Safety profile of 0.0015% tafluprost eye drops in China: a post-marketing observational study
Authors:   Department of Ophthalmology, Eye &amp; ENT Hospital of Fudan University, Shanghai 200000, China, Chen Xue-Li , Qu Bo ,   Department of Ophthalmology, the Fourth Affiliated Hospital of China Medical University, Shenyang 110000, Liaoning Province, China, Wang Ye-Wei ,   Department of Ophthalmology, Da Lian He Eye Specialist Hospital, Dalian 116000, Liaoning Province, China, Tang Xin ,   Department of Ophthalmology, Beijing Tongren Hospital, Beijing 100000, China, Wang Yu-Hong ,   Department of Ophthalmology, Xiamen Eye Center of Xiamen University, Xiamen 361000, Fujian Province, China, Zhou Guo-Yi ,   Department of Ophthalmology, Yueqing People&#x2019;s Hospital, Wenzhou 325600, Zhejiang Province, China, Lin Ming-Kai ,   Department of Glaucoma, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510000, Guangdong Province, China, Shen Jing-Yuan ,   Department of Ophthalmology, Shengzhou Shen&#x2019;s Eye Hospital, Shaoxing 312400, Zhejiang Province, China, Yao Jin ,   Department of Ophthalmology, the Affiliated Eye Hospital of Nanjing Medical University, Nanjing 210000, Jiangsu Province, China, Li Su-Yan ,   Department of Ophthalmology, Xuzhou No.1 Peoples Hospital, Xuzhou 221000, Jiangsu Province, China, Wu Miao-Qin ,   Department of Ophthalmology, Zhejiang Provincial People&#x2019;s Hospital, Hangzhou 310000, Zhejiang Province, China, Peng Hua-Zong ,   Department of Ophthalmology, Wuhan Eyegood Ophthalmic Hospital, Wuhan 430014, Hubei Province, China, Lai Ming-Ying ,   Department of Ophthalmology, Shenzhen Eye Hospital, Shenzhen 518001, Guangdong Province, China, Wu Ren-Yi ,   Department of Glaucoma, Shanghai Heping Eye Hospital, Shanghai 200000, China, Zhang Yi-Nong ,   Department of Ophthalmology, Wuxi Second People&#x2019;s Hospital, Wuxi 214000, Jiangsu Province, China, Li Yan ,   Department of Ophthalmology, First Affiliated Hospital of Kunming Medical University, Kunming 650000, Yunnan Province, China, Wu Xiao-Jun ,   Department of Ophthalmology, Union Shenzhen Hospital (Nanshan Hospital), Shenzhen 518000, Guangdong Province, China, Zhang Ming-Chang ,   Department of Ophthalmology, Wuhan Union Hospital, Wuhan 430000, Hubei Province, China, Guo Su-Ping ,   Department of Ophthalmology, Shengyang He Eye Specialist Hospital, Shenyang 110000, Liaoning Province, China, Sun Xing-Huai ,   Department of Ophthalmology, Eye &amp; ENT Hospital of Fudan University, Shanghai 200000, China
Published: December 2022

AIM: To investigate the treatment pattern and safety of tafluprost for glaucoma and ocular hypertension (OH) in clinical practice in China.
METHODS: This post-marketing observational study included patients who received tafluprost to lower intraocular pressure (IOP) within 30d between September 2017 and March 2020 in 20 hospitals in China. Adverse drug reactions (ADRs) during tafluprost treatment and within 30d after the treatment were collected.
RESULTS: A total of 2544 patients were included in this study, of them 58.5% (1488/2544) had primary open angle glaucoma (POAG), 21.9% (556/2544) had OH and 19.7% (500/2544) used tafluprost for other reasons. Of 359 ADRs occurred in 10.1% (258/2544) patients, and no serious adverse event occurred. The most common ADR was conjunctival hyperemia (128 ADRs in 124 patients, 4.9%). Totally 1670 participants (65.6%) combined tafluprost with carbonic anhydrase inhibitors (CAIs; 37.1%, 620/1670), sympathomimetics (33.5%, 559/1670), β-blockers (33.2%, 555/1670), other prostaglandin analogs (PGAs; 15.6%, 260/1670) and other eye drops (15.1%, 253/1670). The highest incidence of conjunctival hyperemia was noted in patients who received tafluprost in combination with other PGAs (23 ADRs in 23 patients, 8.8%, 23/260) and the lowest was in combination with CAIs (16 ADRs in 16 patients, 2.6%, 16/620). Tafluprost was applied in primary angle-closure glaucoma (41.6%, 208/500), after glaucoma surgery (17.8%, 89/500) and after non-glaucoma surgery (15.8%, 79/500).
CONCLUSION: Tafluprost is safe for POAG and OH, and tolerable when combined with other eye drops and under various clinical circumstances.