Topical Cyclosporine A cationic ophthalmic emulsion effective treatment option for vernal keratoconjunctivitis in kids

Cyclosporine A cationic ophthalmic emulsion (CsA CE) was evaluated in paediatric and adolescent patients with vernal keratoconjunctivitis (VKC) in the NOVATIVE (NCT00328653) and VEKTIS (NCT01751126) trials. The similarity of these studies permitted pooled assessment of the effect of Cyclosporine A cationic ophthalmic emulsion on corneal damage as well as safety and tolerability.

Subjects/Methods

Pooled outcomes were assessed for the first 28 days of treatment. In NOVATIVE, 118 patients were randomised to 4 times daily (QID) Cyclosporine A cationic ophthalmic emulsion 0.05%, 0.1%, or vehicle eye drops. In VEKTIS, 169 patients were randomised to Cyclosporine A cationic ophthalmic emulsion 0.1% QID or twice daily (BID) or vehicle. For these analyses, treatment groups comprised: (1) pooled CsA CE 0.1% QID arms (high-dose; n = 96); (2) pooled CsA CE 0.05% QID arm from NOVATIVE and Cyclosporine A cationic ophthalmic emulsion 0.1% BID data from VEKTIS (low-dose; n = 93); and (3) pooled vehicle QID arms (vehicle; n = 98).

Results

Changes from baseline to day 28 (mean ± standard deviation) in corneal fluorescein staining (CFS) scores for Cyclosporine A cationic ophthalmic emulsion high-dose, low-dose, and vehicle groups were −1.6 ± 1.47 (95% CI: −0.9, −0.1; p = 0.0124 vs vehicle), −1.7 ± 1.39 (95% CI: −1.1, −0.3; p = 0.0015 vs vehicle), and −1.0 ± 1.55, respectively. Adverse events (AEs) of any type were reported in 37.5%, 34.4%, and 37.8% of the high-dose, low-dose, and vehicle groups, respectively. Most were mild or moderate in severity.

Cyclosporine A cationic ophthalmic emulsion significantly decreased corneal damage and was safe and well tolerated in patients with VKC. These data support Cyclosporine A cationic ophthalmic emulsion as a treatment option for the management of VKC.

Reference:

Leonardi, A., Doan, S., Aragona, P. et al. Topical cyclosporine A cationic ophthalmic emulsion in paediatric vernal keratoconjunctivitis: pooled analysis of randomised NOVATIVE and VEKTIS trials. Eye 37, 2320–2326 (2023). https://doi.org/10.1038/s41433-022-02342-6