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    Shire utilizing biotech approach to meet unmet ophthalmic needs

    Dry eye has a new class of treatment, lifitegrast (Xiidra, Shire). Approved in 2016, it is the first, and the only, lymphocyte function-associated antigen-1, or LFA1 antagonist, on the U.S. market.

    “We received approval of July 11 and went to market on August 29,” said Robert J. Dempsey, MBA, vice president and U.S. franchise head, Ophthalmics, Shire. “As we closed 2016, we had generated over 200,000 prescriptions and attained a market share of 20%. If you look at new-to-brand prescriptions, new patients put on the drug, we obtained over 50% market share. Since approval and going to market, we have seen the market for dry eye disease increase by over 45%.”

    Dempsey focused on the success of lifitegrast in an Industry Spotlight session during the New Horizons Forum, held in conjunction with the 2017 Glaucoma 360 meeting.

    There is a significant unmet need in dry eye as well as in glaucoma, age-related macular degeneration, and other ocular disease associated with aging,” Dempsey pointed out. Relatively few companies are targeting these conditions and none bring Shire’s experience in finding solutions in rare diseases and specialty.

    Shire, which built its experience in biotech agents, is taking a biotech approach to meeting unmet needs in both the anterior and poster segments, Dempsey added.

    Drug indication

    Lifitegrast is a twice daily ophthalmic topical drug indicated for both the signs and the symptoms of dry eye. It is marketed in single-use containers, 60 per foil pouch, for a 30-day supply.

    Like other ophthalmic agents, lifitegrast has side effects. The most common adverse events are dysguesia, slight burning or stinging upon installation, or blurred vision.

    The safety profile was based on 5 clinical trials with about 1,400 patients, Dempsey noted. Most of the patients, about 84%, had 3 months of exposure. The remaining 16% had longer exposure, including 170 patients who underwent 12 months of treatment.

    Early and clear communication with patients is the important step in managing these side effects.

    “When physicians have these discussions with patients upfront, these significant adverse events seem to be well-tolerated by patients,” Dempsey said. “To set patients up for success, we highly recommend having the discussions in advance and avoiding surprises.”

    Four clinical trials

    Fred Gebhart
    The author is a correspondent for Urology Times, a sister publication.

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