Santen Secures NMPA Approval for Tapcom to Treat Open-Angle Glaucoma and Ocular Hypertension in China
Friday, April 04, 2025
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.
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.
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.
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.
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.
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.
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.
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.
Source: santen.com
