A new clinical study suggests that lifitegrast ophthalmic solution 5% may significantly improve symptoms and signs of dry eye disease when used twice daily over a 12-week period.¹

Published in The Ocular Surface, the study evaluated a formulation identified as KH732, a 5% lifitegrast ophthalmic solution designed to reduce inflammation associated with dry eye disease. Researchers conducted the trial using a twice-daily dosing regimen following a short washout period in which participants received a placebo-like vehicle solution before beginning active treatment. KH732 is a lifitegrast formulation developed by Chengdu Kanghong Pharmaceutical Group for registration in China.

Adults with moderate-to-severe DED and corneal staining score ≥2.0 in any corneal region were randomized 1:1 to lifitegrast (KH732) or vehicle twice daily for 84 days after a 3-7-day vehicle washout. The primary endpoint was change from baseline in inferior corneal staining score (ICSS) at Day 84. Secondary endpoints included changes in total corneal staining score, Eye Dryness Score (EDS), Ocular Surface Disease Index (OSDI), 7-item visual analogue scale, and Ocular Discomfort Score.

At Day 84, lifitegrast (n=309) significantly reduced ICSS versus vehicle (n=306) (P=0.027). In a post hoc analysis, the effect was more pronounced in participants with the highest baseline staining in the inferior region (P=0.046). Lifitegrast also significantly improved EDS (adjusted P=0.006), ocular discomfort (adjusted P=0.010), photophobia (adjusted P=0.004), and OSDI (adjusted P=0.014) versus vehicle. Post hoc analyses showed significant between-group differences in EDS, photophobia, and OSDI as early as Day 14. No serious ocular adverse events were reported.

Lifitegrast works by blocking interactions between proteins involved in inflammatory immune responses on the eye’s surface. The drug is already approved in several markets for dry eye disease, but researchers continue to study new formulations and dosing approaches aimed at improving patient outcomes and tolerability.

Researchers noted that additional long-term studies may help clarify how sustained treatment affects symptom control, adherence and overall eye health outcomes.

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