Promising results for CyclAGel in treating moderate-to-severe dry eye disease
The clinical trial for CyclAGel, a 0.05% cyclosporine A gel, in the treatment of moderate-to-severe dry eye disease (DED) has shown promising results, according to results presented at AAO 2023.
The study demonstrated significant improvements in dry eye symptoms, corneal staining scores, and tear production in patients treated with CyclAGel compared to those who received a placebo.
In the study, 644 patients were randomly assigned in a 1:1 ratio to receive either CyclAGel 0.05% or a vehicle (placebo) once nightly for 12 weeks. Dry eye symptoms, inferior corneal staining score (ICSS), Oxford scale score of corneal and conjunctival staining, and Schirmer II test results were assessed at Days 0, 14, 42, and 84.
The results demonstrated significant improvements in the CyclAGel group compared to the vehicle group. The proportions of subjects with at least a 1-point and 2-point improvement in ICSS, as well as an improvement in the Oxford scale, were notably higher at Days 14, 42, and 84 in the CyclAGel group (all P ≤ 0.005). In addition, the Schirmer II test showed a significant increase in tear production in the CyclAGel group compared to the vehicle group at Days 14 and 84 (all P < 0.05).
The study found that CyclAGel 0.05% was well-tolerated, with treatment-emergent adverse events mostly reported as mild.
Majmudar PA, et al. Cyclosporine A (0.05%) Ophthalmic Gel in the Treatment of DED: A Multicenter, Randomized, Double-Masked, Phase 3 Study. Presented at: AAO 2023.