Dry eye disease is a multifactorial ocular surface illness characterized by a lack of tear film equilibrium and accompanied by ocular symptoms. DED is caused by tear film instability and hyperosmolarity, ocular surface inflammation and injury, and neurosensory abnormalities. Cyclosporine A (CsA) is a selective immunomodulator that reduces T-cell activation and T-lymphocyte infiltration of the lacrimal glands, inhibits ocular surface epithelial cell death, and is useful in the treatment of DED. This study was carried out by Wenyan Peng and colleagues in order to confirm the effectiveness and safety of a new ophthalmic CyclAGel, 0.05% in treating patients with moderate-to-severe dry eye conditions.
The COSMO study was a multicenter, randomized, double-masked, vehicle-controlled phase III experiment. Between November 2020 and April 2021, patients with moderate-to-severe DED were enrolled at 37 hospitals in China. Eligible participants were randomly assigned to receive either CyclAGel 0.05% or vehicle eye drops once a night (QD). The primary endpoint was the proportion of patients who improved by at least one point on the ICSS at day 84. TEAEs (treatment-emergent adverse events) were documented.
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
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