IKERVIS (ciclosporin), ophthalmic medicinal product

OPHTHALMOLOGY - New medicinal product
Opinions on drugs - Posted on Apr 07 2016

Reason for request

Inclusion

In the treatment of severe keratitis with dry eye disease, no clinical benefit demonstrated compared with eye drops that do not contain ciclosporin.

  • IKERVIS is an eye-drop emulsion based on ciclosporin that is indicated in the treatment of severe keratitis in adult patients with dry eye disease that has not improved despite the instillation of tear substitutes. 
  • Two studies did not demonstrate the superiority of ciclosporin compared with a reference emulsion in terms of improvement in symptoms of dry eye disease after 6 months of treatment. Exploratory results suggest that IKERVIS has a positive effect on the progression of keratitis and on signs of inflammation on the ocular surface.
  • In combination with tear substitutes or treatments that increase tear persistence, IKERVIS is a second-line treatment.

 


Clinical Benefit

Low

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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