Water-free cyclosporine formulation safe, effective for dry eye disease
Treatment with water-free cyclosporine formulation (CyclASol) at either 0.1% or 0.05% concentration is tolerable and provides effective relief of the signs of dry eye disease (DED), according to data from a phase II study.
The study randomly assigned 207 DED patients (mean age, 62.4 years; 73.9 percent female) to one of the following treatment arms: CyclASol 0.05% (n=51), CyclASol 0.1% (n=51), vehicle (n=52) and cyclosporine emulsion (n=53). Dosed twice daily, the 16-week treatment was initiated after a 2-week run-in period.
Efficacy endpoints included total and subregion corneal fluorescein staining, conjunctival staining, visual analogue scale (VAS) for dry eye symptoms, VAS severity, and Ocular Surface Disease Index (OSDI) questionnaire scores.
During the 16-week treatment period, CyclASol consistently reduced corneal and conjunctival staining compared with both the vehicle and emulsion. The onset of effect occurred early at day 14.
In mixed-effects model–based approach, the effect of CyclASol was statistically significant compared with that of the vehicle (total corneal staining, p<0.1; central corneal staining, p<0.001; conjunctival staining, p<0.01). CyclASol also demonstrated a significant effect on OSDI as symptom parameter (p<0.01).
Dryness symptoms, as measured by VAS, improved across all treatment arms, with no significant difference between CyclASol and vehicle.
In terms of safety, the rate of ocular adverse events was low in all treatment arms. Treatment-emergent adverse events were reported in 65 patients (31.4 percent) overall, all of which were mild-to-moderate in severity.
The present data show that the new water-free cyclosporine formulation relieves the signs of DED as early as after 2 weeks of treatment, with excellent safety, tolerability and comfort profile, according to researchers.