Xiidra versus Restasis
What is the difference? How do they each work? What are the benefits of Xiidra versus Restasis
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Xiidra: FDA Approved 2016
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Restasis 0.05%: FDA Approved 2003
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How Does it Work:
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Preservative-free solution of Lifitegrast 5% which is a small molecule integrin antagonist that blocks binding of ICAM-1 to LFA-1 on the T-cell surface, inhibiting T-cell recruitment and activation associated with DED inflammation.
Category: lymphocyte function-associated antigen 1 (LFA-1) antagonists.
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Is a topical immunomodulator indicated to increase tear production in patients whose tear production is presumed to be suppressed
-Is Cyclosporin A in a castor oil-in-water nanoemulsion, stabilized by polysorbate 80.
-Studies show it increase eyes’ natural ability to produce tears, which may be reduced by inflammation due to Chronic Dry Eye. RESTASIS® and RESTASIS MultiDose™ did not increase tear production in patients using anti-inflammatory eye drops or tear duct plugs
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Dose
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2x/day
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2x/day
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Side Effects
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Temporarily Burns when it goes in (keep in frig), tastes unpleasant in some (use punctal occlusion to keep drop in eye & not in throat); Allergy is rare (I have had 1 patient in hundreds will allergy to Xiidra); Does not work in 100% of pts.
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Temporary Burning feeling (in 15%); eye redness, discharge, watery eyes, eye pain, foreign body sensation, itching, stinging, and blurred vision. Allergy rare; Does not work in 100% of pts.
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Works in:
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Takes 2 weeks to work
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Usually takes 3 full months to work
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Cost
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1mo free sample if call 844-694-4747 with Rx from MD; otherwise: $400 per month if insurance does not cover it; pre-authorization often required
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$400 per month if insurance does not cover it; pre-authorization often required
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Comes in:
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individual vials; (many patients keep the drop in a clean ziplock bag in cup in refrigerator till vial runs out as long as tip has not touched a surface without infection)
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individual vials & New Multidose pack; company may be getting rid of vials soon.
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Use with Contact Lenses?
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Put in drop & wait 15min before using CLs; put in after CL removed in pm.
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Put in drop & wait 15min before using CLs; put in after CL removed in pm.
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Can it be used with Punctal Plugs
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Yes
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FDA trial showed Restasis did not increase tear production in patients with plugs in, but we have seen it help patient’s pain scores even if plugs are in but this has not been published. It does not appear to harm the eye if plugs are in & Restasis is used. See below Reference:
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More Info:
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4 separate multicenter, prospective, placebo-controlled, randomized, double-masked FDA clinical trials involving more than 1,000 subjects ranging in age from 19 to 97 with a predominance of female patients, at about 75%. Both the active drug and placebo were administered BID for 84 days, and safety and efficacy were determined between the groups. The study results revealed that the groups using Xiidra had a statistically significant clinical improvement in signs (corneal staining) and symptoms (eye dryness) compared with placebo. In the OPUS-3 study on symptoms of eye dryness, which involved 355 patients on Xiidra and 356 on placebo, Xiidra had a highly statistical improvement compared with placebo at day 84 (p=0.0007), day 42 (p<0.0001) and at 14 days after initiating therapy (p<0.0001).
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International Task Force guidelines for the treatment of dry eye and the American Academy of Ophthalmology Preferred Practice guidelines for dry eye recommend treatment with topical cyclosporine and/or topical corticosteroids prior to punctal plugs: say blocking tear drainage with punctal plugs may result in retention of inflammatory mediators on the ocular surface and exacerbation of ocular surface damage and patient discomfort. In Reference 1 below 1/3 (31.2%) of the patients who had a punctal plug procedure during the 2008–2009 period also filled a prescription for cyclosporine. Analysis of the order of treatment showed that among patients who had both punctal plug placement and a prescription for cyclosporine filled, the prescription fill typically occurred prior to punctal plug placement (59% of patients), consistent with current guidelines. But there have been many patients who have used Restasis with Punctal Plug: no clear side effects seen.
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A total of 61,039 patients had punctal plugs placed within the study period. Only 19,049 (31.2%) of these patients also filled a prescription for cyclosporine during the same 2-year period. A total of 9,903 of the patients who both filled a prescription for cyclosporine and had punctal plugs placed during 2008–2009 had data available for the 12 months before and after the first date of the plugs. Analysis of the timing of punctal plug placement and cyclosporine prescription fills in these patients showed that 59.0% of the patients filled a prescription for cyclosporine prior to punctal plug placement.
Overall, 38.5% of dry eye patients filled a prescription for topical cyclosporine, a topical corticosteroid, or an oral tetracycline, or underwent punctal plug placement during the study period (Table 6). A prescription for topical cyclosporine, a topical corticosteroid, or an oral tetracycline was filled by 35.5% of primary dry eye patients compared with 25.8% of nonprimary dry eye patients. In the chronic primary dry eye subset, 67.7% of patients filled a prescription for at least one of those three types of therapies (Table 6).
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References:
Ther Clin Risk Manag. 2013;9:409-15. doi: 10.2147/TCRM.S49754. Epub 2013 Oct 25.
Health claims database study of cyclosporine ophthalmic emulsion treatment patterns in dry eye patients.
Author information
Abstract
BACKGROUND:
Dry eye is a multifactorial, symptomatic disease associated with ocular surface inflammation and tear film hyperosmolarity. This study was designed to assess patterns of topical cyclosporine ophthalmic emulsion 0.05% (Restasis®) use in dry eye patients and determine if there were any differences in use based on whether dry eye is physician-coded as a primary or nonprimary diagnosis.
METHODS:
Records for adult patients with a diagnosis of dry eye at an outpatient visit from January 1, 2008 to December 31, 2009 were selected from Truven Health MarketScan® Research Databases. The primary endpoint was percentage of patients with at least one primary versus no primary dry eye diagnosis who filled a topical cyclosporine prescription. Data analyzed included utilization of topical corticosteroids, oral tetracyclines, and punctal plugs.
RESULTS:
The analysis included 576,416 patients, accounting for 875,692 dry eye outpatient visits: 74.7% were female, 64.2% were ages 40-69 years, and 84.4% had at least one primary dry eye diagnosis. During 2008-2009, 15.9% of dry eye patients with a primary diagnosis versus 6.5% with no primary diagnosis filled at least one cyclosporine prescription. For patients who filled at least one prescription, the mean months’ supply of cyclosporine filled over 12 months was 4.44. Overall, 33.9% of dry eye patients filled a prescription for topical cyclosporine, topical corticosteroid, or oral tetracycline over 2 years.
CONCLUSION:
Patients with a primary dry eye diagnosis were more likely to fill a topical cyclosporine prescription. Although inflammation is key to the pathophysiology of dry eye, most patients seeing a physician for dry eye may not receive anti-inflammatory