/ /

  • linkedin
  • Increase Font
  • Sharebar

    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.

    Related: Novel device provides rapid measure of tear osmolarity

    “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.”

    Recent: Hypochlorous acid eyelid wash reduces bacterial load

    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

    New Call-to-action

    1 Comment

    You must be signed in to leave a comment. Registering is fast and free!

    All comments must follow the ModernMedicine Network community rules and terms of use, and will be moderated. ModernMedicine reserves the right to use the comments we receive, in whole or in part,in any medium. See also the Terms of Use, Privacy Policy and Community FAQ.

    • 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.


    View Results