September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Topical ocular ciclosporin 1 mg/mL cationic emulsion in patients with dry eye with severe keratitis: Experience through the French early access program
Author Affiliations & Notes
  • Serge Doan
    OPHTHALMOLOGY, Bichat Hospital & A de Rothschild Foundation, Paris, France
  • Pierre-Jean Pisella
    University François Rabelais, Tours, France
    Department of Ophthalmology, Bretonneau Hospital, Tours, France
  • Beatrice Cochener
    Brest University Medical School, Morvan Hospital, Brest, France
  • Mourad Amrane
    Santen SAS, Evry, France
  • Dahlia Ismail
    Santen SAS, Evry, France
  • Christophe Baudouin
    Quinze-Vingts National Ophthalmology Hospital, Paris, France
    UPMC University, Paris 6, Vision Institute, INSERM UMRS968, CNRS UMR7210, Paris, France
  • Marc Labetoulle
    Department of Ophthalmology, Bicêtre Hospital, APHP, Paris-Sud University, Le Kremlin-Bicêtre, France
  • Footnotes
    Commercial Relationships   Serge Doan, Alcon (C), Allergan (C), Bausch&Lomb (C), Horus (C), Santen (C), Thea (C); Pierre-Jean Pisella, Abott (C), Alcon (C), Allergan (C), Santen (C), Thea (C); Beatrice Cochener, Alcon (C), AMO (C), Bausch & Lomb (C), Physiol (C), RVO (C), Santen (C), Thea (C); Mourad Amrane, Santen SAS (E); Dahlia Ismail, Santen SAS (E); Christophe Baudouin, Alcon (C), Allergan (C), Santen (C), Thea (C); Marc Labetoulle, Alcon (C), Allergan (C), Santen (C), Thea (C)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 2876. doi:
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      Serge Doan, Pierre-Jean Pisella, Beatrice Cochener, Mourad Amrane, Dahlia Ismail, Christophe Baudouin, Marc Labetoulle; Topical ocular ciclosporin 1 mg/mL cationic emulsion in patients with dry eye with severe keratitis: Experience through the French early access program. Invest. Ophthalmol. Vis. Sci. 2016;57(12):2876.

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      © 2017 Association for Research in Vision and Ophthalmology.

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Abstract

Purpose : To measure the efficacy and safety of ciclosporin 1 mg/mL cationic emulsion (CsA CE) in patients with dry eye disease (DED) with severe keratitis or corneal lesions that do not improve despite tear substitutes in a French early access program.

Methods : A compassionate-use program (cohort temporary authorization for use [ATU]) for CsA CE was agreed with the French national authorities (ANSM) for the period of 29 October 2013 through 7 June 2015. A total of 1212 patients were enrolled. Patients with DED had to have severe keratitis defined by a corneal fluorescein staining (CFS) score of 3–5 on the Oxford scale and/or presence of filaments and/or corneal ulcers. Efficacy and safety of CsA CE were assessed at Month 1, Month 3, Month 6 and Month 12 visits.

Results : Overall, 93.6% of patients presented with severe keratitis based on the Oxford scale, and 74.5% had severe corneal lesions. The mean age was 60.5±16.3 years, and 79.5% were women. The mean duration of DED was 5.0 years, and the main etiology was Gougerot-Sjögren syndrome (48.7%). At inclusion in the CsA CE cohort ATU, the majority of patients (99.0% [1164]) had no improvement despite the use of tear substitutes; 50.4% of patients were switched to CsA CE from either RESTASIS® (anionic CsA emulsion 0.05%) (43.8%) or hospital CsA formulations (6.6%). Clinical benefit was observed from Month 1 through Month 12 (Table 1) for both CsA-naïve and CsA-pretreated patients. Nearly half of patients consistently demonstrated either stabilization or improvement in symptoms and signs (keratitis) of dry eye. In addition, the proportion of patients who reached CFS Grade 0 on the Oxford scale (corneal clearing) increased from Month 1 through Month 12. No specific safety signal was identified. The main adverse events reported were ocular and expected with the use of ciclosporin, consisting of ocular pain and eye irritation (93 and 50 events, respectively).

Conclusions : This compassionate-use program (cohort ATU) in France has provided supporting data on the benefit of CsA CE in improving corneal damage and symptoms in patients with DED with severe keratitis in real-life practice.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

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