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Cyclosporine A cationic emulsion improves keratitis, symptoms, QOL in severe VKC

Stephen Padilla
29 Apr 2019

High-dose cyclosporine A (CsA) cationic emulsion (CE) is well tolerated and effective in improving keratitis, symptoms and quality of life (QOL) in patients with severe vernal keratoconjunctivitis (VKC), according to a phase III study.

“[P]aediatric patients treated with CsA CE achieved significant improvements in the signs and symptoms of severe VKC compared with patients who received vehicle alone, with high-dose CsA CE showing more numerous conclusive statistical results vs vehicle than the low-dose group, much larger improvements in photophobia and mucous discharge, and much larger improvements for both QOL domains,” researchers said.

A total of 169 paediatric patients aged 4 to <18 years with active severe VKC (grade 4 or 5 on the Bonini severity scale) and severe keratitis (corneal fluorescein staining [CFS] score of 4 or 5 on the modified Oxford scale) were randomly assigned to either CsA CE 0.1% (1 mg/ml) eye drops four times daily (high dose), CsA CE twice daily (low dose) plus vehicle twice daily, or vehicle four times daily for 4 months.

A mean composite score that reflected CFS, rescue medication use (dexamethasone 0.1% four times daily) and corneal ulceration over 4 months was the primary endpoint.

Statistically significant differences were found in least-squares means vs vehicle for the primary endpoint for both high- (0.76; p=0.007) and low-dose (0.67; p=0.010) groups, with CFS score essentially driving the treatment effect. There were significant differences between both active treatment groups and vehicle for use of rescue medication. [Ophthalmology 2019;126:671-681]

All three groups showed improvements in VKC symptoms and patient QOL, assessed by visual analogue scale and the Quality of Life in Children with Vernal Keratoconjunctivitis questionnaire, with significant improvements for high-dose CsA CE compared with vehicle.

“Both doses of CsA CE demonstrated favourable safety profiles, which were similar between groups, with the exception of one treatment-related event—instillation site pain—which occurred more frequently in the high-dose group,” researchers said.

Furthermore, a low incidence of corneal ulcers was observed, and this can be attributed to the anti-inflammatory effects of CsA (eg, reduction of hyperaemia and CFS score) and the use of rescue medication in the event of disease worsening, according to researchers.

Results also showed some benefits of the CE vehicle on keratitis, which might explain the lack of a significant difference between the CsA CE and vehicle groups in terms of ulcer formation. Improvements in the vehicle group suggested a beneficial lubricating effect consistent with the known symptomatic benefits of artificial tears in VKC and changes in VKS severity during the allergy season, they added. [Ophthalmol Ther 2013;2:73-88; Acta Ophthalmol 2009;87:133-147]

“The effects of continued treatment with CsA CE are being assessed in an 8-month safety follow-up period and will be reported in a subsequent publication,” researchers said.

A chronic, allergic and potentially severe ocular disease affecting children and adolescents, VKA can result in impaired QOL as well as loss of vision.

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