Water-Free Cyclosporine Solution may Improve Dry Eye Disease symptoms: JAMA

A recent study published in the recent edition of Journal of American Medical Association revealed promising results in the treatment of Dry Eye Disease (DED). This study focused was set out to evaluate the efficacy and safety of a water-free cyclosporine ophthalmic solution in Chinese participants with moderate to severe DED.

The multicenter, double-blind, vehicle-controlled, phase 3 randomized clinical trial was conducted from March 4, 2021 to July 22, 2022 and enrolled a total of 206 adult participants from 12 hospitals in China. The participants were randomly assigned to receive either the water-free cyclosporine solution or a vehicle control. After a 29-day treatment period, the results were analyzed.

The primary endpoints of the study were changes in total corneal fluorescein staining (tCFS) and dryness score on a visual analog scale (VAS) at day 29. The findings revealed a marked improvement in tCFS in the cyclosporine group when compared to the vehicle group by demonstrating the superiority of the treatment. However, the dryness score on the VAS did not show notable improvement between the two groups at day 29.

The study also evaluated the safety profile of the treatment. During the 29-day treatment period, treatment-related adverse events were reported in a small percentage of participants in both the cyclosporine and vehicle groups that indicates an acceptable safety profile for the water-free cyclosporine solution. Overall, the development of a water-free cyclosporine ophthalmic solution presents a potential solution to the challenges posed by the hydrophobic nature of traditional cyclosporine formulations in delivering effective treatment to the ocular surface.

Reference:

Peng, R., Jie, Y., Long, Q., Gong, L., Zhu, L., Zhong, X., Zhao, S., Yan, X., Gu, H., Wu, H., Li, G., Zhang, K., Krösser, S., Xu, R., & Hong, J. (2024). Water-Free Cyclosporine Ophthalmic Solution vs Vehicle for Dry Eye Disease. In JAMA Ophthalmology. American Medical Association (AMA). https://doi.org/10.1001/jamaophthalmol.2024.0101