PURPOSE: Lifitegrast ophthalmic solution, 5.0% (LIF) is an anti-inflammatory agent indicated for the treatment of signs and symptoms of dry eye disease. The purpose of this post-hoc analysis of Phase 3 pivotal data was to identify patients with rapid and pronounced reduction in dry eye symptoms with LIF treatment and identify defining characteristics.

METHODS: This is an exploratory analysis of data from the Phase 3 OPUS-2 and OPUS-3 studies (NCT01743729 NCT02284516), two 12-week, prospective, double-masked, multicenter, placebo-controlled, randomized, parallel-arm clinical trials. Pooled data in the LIF treatment arm were analyzed using a cluster analysis to identify homogenous populations of patient response types based on % change from baseline in eye dryness score (EDS; as evaluated on a VAS 0-100 scale) at Days 14, 42 and 84. Patients with Sjögren's syndrome or incomplete data were omitted from the analysis. Patient demographics and baseline characteristics amongst the defined subgroups were evaluated.

RESULTS: There were 1292 participants included in the OPUS-2/3 analysis set. The following 5 patient subgroups were identified in the LIF treatment arm from the cluster analysis: early sustained responders with ≥60% reduction in EDS at all timepoints (n=113; 17.7%); steady responders with ≥20%, ≥40% and ≥60% reduction in EDS at Days 14, 42, and 85 (n=113; 17.7%); Day 84 response of ≥60% (n=127; 19.9%); Day 84 response of ≤30% to <60% n="119;" 18.7 day 84 response of><30% n="166;" 26.0. there were significant differences in mean symptom scores across the five patient subgroups p><0.001), with numerically lower mean symptoms scores for pain burning stinging foreign body sensation and photophobia in the patients demonstrating an early sustained response.>

CONCLUSIONS: The majority of patients treated with LIF achieved ≥30% reduction in EDS by Day 84, with over half achieving a ≥60% reduction at this time point. The patient group with rapid and sustained EDS reductions by 2 weeks of treatment tended to have lower symptom scores than the rest of the subgroups, suggesting early treatment may be beneficial for maximal response. Further studies to corroborate these findings in other patient populations are warranted.