IKERVIS (ciclosporine)

Key points

Disapproval of reimbursement for the treatment of severe keratitis among adult patients presenting with dry eyes failing to resolve despite the instillation of artificial tears.

Role in therapeutic strategy?

The usual initial treatment of dry eye syndrome, regardless of cause, is based on:

• correcting contributing factors, wherever possible (medicinal products, environmental factors, eye drops containing preservatives, in particular quaternary ammoniums);
• and tear replacement therapy (artificial tears in the form of eye drops, gels, as well as viscoelastic solution medical devices used after the first two have failed).

After failure to respond to tear replacement therapy, several therapeutic options are used according to the degree of severity of the dry eye syndrome, its cause, and patient characteristics. The recommendations proposed by the International Dry Eye Workshop in 2017 particularly include:

• Step 1:
  • Education and dietary and environmental modifications, including potential elimination of offending systemic and topical medications,
  • Ocular lubricants (artificial tears) of various types,
  • Lid hygiene and compresses of various types.
• Step 2: if Step 1 options are inadequate, add:
  • Anti-inflammatory drugs including topical cyclosporin and limited-duration topical corticosteroids,
  • Tetracyclines (meibomitis, rosacea),
  • Punctal occlusion,
  • Topical secretagogues (e.g. rebamipide and diquafosol; not available in France),
  • Moisture chamber spectacles/goggles.
• Step 3: if Step 2 options are inadequate, add:
  • Oral secretagogues (e.g. pilocarpin)
  • Autologous serum,
  • Contact lenses/scleral lenses.
• Step 4: if Step 3 options are inadequate, add:
  • Topical corticosteroids for longer duration (off-label),
  • Permanent punctal occlusion,
  • Surgery (including amniotic membrane grafts),

These recommendations may be adapted by practitioners according to their personal clinical experience and each patient’s individual profile.

The Committee reiterates that, in the case of long-term use, the preservatives contained in eye drops may cause adverse inflammatory conjunctival effects and ocular surface toxicity, and hence preservative-free eye drops should be preferred.

Role of IKERVIS (ciclosporin) in the therapeutic strategy:

Considering:

• the lack of evidence, in the studies previous assessed (SANSIKA and SICCANOVE) of any superiority of IKERVIS (ciclosporin) versus placebo in patients with severe keratitis associated with dry eye syndrome failing to resolve despite the instillation of artificial tears.

• the new non-comparative data from phase 1 of the post-marketing study, which do not provide a basis to reach a conclusion on the efficacy of IKERVIS (ciclosporin) versus placebo in this patient cohort,
• the lack of availability of findings from phase 2 (comparative versus placebo) of this study (scheduled for 2023),

IKERVIS (ciclosporin) has no role in the therapeutic strategy for the management of severe keratitis among adult patients presenting with dry eyes failing to resolve despite the instillation of artificial tears.