At the ASCRS 2025 annual meeting on Saturday, April 26, Michelle M. Hessen, OD, of the Wilmer Eye Institute presented a poster summarizing her recent study, “Cyclosporine solution 0.09% in patients with dry eye uncontrolled on cyclosporine emulsion 0.05%: a subgroup analysis.”
During this phase 4, single-arm, multicenter study, patients with uncontrolled dry eye who had been on cyclosporine 0.05% for 3 months or longer were started on cyclosporine 0.09% dosed twice daily for 12 weeks. The data were evaluated at baseline and at weeks 4, 8, and 12, with primary endpoints being mean change from baseline of the total corneal fluorescein staining and the modified Symptom Assessment in Dry Eye (mSANDE) scores. This secondary subgroup was evaluated for change in corneal fluorescein staining and change in conjunctival lissamine green staining in patients with and without meibomian gland dysfunction.
We spoke to Dr. Hessen about her findings:
OM: What key differences did you observe in treatment response between patients using cyclosporine solution 0.09% compared to those who were previously on cyclosporine emulsion 0.05%?
MH: In patients using cyclosporine 0.09% twice daily, previously uncontrolled with cyclosporine 0.05% for ≥ 3 months, there was a statistically significant decrease in total corneal fluorescein staining and mSANDE scores at weeks 4, 8, and 12 irrespective of age and sex.
OM: Given the significant improvements seen across age and sex subgroups, how should these findings influence clinical decision-making for ophthalmologists treating patients with dry eye disease who are inadequately controlled on CsA 0.05%?
MH: Given the data, ophthalmologists should consider switching those patients with inadequately controlled dry eye, [despite being] treated with cyclosporine 0.05%, to cyclosporine 0.09% twice daily.
OM: Were there any unexpected findings in the study, particularly regarding differences in efficacy or safety outcomes between male and female patients or across different age groups?
MH: While it was expected that cyclosporine 0.09% would be safe and generally well tolerated, I was pleasantly surprised to learn that there was statistically significant improvement in total corneal fluorescein staining and symptoms, regardless of age or sex, as early as 4 weeks.
OM: Thank you for your time, Dr. Hessen.