July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018

Topical Cyclosporine A 1 mg/mL Cationic Emulsion Yields Improvements in Signs of Active Severe Vernal Keratoconjunctivitis (VKC) in Pediatric Patients: Results of the Phase III VEKTIS Study
Author Affiliations & Notes
  • Serge Doan
    Bichat Hospital and Foundation A. de Rothschild, Paris, France
  • Andrea Leonardi
    Department of Neuroscience, Ophthalmology Unit, University of Padua, Padua, Italy
  • Mourad Amrane
    Santen SAS, Evry, France
  • Dahlia Ismail
    Santen SAS, Evry, France
  • Jesus Montero
    Universidad de Sevilla, Sevilla, Spain
  • Pasquale Aragona
    Dipartmento de Scienze Biomediche, Universitá di Messina, Messina, Italy
  • Janos Nemeth
    Department of Ophthalmology, Semmelweis University, Budapest, Hungary
  • Dominique Brémond-Gignac
    University Hospital Necker Enfants Maladies, APHP, and Paris Descartes University, Paris, France
  • Footnotes
    Commercial Relationships   Serge Doan, Alcon (C), Allergan (C), Bausch & Lomb (C), Horus (C), Santen (C), Théa (C); Andrea Leonardi, Alcon (C), Bausch & Lomb (C), Dompè (C), Medivis (C), Santen (C), Théa (C); Mourad Amrane, Santen (C); Dahlia Ismail, Santen (E); Jesus Montero, None; Pasquale Aragona, Alcon Italia (C), Allergan (C), Dompè (C), Medivis (C), Santen (C), Sifi (C), Sooft (C), Théa (C), TRB Chemedica (C); Janos Nemeth, None; Dominique Brémond-Gignac, Alcon (C), Allergan (C), Horus (C), Santen (C), Théa (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 5572. doi:
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      Serge Doan, Andrea Leonardi, Mourad Amrane, Dahlia Ismail, Jesus Montero, Pasquale Aragona, Janos Nemeth, Dominique Brémond-Gignac;
      Topical Cyclosporine A 1 mg/mL Cationic Emulsion Yields Improvements in Signs of Active Severe Vernal Keratoconjunctivitis (VKC) in Pediatric Patients: Results of the Phase III VEKTIS Study. Invest. Ophthalmol. Vis. Sci. 2018;59(9):5572.

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

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Abstract

Purpose : Cyclosporine A cationic emulsion (CsA CE) for topical ocular use is an oil-in-water emulsion that remains longer on the ocular surface, thus optimizing its therapeutic effects. The VEKTIS study, a phase III, multicenter, double-masked, vehicle-controlled trial, evaluated the efficacy/tolerability of CsA CE 1 mg/mL eye drops for treating severe vernal keratoconjunctivitis (VKC) in pediatric pts.

Methods : 169 pts (4-18 yrs of age) with severe VKC and severe keratitis were randomized to 4 mos treatment with 1 of 2 active doses of CsA CE 1 mg/mL (high-dose [4x/day] or low-dose [CsA CE 2x/day + vehicle 2x/day]) or vehicle alone, followed by an 8-mos safety follow-up period when pts were rerandomized to 1 of the 2 active treatment arms. The primary endpoint (PE) was a mean composite score that reflected corneal fluorescein staining (CFS; modified Oxford scale), need for rescue medication, and occurrence of corneal ulceration over the first 4 mos. Pts were defined as responders at Month 4 if the mean CFS score of the last 3 mos of treatment was ≤50% of Baseline and they did not experience ulceration or use rescue medication over the last 3 mos.

Results : The PE (superiority of active treatment vs vehicle) was met; the difference in least-squares mean vs vehicle was significant for both the high-dose (0.76, p=0.007) and low-dose group (0.67, p=0.010). CFS score improvements (Fig 1) were the main driver, accounting for 70%, 78% of the treatment effect in the CsA CE high-dose and low-dose groups, respectively; reduced rescue medication use accounted for most of the rest (30% and 22%, respectively). There was no difference in mean number of corneal ulcer occurrences/month across treatment groups (0.001 for QID, 0.003 for BID; p=0.996 for both vs vehicle). The efficacy responder rate (via logistic regression analysis) was significantly higher in the high-dose (57.1%) and low-dose (61.1%), vs the vehicle group (34.5%)(p=0.015 and p=0.004, respectively). CFS reductions were stable over 8 mos follow-up (Fig 2). CsA CE was well tolerated.

Conclusions : In the phase III VEKTIS study, treatment with CsA CE 0.01% (1 mg/mL) yielded substantial improvements in signs of severe VKC in a pediatric pt population over 12 mos.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

 

 

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