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    Lifitegrast promising for patients using artificial tears

    Small-molecule integrin antagonist significantly reduced signs, symptoms in patients with dry eye disease

     

    Phase II data had shown a strong link between use of artificial tears and improvement with lifitegrast. OPUS-1 included a planned subanalysis of artificial tears users, a subset that comprised about 44% of the total OPUS-1 population of 588 patients. There were 129 placebo patients who used artificial tears in the 30 days before starting lifitegrast and 128 active ingredient patients. Artificial tears patients in both arms were well matched demographically and clinically, Dr. Sheppard said.

    More: Getting to the root cause of ocular allergy

    Dry eye signs began to improve by day 14 of the 12-week study for the lifitegrast arm, he continued. At day 84, both the inferior corneal staining score and the lissamine staining score had improved significantly (p = 0.0142 and p = 0.0128 respectively. )

    Dry eye symptom scores also showed significant improvement. Eye dryness improvement reached statistical significance by day 42 (p = 0.0013) and ocular discomfort by day 14 (p = 0.0179). By day 84, eye dryness and ocular discomfort scores in the lifitegrast arm showed even greater improvement over baseline compared to placebo (p = 0.0012 and p = 0.0001 respectively).

    “The symptom issue with OPUS-1 may be that patients, as a group, weren’t sick enough in terms of their dry eye symptoms to show a statistically significant change: a floor effect,” Dr. Sheppard said. “It has never been accomplished before that any symptoms have shown significant improvement in clinical trials, so the results of OPUS-1 were outrageously successful. It’s just that we didn’t call the right endpoints for the primary analysis.”

    Related: A tearscope made of paper?

    A confirmatory phase III trial, OPUS-2, has already been completed and the dataset locked, he continued. Enrollment criteria required more severe OSDI scores and eye dryness/ocular discomfort were selected as the primary symptom endpoints. Only artificial tear users will be included. Data analysis should be complete during the first quarter of 2014.

    “The results will create a tremendous amount of noise in the dry eye community,” Dr. Sheppard said. “I would expect the data to be expeditiously presented to the FDA. We should get an indication as to whether it is approvable by the end of 2014.”

    Update: Shire approved for one-of-a-kind dry eye drug

     

    John Sheppard, MD, MMSc

    E: [email protected]

    Dr. Sheppard was formerly a consultant for SARcode Bioscience. He is a clinical investigator for Shire Pharmaceuticals.

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