A novel cyclosporine ophthalmic gel demonstrated high efficacy, safety, tolerability, and comfort in treating moderate to severe dry eye disease, according to research published in Clinical Therapeutics.

To confirm preclinical safety, efficacy, and tolerability data, researchers conducted a multicenter, randomized, positive-controlled, single-blind, phase 2 study of 2 strengths of the solution (0.05% and 0.1%) administered once or twice daily. 

Participants (n=240; average age, 47.98 years ± 13.33 years; 77.2% women) with moderate to severe dry eye disease were randomly assigned to 1 of 4 treatment groups. The first group was issued the novel cyclosporine gel at a strength of 0.05% twice daily, the second group was given that dose once daily, the third received 0.1% once daily, and the fourth group was treated with a different cyclosporine drop  0.05% twice daily. No significant differences in baseline characteristics were noted across the groups. Data were analyzed using both a full analysis set and a per-protocol set. 

At 12 weeks, all treatment groups demonstrated improvement in symptoms of dry eye, measured via visual analog scale. Consistent and statistically significant decreases in total eye dryness scores were noted at the end of the treatment period in both the full analysis and per-protocol groups (P <.05). Additionally, all 3 gel groups had better effect tendency compared with the drop group. 


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Secondary outcomes — including symptoms of dryness like burning, stinging, itching, foreign body sensation, discomfort, light sensitivity, and pain, and CFS, BUT, and Schirmer’s test scores — had no statistically significant between-group differences. 

Overall, 137 patients reported 277 treatment-emergent adverse events of mild or moderate intensity. Drug-related treatment-emergent adverse events took place in 20 occurances in 14 patients in the 0.05% once-daily group, 25 occurrences in 17 patients in the 0.05% twice-daily group, 24 occurrences in 15 patients in the 0.1% once daily, group, and 19 occurrences in 16 patients in the drop group. Five patients withdrew from the study due to 6 treatment-emergent adverse event occurrences. 

No significant differences were noted between the cyclosporine drop and the new gel, marketed as Cyclagel. 

Study limitations were the open-label nature of the comparator group, due to differences in drop behavior and packaging, and potential bias in patient reporting. 

“Both Cyclagel concentrations and frequencies exhibited excellent safety, tolerability, and comfort profiles,” the research demonstrates. “Cyclagel 0.05% [once daily] was…selected as the study drug for a clinical phase 3 trial to further expand the sample size and verify the efficacy and safety in the treatment of patients with moderate to severe dry eye disease.”

Reference

Peng W-Y, Chen R-X, Dai H, et al. Efficacy, safety, and tolerability of a novel cyclosporine, a formulation for dry eye disease: A multicenter phase II clinical study. Published online February 2, 2021. Clin Ther. doi:10.1016/j.clinthera.2020.12.023