EXPERIENCE THE EVIDENCE
OF RESTASIS®1,2

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

                                                       

Study Design:4,5 Multicenter, double-masked, randomized studies of the efficacy and safety of cyclosporine 0.05% ophthalmic emulsion used twice daily for up to 1 year in patients with moderate-to-severe keratoconjunctivitis sicca (KCS). Key efficacy and safety variables were assessed during the first 6 months in the vehicle-controlled double-masked treatment phase and further evaluated in a subset of patients for another 6 months in the double-masked cyclosporine-treatment extension phase.

CHANGES IN CORNEAL STAINING AND ARTIFICIAL TEAR USE3,6

Change in corneal staining from baseline°3,6

°Baseline mean values for corneal staining in different treatment groups ranged from 2.61 to 2.77 on the Oxford Scheme.3

A significant improvement in corneal staining was seen at 4 months and 6 months3

Change in average daily use of artificial tears from baseline♢6

♢Patient-estimated times per day that REFRESH® was used during the past week.6

A significant decrease in artificial tear use was seen by 6 months3

NS= Not significant.
‡‡Baseline mean values for corneal staining in different treatment groups ranged from 2.61 to 2.77 on the Oxford Scheme.3
†† Patient-estimated times per day that REFRESH® was used during the past week.
‡ P≤0.05.

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

Want to learn more about RESTASIS®? Request a rep visit.

request a rep

DOSING

One drop, twice a day, every day.

LEARN MORE

Access & Resources

Explore resources for patient affordability, prior authorization support, formulary coverage, and much more.

GET SUPPORT