RESTASIS

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RESTASIS®: Favorable Safety Profile

In pivotal clinical trials, RESTASIS® (cyclosporine ophthalmic emulsion) 0.05% had:

NO detectable systemic drug absorption in the blood

NO known interaction with systemic drugs, including all "statin" drugs

NO increase in ocular infection

NO treatment-related changes in intraocular pressure (IOP), visual acuity, or biomicroscopy

Favorable Safety Profile

  • RESTASIS® is contraindicated in patients with active ocular infections and has not been studied in patients with a history of herpes keratitis
  • The most common side effect reported by 17% of patients was ocular burning (upon instillation)
  • Only 5 of 293 patients on RESTASIS® Ophthalmic Emulsion 0.05% discontinued due to burning and stinging1
  • Other side effects reported by 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign-body sensation, pruritus, stinging, and visual disturbance (most often blurring)

Reference

  1. Sall K, Stevenson OD, Mundorf TK, Reis BL, and the CsA Phase 3 Study Group. Two multicenter, randomized studies of the efficacy and safety of cyclosporine ophthalmic emulsion in moderate to severe dry eye disease. Ophthalmology. 2000;107:631-639.
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RESTASIS® Ophthalmic Emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.

Important Safety Information:

RESTASIS® is contraindicated in patients with active ocular infections and has not been studied in patients with a history of herpes keratitis.

The most common adverse event was ocular burning (upon instillation) – 17%. Other events reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring).

Please see full prescribing information for RESTASIS® (cyclosporine ophthalmic emulsion) 0.05%.