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    Shire's FDA-approved drug ends dry eye treatment drought



    “Dry eye is such an underappreciated problem,” said Edward Holland, MD, professor of clinical ophthalmology, University of Cincinnati, and clinical trial investigator for lifitegrast. He added it is rare for a medical disease to be so prevalent, but to have had only one treatment option.

    In addition to the 16 million patients diagnosed with dry eye, Dr. Holland said another 35 to 40 million are undiagnosed with the condition.

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    Numerous studies have examined quality-of life (QOL) effects for dry eye patients and found that QOL scores were similar to patients with severe chest pain due to angina.

    “Dry eye isn’t just an insignificant problem,” he said.

    Clinical Program

    The clinical program for lifitegrast included more than 2,500 patients, making it the largest investigational-stage dry eye disease candidate in history, Dr. Holland said.

    The safety and efficacy of the drug was studied in 1,181 patients (of which 1,067 received lifitegrast 5%) in four placebo-controlled, 12-week trials.

    Learn more about the previous trials here.

    Each of the studies assessed the drug’s effects at baseline, and at weeks 2, 6, and 12.

    The assessment of symptoms change was based on the different from the baseline patient reported eye dryness score (EDS; 0-100 visual analogue scale). Assessment of signs was based on inferior corneal staining score (ICSS; 0-4 scale)

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    In each study, a larger reduction of EDS was observed with the drug at weeks 6 and 12.

    In two of the four studies, an improvement in EDS was seen at 2 weeks for those taking lifitegrast. At week 12, a larger reduction in ICSS for patients treated with the drug was observed in three of the four studies.

    The fact that the drug was significant at week 2 “was a pleasant surprise,” Dr. Holland said.

    The most common adverse events reported in 5% to 25% of patients were instillation site irritation, altered taste sensation (dysgeusia), and blurred vision.

    The company resubmitted its drug application in February 2016 after the FDA required another clinical study and additional product quality information in late 2015.

    Dr. Holland said the agency’s initial rejection was not seen a negative response, and those at Shire were not discouraged because the FDA did not have the opportunity to analyze final data given the timing of the situation.

    How lifitegrast works

    Jolie Higazi
    Jolie is the Content Specialist for Ophthalmology Times. She can be reached at [email protected]

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    • [email protected]
      It sounds like a great news for potential dry eye patients. Its great that contact lenses are now better than what they used to be . You can shop them at gkb opticals
    • Anonymous
      It sounds like a great news for potential dry eye patients. Its great that contact lenses are now better than what they used to be . You can shop them at gkb opticals


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