Cost regulators for the NHS in England and Wales are asking for more information on Santen’s dry eye treatment Ikervis because the evidence provided is too uncertain.

The National Institute for Health and Care Excellence has published interim guidelines - which are now out for consultation - rejecting NHS use of Ikervis (ciclosporin) to treat severe keratitis in adults with drug eye disease which has not improved despite therapy with tear substitutes.

Keratitis is an inflammation of the cornea caused by reduced tear production or excessive tear evaporation, characterised by symptoms such as irritation and redness in the eyes, blurred vision, and a sensation of grittiness or a foreign body in the eye.

Ikervis has an anti-inflammatory effect on the cornea and tear gland by blocking the expression of pro-inflammatory cytokines, but the Institute’s Appraisal Committee noted that evidence on the relative cost and clinical effectiveness of the drug compared with established clinical practice was lacking.

As such, it has asked Santen to provide extra information - including comparisons for the clinical and cost effective of the Ikervis plus corticosteroids (if needed) and artificial tears, with that of corticosteroids (if needed) and artificial tears to help determine whether it can be funded on the NHS.