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Clinical Trial
. 2017 Nov 8;27(6):678-685.
doi: 10.5301/ejo.5001002.

One-Year Efficacy and Safety of 0.1% Cyclosporine a Cationic Emulsion in the Treatment of Severe Dry Eye Disease

Christophe Baudouin  1   2   3 , Maite Sainz de la Maza  4 , Mourad Amrane  5 , Jean-Sébastien Garrigue  5 , Dahlia Ismail  5 , Francisco C Figueiredo  6 , Andrea Leonardi  7
Affiliations
Clinical Trial

One-Year Efficacy and Safety of 0.1% Cyclosporine a Cationic Emulsion in the Treatment of Severe Dry Eye Disease

Christophe Baudouin et al. Eur J Ophthalmol. .

Abstract

Purpose: The SANSIKA study evaluated the efficacy/safety of 0.1% (1 mg/mL) cyclosporine A cationic emulsion (CsA CE) for treating dry eye disease (DED) with severe keratitis. The double-masked phase demonstrated that CsA CE was effective in reducing corneal damage and ocular surface inflammation, and was well-tolerated over 6 months. Here we report efficacy and safety findings of SANSIKA's open-label extension (OLE).

Methods: In this multicenter, double-masked, phase III study, patients with severe DED (corneal fluorescein staining [CFS] grade 4, modified Oxford scale) were randomized to once-daily CsA CE (Ikervis®) or its vehicle for 6 months, followed by 6-month open-label, once-daily CsA CE (CsA CE/CsA CE and vehicle/CsA CE groups).

Results: A total of 177 patients completed the OLE. Efficacy results reiterated the double-masked phase: CsA CE reduced CFS score and human leukocyte antigen-antigen D related expression, improved corneal clearing, and produced continuous improvements in global symptom scores (ocular surface disease index [OSDI], visual analogue scale). The CFS-OSDI response rates (≥2 CFS points, ≥30% OSDI improvement vs baseline) at 12 vs 6 months were 39.1% vs 28.6%, respectively, for CsA CE/CsA CE and 38.0% vs 23.1% for vehicle/CsA CE. Cyclosporine A CE's safety profile was similar to the initial 6 months. The most common treatment-related treatment-emergent adverse event was instillation site pain (7.8%, CsA CE/CsA CE group; 19.0%, vehicle/CsA CE group). No unexpected safety signals were observed; systemic CsA levels were undetectable/negligible in all patients except 2 previously treated with systemic CsA.

Conclusions: In this 12-month study, once-daily CsA CE was well-tolerated and showed reductions in ocular surface inflammation and improvements in signs/symptoms in DED patients with severe keratitis.

Keywords: Cationic emulsion; Cyclosporine; Inflammation; Keratoconjunctivitis sicca; Open-label extension; Severe keratitis.

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Conflict of interest statement

Conflict of interest: C. Baudouin is a consultant for or has received a research grant from Alcon, Allergan, Santen, and Théa, and was an international coordinator in the SANSIKA study. M. Sainz de la Maza was an investigator in the SANSIKA study. M. Amrane, J.S. Garrigue, and D. Ismail are employees of Santen SAS. F.C. Figueiredo is a consultant for Théa and Santen and was an investigator in the SANSIKA study. A. Leonardi is a consultant for or has received a research grant from Alcon, Allergan, Medivis, Santen, Sifi, and Théa, and was an investigator in the SANSIKA study.

Meeting presentation: Selected, previously unpublished data from this study were presented at the 7th annual World Congress on Controversies in Ophthalmology, March 31-April 3, 2016, Warsaw, Poland (Abstract #68); the Association for Research in Vision and Ophthalmology meeting, April 30-May 4, 2016, Seattle, Washington, USA (Abstract #2447672); and the 29th Asia-Pacific Association of Cataract and Refractive Surgeons annual meeting, July 27-30, 2016, Bali, Indonesia (Abstract # 264).

Figures

Fig. 1
Fig. 1
Corneal fluorescein staining ocular surface disease index (CFS-OSDI) responder rates over time. Patients randomized to 0.1% (1 mg/mL) cyclosporine A cationic emulsion (CsA CE) or vehicle during part 1 were switched to open-label CsA CE during part 2 (CsA CE/CsA CE and vehicle/CsA CE groups, respectively). Data represent responder rates of the full analysis set population. DMT = double-masked treatment; FAS = full analysis set; OLE = open-label extension.
Fig. 2
Fig. 2
Median human leukocyte antigen-antigen D related (HLA-DR) scores over time. Patients randomized to 0.1% (1 mg/mL) cyclosporine A cationic emulsion (CsA CE) or vehicle during part 1 were switched to open-label CsA CE during part 2 (CsA CE/CsA CE and vehicle/CsA CE groups, respectively). Baseline data are based on the patient population who participated in part 2 of the study. AUF = arbitrary units of fluorescence.
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References

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