Liu Zhaochuan, Lin Haotian, Huang Chulong, Chen Wan, Xiang Wu, Geng Yu, Chen Weirong
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou 510060, China.
Sci Rep. 2015 Nov 12;5:16468. doi: 10.1038/srep16468.
Fingolimod (FTY720), a novel class of sphingosine 1-phosphate receptor modulators, has received special interest among ophthalmologists, particularly given that oral administration of FTY720 has proven to effectively treat corneal graft rejection in animal models. However, no studies have examined the performance of FTY720 as an ophthalmic solution in reducing corneal rejection in high-risk corneal rejection models, and the stability and ocular irritation profile of FTY720 ophthalmic solution are also unknown. Thus, we developed 0.1%, 0.2% and 0.5% FTY720 ophthalmic solutions and evaluated their chemical stabilities under various storage conditions with high- performance liquid chromatography. To investigate the ocular irritancy of the FTY720 ophthalmic solution, New Zealand albino rabbits were subjected to the Draize test. Furthermore, classic, well-established rat allogenic penetrating keratoplasty models were used to investigate the anti-rejection efficacy of the tested FTY720 ophthalmic solutions. We found that the non-irritating 0.5% FTY720 ophthalmic solution could prolong corneal allograft survival in rats with significant efficacy for about one month. Furthermore, no significant concentration changes occurred in any of the types of FTY720 ophthalmic solutions within three months. These results revealed crucial profiles of FTY720 ophthalmic solutions and warrant further investigation and optimization of FTY720 in the anti-rejection therapy after keratoplasty.
芬戈莫德(FTY720)是一类新型的1-磷酸鞘氨醇受体调节剂,受到了眼科医生的特别关注,尤其是口服FTY720已被证明能有效治疗动物模型中的角膜移植排斥反应。然而,尚无研究考察FTY720眼药水在高危角膜排斥模型中减少角膜排斥反应的效果,且FTY720眼药水的稳定性和眼部刺激性也未知。因此,我们研发了0.1%、0.2%和0.5%的FTY720眼药水,并采用高效液相色谱法评估了它们在不同储存条件下的化学稳定性。为了研究FTY720眼药水的眼部刺激性,我们对新西兰白化兔进行了Draize试验。此外,我们还使用经典的、成熟的大鼠同种异体穿透性角膜移植模型来研究受试FTY720眼药水的抗排斥效果。我们发现,无刺激性的0.5% FTY720眼药水可延长大鼠角膜移植的存活时间,具有显著疗效,约为1个月。此外,在三个月内,任何类型的FTY720眼药水的浓度均未发生显著变化。这些结果揭示了FTY720眼药水的关键特性,值得在角膜移植术后的抗排斥治疗中对FTY720进行进一步研究和优化。