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    New dry eye treatment demonstrates rapid onset symptomatic relief

    Cincinnati, OH—In OPUS-3, the third Phase 3 randomized, placebo-controlled, double-masked study investigating lifitegrast ophthalmic solution 5.0% (Xiidra, Shire) for treatment of dry eye disease (DED), the novel immunomodulatory agent met its primary endpoint, significantly improving patient-reported eye dryness at day 84. Importantly, the benefit of lifitegrast compared with placebo for reducing the DED-related symptom was seen as early as day 14, said Edward J. Holland, MD.

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    “The outcomes in OPUS-3 replicated the symptom improvement results observed in the Phase 3 OPUS-2 study and supported the FDA approval of lifitegrast,” said Dr. Holland, director of cornea services, Cincinnati Eye Institute, Cincinnati, OH, and an investigator in OPUS-3.

    “It has been 13 years since a new medication was approved by the FDA for treatment of DED, and lifitegrast represents an important new option. Not only is it a unique immunomodulatory molecule that targets DED-related inflammation, but it provides the rapid symptomatic relief sought by patients who are bothered by DED.”

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    Lifitegrast is a small molecule integrin antagonist that interferes with T-cell activation, migration, and release of inflammatory mediators by preventing binding between lymphocyte function-associated antigen-1 (LFA-1) and intercellular adhesion molecule-1 (ICAM-1). LFA-1 is a surface protein found on T-cells and ICAM-1 is a surface protein found on antigen presenting cells and upregulated on the surface of conjunctival endothelial and epithelial cells in eyes with DED.

    OPUS-3 randomized 701 patients 1:1 to twice daily treatment with lifitegrast or placebo. Patients were eligible for inclusion if they had moderate-to-severe symptoms of DED as evidenced by an eye dryness score (EDS) ≥ 40 (rated on a visual analogue scale of 0 to 100 where 0 = none).

    More: Achieving physiologic restoration in dry eye

    Other key inclusion criteria required a Schirmer test without anesthesia result of ≥ 1 to ≤ 10 mm, corneal staining score ≥ 2.0, and a history of artificial tear use within 30 days of study entry.

    Change in the EDS from baseline to day 84 was the primary endpoint, and the data analysis showed a statistically significant treatment effect (7.16 points; p = 0.0007) favoring lifitegrast. Mean change from baseline was -37.9 in the lifitegrast group and -30.7 for placebo-treated patients.

    Secondary endpoint

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    • Anonymous
      Dry eye has been a huge problem for me growing up. I'm glad I've been able to get relief at Fite Eye Center.

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