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

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.

• Authors: Christophe Baudouin, Maite Sainz de la Maza, Mourad Amrane, Jean-Sébastien Garrigue, Dahlia Ismail, Francisco C Figueiredo, Andrea Leonardi
• Journal: European journal of ophthalmology (Eur J Ophthalmol) Vol. 27 Issue 6 Pg. 678-685 (Nov 08 2017) ISSN: 1724-6016 [Electronic] United States
• PMID: 28708219 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Emulsions
• Immunosuppressive Agents
• Ophthalmic Solutions
• Cyclosporine
• Fluorescein

Topics

• Adult
• Aged
• Cyclosporine (adverse effects, therapeutic use)
• Double-Blind Method
• Dry Eye Syndromes (drug therapy)
• Emulsions (therapeutic use)
• Female
• Fluorescein (metabolism)
• Humans
• Immunosuppressive Agents (adverse effects, therapeutic use)
• Keratitis (drug therapy)
• Male
• Middle Aged
• Ophthalmic Solutions (adverse effects, therapeutic use)
• Tears (physiology)