Study finds cyclosporine A gel effective against dry eye disease

The key findings of this study were:

1. The CyclAGel and vehicle groups each had 315 and 312 individuals in the full analysis set (FAS). The main efficacy endpoint was met.

2. The proportion of participants having at least a 1-point improvement in ICSS from baseline to day 84 in the CyclAGel group was substantially greater than in the vehicle group.

3. Significant improvements in the ICSS and Oxford scale grading of corneal and conjunctival fluorescein staining were also found at days 14, 42, and 84 when compared to the vehicle.

4. On days 14 and 84, the Schirmer tear test findings were considerably greater in the CyclAGel group than in the vehicle group.

5. The TEAEs were largely modest, and the CyclAGel 0.05% was well tolerated. Eye discomfort was the most common treatment-related TEAE.

In conclusion, in moderate-to-severe DED, CyclAGel 0.05% QD significantly decreased corneal and conjunctival staining and enhanced tear secretion compared to the control group. It also greatly reduced the symptoms. CyclAGel 0.05% QD is a new effective, safe, and well-tolerated therapy alternative for moderate-to-severe DED that may provide additional benefits of convenience and compliance as a once-a-day treatment.

Reference: 

Peng, W., Jiang, X., Zhu, L., Li, X., Zhou, Q., Jie, Y., You, Z., Wu, M., Jin, X., Li, X., & Zhou, S. (2022). Cyclosporine A (0.05%) Ophthalmic Gel in the Treatment of Dry Eye Disease: A Multicenter, Randomized, Double-Masked, Phase III, COSMO Trial. In Drug Design, Development and Therapy: Vol. Volume 16 (pp. 3183–3194). Informa UK Limited. https://doi.org/10.2147/dddt.s370559