BACKGROUND: Lifitegrast ophthalmic solution, 5.0% is an anti-inflammatory agent indicated for the treatment of signs and symptoms of dry eye disease. This post-hoc analysis of phase 3 pivotal data identified patients with rapid and pronounced reduction in dry eye symptoms with lifitegrast treatment and evaluated defining characteristics.

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

RESULTS: The OPUS 2/3 analysis set included 1292 participants. The following 5 patient subgroups were identified in the lifitegrast treatment arm: 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 5 patient subgroups p><0.001), with numerically lower mean symptom scores for eye pain burning stinging foreign body sensation and photophobia in the patients demonstrating an early sustained response.>

CONCLUSION: The majority of patients treated with lifitegrast achieved =30% reduction in EDS by Day 84, with over half reaching 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 other subgroups, suggesting that early treatment may be beneficial for maximal response. Further studies to corroborate these findings are warranted.