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Dominique Bremond-Gignac, Pasquale Aragona, Serge Doan, Mourad Amrane, DAHLIA ISMAIL, Jesús Montero, János Németh, Andrea Leonardi; Safety and Tolerability of Topical Cyclosporine A Cationic Emulsion in Patients With Active Severe Vernal Keratoconjunctivitis (VKC) in Pediatric Patients: Pooled Results of the NOVATIVE and VEKTIS Trials. Invest. Ophthalmol. Vis. Sci. 2019;60(9):6710.
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© ARVO (1962-2015); The Authors (2016-present)
Cyclosporine A cationic emulsion (CsA CE) for topical ocular use is approved in the EU for treatment of severe vernal keratoconjunctivitis (VKC), a rare allergic ocular disease, in pediatric patients. Supporting data were derived from a Phase II/III (NOVATIVE) and a Phase III (VEKTIS) multicenter, double-masked, vehicle-controlled trial. Here we present pooled safety data from these 2 trials.
In NOVATIVE, 118 patients with active VKC were randomized to 1 of 3 treatment groups: CsA CE 0.05%, 0.1% or vehicle administered 4 times daily (QID) for 4 weeks. In VEKTIS, 169 patients who had severe VKC with severe keratitis were randomized to 4-month treatment with CsA CE 0.1% QID (high-dose), BID (low-dose) or to the vehicle QID. For this analysis, safety data from the 2 studies were pooled (0.05% QID arm in NOVATIVE pooled with 0.1% BID data in VEKTIS).
NOVATIVE found improvement in subjective VKC symptoms in all groups, and superiority of CsA CE over vehicle on corneal fluorescein staining (CFS), with the most notable benefits seen in severe VKC. In VEKTIS, the primary endpoint of superior improvement over vehicle in a composite efficacy score reflecting CFS, need for rescue medication, and occurrence of corneal ulcer over 4 months was met with both CsA CE dosing regimens. In the pooled population, adverse events (AEs) were reported in 37.5%, 34.4% and 37.8% of patients in the high-dose, low-dose, and vehicle groups, respectively. Most drug-related AEs were of mild/moderate severity and most AE-related treatment discontinuations occurred in the vehicle group (Table 1). The most frequent ocular drug-related AEs reported were instillation site pain (9.4%, 7.5% and 4.1% in the high-dose, low-dose and vehicle groups) and instillation site pruritus (5.2%, 7.5% and 3.1%, respectively). Non-ocular drug-related AEs included 1 report each of rhinorrhea and headache in the high-dose group and 1 case each of throat tightness, rash and urticaria in the vehicle group. Systemic absorption of CsA was negligible.
Analysis of pooled safety data from 2 trials of CsA CE in pediatric patients with VKC suggest a good tolerability/safety profile. Effects appear to be confined to the eye as evidenced by limited drug-related systemic AEs.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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