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    Drug-loaded plug eases adherence issues for patients, physicians

    Dexamethasone intracanalicular depot provides sustained, tapered delivery with strong safety profile


    The plugs are eventually resorbed and flushed via the nasolacrimal system and do not need to be removed. The plugs can be engineered for longer or shorter persistence in the canaliculus and drug release depending on the clinical application.

    Related: How transcanalicular DCR helps nasolacrimal obstruction

    “These plugs are very easy to insert,” Dr. Gira said. “If the surgeon has placed punctal plugs before, and almost all of us have, it is the same technique you have used before. Not only does this drug depot take dexamethasone administration out of the patient’s hands, it’s far more convenient for the patient. They loved not having to worry about eye drops.

    “And as the surgeon, you don’t have to worry about them missing a dose or not using their drops at all,” he said. “Using an implantable drug depot is a win for everyone.”

    About the endpoints

    The two studies were each conducted at 16 unique sites across the United States. The first study had 247 patients randomly assigned to drug depot or placebo in a 2:1 ration. The second study had 240 patients randomly assigned. All patients had postoperative evaluations at days 2, 4, 8, 14, 30, and 60 following cataract surgery.

    Primary endpoints were the absence of anterior chamber (AC) cells, a score of zero, at day 14 and the absence of pain, also a score of zero, at day 8.

    Related: Can an intracameral mydriatic combination reduce need for pupil expanders?

    The first study met the primary endpoints for both pain (p < 0.0001) and inflammation (p = 0.0018), Dr. Gira noted. It also showed a strong safety profile.

    The second study met the pain endpoint (p = 0.0025) but failed to meet the inflammation endpoint (p = 0.2182). The second study also showed a strong safety profile.

    A pooled ad hoc analysis of the combined study populations met the inflammation endpoint (p = 0.0025). Both trials met two secondary inflammation endpoints, differences in mean AC cell score at days 8 and day 14 and absence of AC flare at days 8 and 14. The trial sponsor (Ocular Therapeutix) decided to pursue only the postoperative pain indication in its first FDA submission of the product.

    Recent: Increasing IOL power prediction accuracy

    A third phase III study for inflammation is planned, Dr. Gira said.

    “There were not huge differences in anterior chamber cells, and you can expect to see differences between surgeons, between different surgical platforms, and different techniques,” he said. “There will be more detailed analyses to identify the differences before they go back for another phase III trial.”

    Safety profile

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