Cyclosporine Solution 0.09% Boosts Outcomes in Uncontrolled Dry Eye

A subgroup analysis of a Phase 4, open-label, single-arm, multicenter study demonstrated the benefit of cyclosporine (CsA) ophthalmic solution 0.09% (CEQUA) for patients with dry eye disease (DED) uncontrolled on CsA ophthalmic emulsion 0.05% (Restasis).

Presented at the 2025 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting, these data showed CsA 0.09% led to a statistical improvement in corneal fluorescein staining (CFS) and modified Symptom Assessment in Dry Eye (mSANDE) scores from Weeks 4 to 12, irrespective of age or gender.

“Males showed more robust improvement in mSANDE scores than females; statistical comparisons between subgroups were not performed,” wrote the investigative team, led by Richard Adler, MD, director of ophthalmology at Azman Eye Care Specialists. “CsA 0.09% was generally well tolerated, with more reported adverse events of mild severity.”

Characterized by the loss of tear film homeostasis, hyperosmolarity, and tear film instability, DED perpetuates ocular surface inflammation and damage, particularly in females and older individuals. The US Food and Drug Administration (FDA) approved the anti-inflammatory agents, CsA 0.09% and CsA 0.5%, to increase tear production in individuals with DED.

This study evaluated the age- and sex-associated differences for the efficacy of CsA 0.09% in patients with DED still symptomatic or exhibiting signs of disease on current CsA 0.05% treatment for more than 3 months. Key inclusion criteria included a total CFS score ≥6 (range, 0-20) or ≥2 in an individual zone (range, 0–4) in 1 eye and a mSANDE global symptom score ≥40 (range, 0-100).

Enrolled individuals applied a single drop of CsA 0.09% per eye twice daily over 12 weeks. Adler and colleagues assessed CFS and mSANDE questionnaire scores at baseline and Weeks 4, 8, and 12, or those who discontinued the study early—safety analysis included monitoring for and reporting adverse events at each study visit. An age- and sex-based subgroup analysis was performed for each efficacy and safety outcome.

Overall, the study enrolled 124 patients, including 109 females, with a median age of 68 years. Most patients were White (88%) and not Hispanic or Latino (86%). At baseline, the mean total CFS scores were 6.8 and 4.7 for those above and below the median age, respectively. The respective scores were 4.2 and 5.9 for males and females.

The mean baseline mSANDE scores were 63.2 and 70.5 for those above and below the median age, respectively, and 75.8 and 65.9 for males and females, respectively. The analysis found the mean changes from baseline in CFS and mSANDE scores significant at Weeks 4, 8, and 12, irrespective of age (P <.0001) and sex (P ≤.0473).

“Twice-daily CsA 0.09% demonstrated significant improvement from baseline in total CFS and mSANDE scores at Weeks 4, 8, and 12 of treatment in patients with DED inadequately controlled on CsA 0.0%, regardless of age or sex,” Adler and colleagues wrote.

References

Adler R, Johnston K, Hessen M, Nichols KK et al. Cyclosporine Solution 0.09% in Patients with Dry Eye Uncontrolled on Cyclosporine Emulsion 0.05%: A Subgroup Analysis. Poster presented at the 2025 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. April 25-28, 2025. Los Angeles, CA.