OBJECTIVES: Dry eye disease (DED) is a multifactorial condition for which topical anti-inflammatory and immunomodulatory drugs (eg, cyclosporine) are used to treat associated ocular surface inflammation and improve DED signs and symptoms. We assessed efficacy and patient-reported outcomes associated with cyclosporine ophthalmic solution 0.09% (CsA 0.09%), a nanomicellar formulation designed to improve ocular delivery of CsA, in patients with DED that was inadequately controlled on cyclosporine ophthalmic emulsion 0.05% (CsA 0.05%).

METHODS: This Phase 4 study enrolled adults with DED that was inadequately controlled (still symptomatic and/or exhibiting disease signs) on current CsA 0.05% therapy for ≥3 months. All patients received CsA 0.09% (1 drop per eye twice daily) for 12 weeks. Efficacy assessments included central corneal fluorescein staining (CFS), Schirmer’s test, modified Symptom Assessment iN Dry Eye (mSANDE) questionnaire, and frequency of artificial tear (AT) use at Weeks 4, 8, and 12, as well as treatment preference at Week 12. Safety assessments included adverse event (AE) reporting at each visit.

RESULTS: Most patients in the intent-to-treat population (n = 124) were female (87.9%) and the mean (standard deviation [SD]) age was 65.6 (11.5) years. Mean (SD) changes from baseline were statistically significant for central CFS score (−0.5 [0.9]; P <0.0001), Schirmer’s test score (2.4 [8.6]; P <0.01), mSANDE score (−29.5 [26.4]; P <0.0001), and frequency of AT use (−1.5 [2.4]; P <0.0001) at Week 12 of CsA 0.09% treatment. Also, at Week 12, 86 (69.4%) patients preferred the current treatment with CsA 0.09% over previous CsA 0.05% therapy. Overall, 58 (43.3%) patients reported ≥1 treatment-emergent AE and most AEs were mild in severity (73.8%).

CONCLUSIONS: Twice-daily CsA 0.09% was the preferred treatment by most patients and resulted in significant improvements in the signs and symptoms of DED at Week 12 in patients whose disease was inadequately controlled on CsA 0.05%.