Santen Pharmaceutical has received approval from China’s National Medical Products Administration (NMPA) for its Marketing Authorisation Application for Tapcom, a preservative-free, fixed-combination eye drop.

参天制药公司已获得中国国家药品监督管理局（NMPA）对其无防腐剂、固定组合滴眼液Tapcom的上市许可申请的批准。

Glaucoma is a leading cause of irreversible blindness worldwide, with damage to the optic nerve resulting in progressive vision loss. Controlling IOP is a key approach to managing the disease and preventing further damage.

青光眼是全球不可逆失明的主要原因之一，视神经受损会导致进行性视力丧失。控制眼压是管理该疾病和防止进一步损害的关键方法。

By 2040, the global number of glaucoma cases is expected to reach 111.8 million. According to the 2022 Chinese Glaucoma Guidelines, combination therapies may be recommended when monotherapy does not provide sufficient pressure control. Fixed-combination treatments are considered more convenient and can improve patient adherence, making them a cost-effective choice compared to using separate medications..

到 2040 年，全球青光眼病例预计将达 1.118 亿。根据《中国青光眼指南（2022）》，当单一疗法无法提供足够的压力控制时，可推荐联合疗法。复方固定组合治疗被认为更方便，能够提高患者的依从性，与单独使用多种药物相比，是一种更具成本效益的选择。

Tapcom is already approved in more than 40 countries and regions, including Europe and Asia. Its introduction in China expands access to an alternative glaucoma treatment that aligns with international clinical recommendations.

Tapcom已经在包括欧洲和亚洲在内的40多个国家和地区获得批准。它在中国的引入扩大了符合国际临床建议的青光眼替代治疗的可及性。

The formulation combines tafluprost 0.0015%, co-developed with AGC Inc., and timolol maleate 0.5%, offering an additional treatment option for patients with open-angle glaucoma or ocular hypertension. It is intended for individuals who have not achieved target intraocular pressure (IOP) with topical beta-blockers or prostaglandin derivatives alone, as well as those who may benefit from preservative-free eye drops during long-term use..

该配方结合了与AGC公司共同开发的0.0015%的他氟前列素和0.5%的马来酸噻吗洛尔，为开角型青光眼或高眼压症患者提供了额外的治疗选择。它适用于单独使用局部β-受体阻滞剂或前列腺素衍生物未能达到目标眼内压（IOP）的患者，以及那些在长期使用中可能受益于无防腐剂滴眼液的人群。

Long-term use of preserved glaucoma eye drops has been associated with ocular surface damage. Tapcom is the first preservative-free fixed-combination ophthalmic treatment in China that contains a first-line prostaglandin derivative.

长期使用含防腐剂的青光眼滴眼液会损害眼部表面。Tapcom是中国首个不含防腐剂的固定组合眼科治疗方法，其中包含一线前列腺素衍生物。

The two active ingredients work through different mechanisms: tafluprost acid, a prostanoid FP receptor agonist, increases the outflow of aqueous humour, while timolol maleate, a nonselective beta-blocker, reduces aqueous humour production.

两种活性成分通过不同的机制发挥作用：氟前列素酸，一种前列腺素FP受体激动剂，增加房水流出，而马来酸噻吗洛尔，一种非选择性β-受体阻滞剂，减少房水产生。

The once-daily formulation provides the same efficacy and safety as the separate use of both components, improving patient convenience, treatment adherence, and overall quality of life while minimising exposure to preservatives.

每日一次的制剂与分别使用两种成分具有相同的疗效和安全性，提高了患者的便利性、治疗依从性和整体生活质量，同时将防腐剂的暴露降至最低。