Indication for Restasis (Cyclosporine Ophthalmic Emulsion 0.05%)
Restasis is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye disease). 1
FDA-Approved Indication
The FDA has specifically approved cyclosporine ophthalmic emulsion 0.05% for patients with dry eye disease where reduced tear production is presumed to result from ocular inflammation. 1 This represents the first immunomodulatory agent approved for dry eye treatment, addressing the inflammatory mechanism underlying keratoconjunctivitis sicca. 2
Key Patient Selection Criteria
Patients must have documented reduced tear production presumed secondary to ocular inflammation. 1 The following clinical scenarios warrant consideration:
- Patients with moderate to severe dry eye disease caused by keratoconjunctivitis sicca who have inadequate tear production 2
- Patients with aqueous-deficient dry eye (one of the two main forms of dry eye disease) 2
- Emerging evidence suggests potential benefit for meibomian gland dysfunction (evaporative dry eye), though this is not the primary FDA-approved indication 2
Important Contraindications to Use
Restasis should NOT be used in patients currently taking topical anti-inflammatory drugs or using punctal plugs, as increased tear production was not demonstrated in these populations during clinical trials. 1 This is a critical exclusion criterion that practitioners must evaluate before prescribing.
Clinical Context
The medication addresses the inflammatory pathophysiology of dry eye disease, where tear film alterations include both reduced tear volume and increased inflammatory cytokines and osmolarity. 3 This immunomodulatory approach represents a paradigm shift from purely symptomatic treatment to addressing the underlying disease mechanism. 2
Treatment Expectations
Restasis is designed for long-term management of chronic dry eye disease, as this condition typically requires extended therapy. 3 Patient education about the need for prolonged treatment is essential for therapeutic success, particularly since some patients may initially experience burning or stinging that can lead to premature discontinuation. 3