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    Lifitegrast data support dry eye efficacy over placebo drops

    Twice-daily drops showed improvement in eye dryness scores after two weeks


    Lifitegrast, on the other hand, according to the OPUS-2 authors (Ophthalmology. 2015; 122:2423-2431), is a “small-molecule integrin antagonist that blocks the interaction between intercellular adhesion molecule 1 and lymphocyte functional antigen 1, inhibiting T-cell adhesion, migration, activation, and subsequent cytokine release.”

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    In the OPUS-2 and OPUS-3 trials, investigators recruited a total of 1429 patients with Schirmer Tear Test scores from 1 to 10 mm, eye dryness scores of at least 40 on a 100-point scale (where 0 is no discomfort), corneal stain scores of greater than 2, and history of artificial tear use within 30 days of the study entry.

    Over a 15-day screening period, the participants received twice-daily doses of a placebo in both eyes.

    The researchers then randomly assigned half the participants to twice-daily doses of lifitegrast 5.0% and the other half to placebo-buffered saline eye drops for 84 days. During the treatment period (days 0-84), subjects received twice-daily doses of lifitegrast ophthalmic solution 5.0% or placebo administered to the ocular surface as a single eye drop (in the morning and in the evening just before bedtime) in each eye.

    At day 14, patients in both the lifitegrast and placebo groups reported improvements on the 100-point scale, but the improvement was 7.23 points greater for the lifitegrast group.

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    “This new medication delivered improvement in the eye dryness scores as early as 2 weeks in two study groups,” Dr. Matossian said.

    At day 42, both groups continued to improve with a 9.75-point advantage for the lifitegrast group.

    The improvements continued to day 84, with the difference between the groups holding more or less steady at 9.92 points.

    At all these time points, the difference between the two groups was statistically significant (p < 0.0001).

    Adverse effects, side effects

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