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Michael H Goldstein, Gregory Zarbis-Papastoitsis, Kathryn Golden, Cameron Wheeler, Joseph Kovalchin, Jennifer Agahigian, Karen Tubridy, Abbie Celniker, Eric S Furfine; Reduced Rescue Artificial Tear Use in Subjects Using a Topical Interleukin-1 (IL-1) Receptor-1 (R1) Blocker for Ocular Treatment of Dry Eye Disease (DED). Invest. Ophthalmol. Vis. Sci. 2014;55(13):3672.
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In therapeutic studies in dry eye disease (DED), the placebo response is well documented with a magnitude of effect of 20-35% on signs and symptoms of DED compared with baseline. This response is believed to be principally a result of two components: the placebo response typically seen in therapeutic drug trials and the wetting or lubricating effect of the topically applied vehicle. A third component, however, may play an important role in the vehicle response: the use of rescue artificial tears.
EBI-005 is a novel, potent IL-1R1 inhibitor that was rationally designed to treat ocular surface disorders, such as DED. In a double-masked, placebo-controlled study, 74 subjects with moderate to severe DED were randomized to receive vehicle control or EBI-005 (5 or 20 mg/mL). Subjects received the study medication 3x/day for 6 weeks and were allowed to use rescue artificial tears provided by the sponsor (Refresh plus®, Allergan Pharmaceuticals, Irvine, CA). Subjects recorded the number of vials of artificial tear used in a diary and were not allowed to use rescue tears within two hours of dosing of the study medication.
Mean rescue artificial tear use over the six week study period was 11.1 vials for subjects receiving EBI-005 and 31 vials for subjects receiving vehicle control (p value=.005). Median rescue artificial tear use over the six week period was 1 vial for subjects receiving EBI-005 and 10.5 vials for subjects receiving vehicle control. There was a lower percentage of users of large amounts of rescue artificial tears (defined as user of more than 50 vials during the 6 week study period) among subjects receiving EBI-005 (5% or 2 of 39) compared with vehicle control (35% or 9 of 26) (p value= .005). Of the 10 heaviest artificial tear users, eight (80%) were subjects receiving vehicle.
Subjects treated with EBI-005 used fewer rescue artificial tears than vehicle control treated subjects over the six week study period. Increased use of rescue artificial tears may play a key role in the magnitude of the vehicle response seen in many DED studies. Although not a currently acceptable regulatory endpoint in the United States, reduction of rescue artificial tear use by a study medication may have an important pharmacoeconomic impact that warrants further study.
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