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
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.
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.
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
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
Most common (≥3%) treatment-related AEs in Phase 3 studies3
RESTASIS® and RESTASIS MultiDose® ophthalmic emulsion are 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.
RESTASIS® and RESTASIS MultiDose® are contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation.
POTENTIAL FOR EYE INJURY AND CONTAMINATION: Be careful not to touch the container tip to your eye or other surfaces to avoid potential for eye injury and contamination.
USE WITH CONTACT LENSES: RESTASIS® and RESTASIS MultiDose® should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of RESTASIS® and RESTASIS MultiDose® ophthalmic emulsion.
In clinical trials, the most common adverse reaction following the use of cyclosporine ophthalmic emulsion 0.05% was ocular burning (upon instillation)—17%. Other reactions 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
*Source: Symphony Health Managed Markets Vantage, November 2018 - October 2019. Data are subject to change. Data are not a guarantee of coverage, or partial or full payment, by any payers. Actual benefits determined by respective plan administrators, insurer plans, coverage criteria, and formularies are subject to change without notice. Check each patient’s coverage with applicable insurer. Allergan does not endorse any individual plans. Formulary coverage does not imply efficacy or safety.
†Insurer plans, coverage criteria, and formularies are subject to change without notice. Check each patient’s coverage with the applicable insurer. Allergan does not endorse any individual plans. Formulary coverage comparisons are not intended to imply a comparison of efficacy, safety, therapeutic equivalence, or overall cost of care.
1. Restasis® Prescribing Information. June 2017. 2. RESTASIS MultiDose® Prescribing Information. October 2016. 3. Sall K, Stevenson OD, Mundorf TK, Reis BL; CsA Phase 3 Study Group. Two multicenter, randomized studies of efficacy and safety cyclosporine ophthalmic emulsion in moderate to severe dry eye disease [published correction appears in Ophthalmology. 2000;107(7):1220.] Ophthalmology. 2000;107(4):631-639. 4. Data on file. Allergan, Inc., 1999; Clinical Study Report 192371-002. 5. Data on file. Allergan, Inc., 1999; Clinical Study Report 192371-003. 6. Data on file. Allergan, Inc., 1999; RESTASIS New Drug Application: Integrated Summary of Efficacy.
