FDA-APPROVED FOR 18 YEARS
and proven to help patients make
More of their own real tears.^*1,2
^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. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
*FDA approved 10/10/2003
RESTASIS® showed a significant increase in tear production at 6 months (primary endpoint)1,3
15% of RESTASIS® patients had an increase in Schirmer score ≥ 10mm (compared to 5% with vehicle).
Study Design:1,3 Multicenter, randomized, well-controlled clinical studies were performed in patients (N=877) with moderate-to-severe keratoconjunctivitis sicca (KCS). Efficacy of cyclosporine ophthalmic emulsion 0.05% twice daily was assessed based on Schirmer wetting versus vehicle at 6 months in patients whose tear production was presumed to be suppressed due to ocular inflammation.
sustained increase in tear production at 12 months4,5
Up to 39% increase in tear production at Month 12 vs baseline (pivotal extension one)4
Up to 35% increase in tear production at Month 12 vs baseline (pivotal extension two)5
Pivotal extension one: mean schirmer score values at baseline, 6 and 12 months4
Pivotal extension two: mean schirmer score values at baseline, 6 and 12 months5
CHANGES IN CORNEAL STAINING AND ARTIFICIAL TEAR USE3,6
Change in corneal staining from baseline°3,6
Change in average daily use of artificial tears from baseline♢6
191% increase in goblet cell density with RESTASIS® At 6 months (p=0.013) 6
Percent change from baseline in goblet cell density at 6 months 6
Percent change from baseline in goblet cell density at 6 months6
191% increase in goblet cell density with RESTASIS® at 6 months (p=0.013)6
MOST COMMON ADVERSE EVENTS
The most common adverse event reported in the RESTASIS® Full Prescribing Information is ocular burning (17%), which was transient and mostly mild to moderate in severity.1
Most common (≥3%) treatment-related AEs in Phase 3 studies3