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    Sustained-release insert aids patient noncompliance

    Dexamethasone for intracanalicular use provides better modality for postoperative therapy

    Patient noncompliance with eye drop regimens is inconvenient, and as surgeons, we surrender control the moment a patient walks out the door.

    Despite the tremendous innovations, surgeons have seen in the technology available to increase the precision and safety of cataract surgery, little has changed for the patient postoperatively.

    Pharmaceutical manufacturers have responded to the patient and physician need to simplify postsurgical drug administration. Dexamethasone insert 0.4 mg (Dextenza, Ocular Therapeutix) for intracanalicular use offers a drug product candidate which may serve as a new modality for steroid drug delivery, replacing the current month-long, tapering, multiple-times-a-day regimen.

    The sustained-release, non-invasive, bioresorbable corticosteroid insert is being evaluated by the FDA for the treatment of ocular pain occurring after ophthalmic surgery. The FDA has set a PDUFA target action date for July 19, 2017.

    Following surgical procedure, the surgeon inserts the drug product candidate through the punctum and into the canaliculus, thus enabling control of the entire course of postoperative steroid therapy with a single administration.

    Preferred by patients

    A recently published study, designed to evaluate the overall patient experience and perceived value of the dexamethasone insert following cataract surgery, found patients overwhelmingly prefer the sustained-release insert over traditional drop therapy.

    The qualitative evaluation consisted of interviews with 25 patients at four U.S. investigational study sites who had received a dexamethasone insert during the phase III study program.

    Most patients (92%) reported the highest level of satisfaction grade with regard to overall product satisfaction. All patients (100%) described the insert as comfortable.

    Twenty-two of 23 (96%) participants rated their experience with the insert as “very” or “extremely convenient,” compared with previous topical therapy, and 88% of patients stated if they were to undergo cataract surgery again, they would specifically request the insert.

    When asked if they would recommend the insert to family members or friends, 92% stated they would.

    The survey also found that 84% of participants would be willing to pay more for the insert than for eye drop therapy.

    Phase III trial program results

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