June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
Onset of Improvement in Signs and Symptoms of Vernal Keratoconjunctivitis (VKC) in Patients Treated with Cyclosporine A Cationic Emulsion (CsA CE) in the NOVATIVE Study
Author Affiliations & Notes
  • Andrea Leonardi
    Department of Neuroscience, Ophthalmology Unit, Universita degli Studi di Padova, Padova, Veneto, Italy
  • Serge Doan
    Bichat Hospital and Foundation A. de Rothschild, France
  • Pierre-Jean Pisella
    Universite de Tours, Tours, Centre-Val de Loire, France
  • Mourad Amrane
    Santen SAS, France
  • Dahlia Ismail
    Santen SAS, France
  • Dominique Bremond-Gignac
    Hopital universitaire Necker-Enfants malades, Paris, Île-de-France, France
    INSERM Unit 1138 T17 Paris University, Paris, France
  • Footnotes
    Commercial Relationships   Andrea Leonardi Santen, Thea, Code C (Consultant/Contractor); Serge Doan Santen, Code C (Consultant/Contractor); Pierre-Jean Pisella Santen France, Code C (Consultant/Contractor); Mourad Amrane Santen SAS, Code E (Employment); Dahlia Ismail Santen SAS, Code E (Employment); Dominique Bremond-Gignac Alcon, Thea, Santen, Code C (Consultant/Contractor)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 892 – A0256. doi:
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      Andrea Leonardi, Serge Doan, Pierre-Jean Pisella, Mourad Amrane, Dahlia Ismail, Dominique Bremond-Gignac; Onset of Improvement in Signs and Symptoms of Vernal Keratoconjunctivitis (VKC) in Patients Treated with Cyclosporine A Cationic Emulsion (CsA CE) in the NOVATIVE Study. Invest. Ophthalmol. Vis. Sci. 2022;63(7):892 – A0256.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : NOVATIVE (NCT00328653) was a randomized phase II/lll trial that evaluated the efficacy and safety of CsA CE in children and adolescents with moderate-to-severe VKC. This analysis examined the time to onset of improvements in signs and symptoms of VKC in CsA CE treated patients.

Methods : 118 patients (mean age, 8.8± 3 y; 81.4% male) were randomized to 4x daily treatment with CsA CE 0.05%, 0.1%, or vehicle eye drops. Rescue treatment (corticosteroids, mast cell stabilizers, or antihistamines) was not allowed. The primary efficacy endpoint was overall rating of subjective symptoms at Day 28. Efficacy was evaluated based on change from Baseline in ratings of subjective symptoms (BenEzra’s 5-point scale) and in keratitis as identified by corneal fluorescein staining (CFS) and graded using the Oxford scheme.

Results : All NOVATIVE treatment groups showed improvement in overall subjective VKC symptoms at Day 28; however no statistically significant differences were noted between either CsA CE arm and the vehicle group. Although the primary end-point was not met, patients treated with CsA CE 0.05% and 0.1% showed improvement in subjective itching after 1 week and continued to improve through Month 1. Change from Baseline to Week 1 in the 0.1% treatment group was statistically significant (P=0.049). At Month 1, severe itching was reported by just 5.6% of patients in the 0.1% arm and none in the 0.05% arm vs 11.1% in the vehicle arm. All treatment groups showed improvement in CFS at Week 1; at Month 1 both CsA CE arms showed significantly greater improvements when compared to vehicle (P<0.05). Corresponding decreases in grade severity were also seen over time.

Conclusions : CsA CE 0.1% treatment led to a reduction in signs and symptoms in patients with moderate-to-severe VKC, with efficacy evident 1 week after initiating therapy. These data, along with data from the VEKTIS study, suggest that CsA CE 0.1% may be an effective corticosteroid-sparing VKC treatment.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.

 

 

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