scholarly journals Topical ocular 0.1% cyclosporine A cationic emulsion in dry eye disease patients with severe keratitis: experience through the French early-access program

2018 ◽  
Vol Volume 12 ◽  
pp. 289-299 ◽  
Author(s):  
Pierre-Jean Pisella ◽  
Marc Labetoulle ◽  
Serge Doan ◽  
Beatrice Cochener-Lamard ◽  
Mourad Amrane ◽  
...  
Keyword(s):  
Dry Eye ◽  
Cyclosporine A ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Early Access ◽  
Access Program

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

2017 ◽  
Vol 27 (6) ◽  
pp. 678-685 ◽  
Author(s):  
Christophe Baudouin ◽  
Maite Sainz de la Maza ◽  
Mourad Amrane ◽  
Jean-Sébastien Garrigue ◽  
Dahlia Ismail ◽  
...  
Keyword(s):  
Dry Eye ◽  
Cyclosporine A ◽  
Ocular Surface ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Efficacy And Safety ◽  
Open Label ◽  
Once Daily ◽  
Surface Inflammation ◽  
Ocular Surface Inflammation

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.

Author's Reply to: “Concerns Over: Efficacy and Safety of 0.1% Cyclosporine a Cationic Emulsion in the Treatment of Severe Dry Eye Disease”

2017 ◽  
Vol 27 (6) ◽  
pp. e194-e195
Author(s):  
Andrea Leonardi ◽  
Gysbert Van Setten ◽  
Mourad Amrane ◽  
Dahlia Ismail ◽  
Jean-Sebastien Garrigue ◽  
...  
Keyword(s):  
Dry Eye ◽  
Cyclosporine A ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Efficacy And Safety

scholarly journals Once-Daily Cyclosporine-A-MiDROPS for Treatment of Dry Eye Disease

2018 ◽  
Vol 7 (5) ◽  
pp. 24 ◽  
Author(s):  
Terry G. Coursey ◽  
Ronald A. Wassel ◽  
Alexander B. Quiambao ◽  
Rafal A. Farjo
Keyword(s):  
Dry Eye ◽  
Cyclosporine A ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Once Daily

scholarly journals A Water-free 0.1% Cyclosporine A Solution for Treatment of Dry Eye Disease

Cornea ◽  
2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
John D. Sheppard ◽  
David L. Wirta ◽  
Eugene McLaurin ◽  
Blair E. Boehmer ◽  
Joseph B. Ciolino ◽  
...  
Keyword(s):  
Dry Eye ◽  
Cyclosporine A ◽  
Dry Eye Disease ◽  
Eye Disease
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