TY - JOUR
AU1 - Baudouin, Christophe
AU2 - de la Maza, Maite Sainz
AU3 - Amrane, Mourad
AU4 - Garrigue, Jean-Sébastien
AU5 - Ismail, Dahlia
AU6 - Figueiredo, Francisco C.
AU7 - Leonardi, Andrea
AB - PurposeThe 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).MethodsIn 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).ResultsA 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.ConclusionsIn 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.
TI - One-Year Efficacy and Safety of 0.1% Cyclosporine a Cationic Emulsion in the Treatment of Severe Dry Eye Disease
JF - European Journal of Ophthalmology
DO - 10.5301/ejo.5001002
DA - 2017-07-01
UR - https://www.deepdyve.com/lp/pubmed-central/one-year-efficacy-and-safety-of-0-1-cyclosporine-a-cationic-emulsion-JC3AJzbgGd
SP - 678
EP - 685
VL - 27
IS - 6
DP - DeepDyve
ER -