Lifitegrast Therapy and Dry Eye Disease

USA: According to the findings of a post hoc study, lifitegrast therapy may be related to a reduction in the signs and symptoms of moderate to severe dry eye disease. The findings were published in JAMA Ophthalmology on 7th October 2021.

The results add to the overall evidence of the benefit of lifitegrast ophthalmic solution, 5.0%, in the treatment of signs and symptoms of DED, particularly in moderate to severe DED.

An investigation of the treatment effect of lifitegrast ophthalmic solution, 5.0%, in different subgroups by the severity of dry eye disease seems warranted. Edward J. Holland, Cincinnati Eye Institute, University of Cincinnati, Cincinnati, Ohio, and his team, therefore, investigated the heterogeneity of DED subgroups and identified which patients were most likely to improve clinically from lifitegrast therapy.

This post-hoc responder analysis was carried out using data from the phase 3 OPUS-2 and OPUS-3 investigations, which were 12-week prospective, double-masked, multicenter, placebo-controlled, randomized, parallel-arm clinical trials that previously established the effectiveness of lifitegrast in DED. The pooled data was divided into four subgroups depending on the severity of inferior corneal staining (ICSS; 1.5 versus >1.5) and ocular dryness (EDS; 60 vs 60) at baseline. Data were gathered between December 7, 2012, and October 5, 2015, and post-hoc analysis was carried out between April 14, 2020, and July 30, 2021.

Key Findings

• For the overall pooled population, responder and composite responder rates favored lifitegrast vs placebo (odds ratio range, 1.29 to 2.10).
• In the composite analysis, the subgroup with ICSS of greater than 1.5 and EDS of at least 60 at baseline (i.e., moderate to severe DED) demonstrated a 1.70- to 2.11-fold higher odds of achieving clinically meaningful improvement with lifitegrast across all sign and symptom end point pairs.

In conclusion, the findings of this post-hoc analysis might add to the overall evidence of lifitegrast's effectiveness in the treatment of DED signs and symptoms, particularly in moderate to severe DED. More clinical practice data would be beneficial in understanding the long-term benefit of lifitegrast and its effectiveness in subgroups with various degrees of DED severity, which would assist in optimizing therapeutic benefit for individual patients.

Reference

Holland EJ, Jackson MA, Donnenfeld E, et al. Efficacy of Lifitegrast Ophthalmic Solution, 5.0%, in Patients With Moderate to Severe Dry Eye Disease: A Post Hoc Analysis of 2 Randomized Clinical Trials. JAMA Ophthalmol. Published online October 07, 2021. doi:10.1001/jamaophthalmol.2021.3943