By Fineline Cube 
Japan‑based Santen Pharmaceutical Co., Ltd. (TYO: 4536) announced the commercial launch of Tapcom (tafluprost/timolol maleate) in China, marking the first prescription ophthalmic combination in the country that contains a first‑line prostaglandin analog without preservatives.
Regulatory Milestone
- NMPA Approval – The National Medical Products Administration granted approval in March 2025 for Tapcom to lower intra‑ocular pressure (IOP) in patients with open‑angle glaucoma or ocular hypertension who exhibit inadequate response to monotherapy (beta‑blocker or prostaglandin analog) or who require preservative‑free therapy.
- First‑In‑Class – Tapcom is the inaugural preservative‑free combination available in China, meeting a critical unmet need for chronic glaucoma patients.
Product Profile
| Feature | Details |
|---|---|
| Active Ingredients | Tafluprost (PG analog) + Timolol Maleate (beta‑blocker) |
| Dosage Form | Eye drop, once daily |
| Preservative‑Free | Eliminates benzalkonium chloride and other common preservatives |
| Indications | Open‑angle glaucoma, ocular hypertension requiring combination therapy |
Clinical Impact
- Efficacy & Safety – Clinical data demonstrate that Tapcom achieves IOP‑lowering efficacy comparable to using two separate drops, with a safety profile consistent with its individual components.
- Patient Convenience – Once‑daily dosing and the elimination of a second drop reduce treatment burden, improving adherence and overall quality of life.
- Long‑Term Benefits – Reducing preservative exposure mitigates ocular surface disease and preserves corneal health in patients on lifelong therapy.
Market Outlook
- Growing Demand – China’s aging population and rising prevalence of glaucoma create a sizable addressable market for preservative‑free combination therapies.
- Competitive Advantage – Tapcom’s unique positioning as the first preservative‑free PG analog/beta‑blocker combo differentiates it from existing monotherapies and multi‑drop regimens.
- Strategic Expansion – Santen plans to leverage its global distribution network to scale Tapcom across key Chinese regions, targeting both ophthalmology clinics and specialty pharmacies.-Fineline Info & Tech