OPUS-3 showed significantly improved symptoms of eye dryness with lifitegrast, as measured by eye dryness score, versus placebo in those with dry eye disease.
The 12-week, randomized, double-masked, multicenter, placebo-controlled, phase 3 study included adults at least 18 years old who underwent a 14-day placebo run-in. Participants were randomized 1:1 to lifitegrast ophthalmic solution 5.0% (355 patients) or placebo (356 patients), twice daily for 84 days.
At day 84, lifitegrast-treated participants experienced significantly greater improvement from baseline in eye dryness score versus those receiving placebo, according to researchers.
Mean changes from baseline in eye dryness score also significantly favored lifitegrast on days 14 and 42.
In lifitegrast patients at day 42, a greater improvement was observed in itching, foreign body sensation and eye discomfort versus those receiving placebo.
OPUS-3 replicated and confirmed the results from the OPUS-2 study in a comparable study population, according to researchers.
“This finding is noteworthy because, according to our knowledge, statistically significant symptom improvements have not been demonstrated before in two separate phase 3 clinical studies of an investigational drug therapy for dry eye disease,” the researchers wrote.
In conclusion, the researchers propose that OPUS-2 and OPUS-3 suggest that lifitegrast improves symptoms of DED in participants with moderate to severe baseline symptomology. – by Abigail Sutton
: Holland is a consultant for Alcon Laboratories, Allergan, Bausch + Lomb, Kala Corp., Mati Therapeutics, Omeros, PRN, RPS, Senju Pharmaceuticals, Shire, TearLab and TearScience. He is a speaker for Alcon, Allergan, Bausch + Lomb, Omeros, Senju Pharmaceuticals, Shire and TearScience and has received research funds from Alcon, Allergan, Mati Therapeutics, Omeros, PRN and Senju Pharmaceuticals. For all remaining authors’ financial disclosures, please see the full study.