patient's perspective. To create a future in which as many patients as possible can lead happy and fulfilling lives, Santen is committed to doing its utmost to realize a society in which people around the world can experience “Happiness with Vision.”
For more information, please visit Santen’s website https://www.santen.com/en.

Contact
Corporate Communications
Santen Pharmaceutical Co., Ltd.
E-mail: communication@santen.com