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    Drug-delivery platforms offer more options and promise for clinicians

     

    Ocular Therapeutix        

    Ocular Therapeutix is best known for ReSure, an ocular wound sealant, but the company is developing a drug-eluting punctal plug. An NDA has been filed for Dextenza, a 30-day, sustained-release formulation of dexamethasone for post-surgical pain. The company is also working with the FDA to create a viable phase III study design for OTX-TP, a travoprost-eluting plug for glaucoma.

    “Once inserted, the plug hydrates and lodges in the canaliculus,” said Jonathan H. Talamo, MD, chief medical officer. “A single placement is designed to last 2 to 3 months delivery of preservative travoprost.”

    More: Check out a recap from the 2016 Glaucoma 360 gala!

    The device looks like a standard punctal plug, Dr. Talamo said, and is inserted like a punctal plug. Phase II trials in South Africa and the United States showed slightly less IOP lowering compared to timolol drops, but within the expected range. Both trials used a double-dummy design––an active plug with placebo drops in one arm and placebo plug with active drops in the other arm.

    The trial design raises questions about the results, he continued. It is possible that the dummy eye drops may dilute the effect of the latanoprost in the device. And it is equally possible that the inserted device enhances the effect of the Timolol drops.

    “We were encouraged by the phase II results and the clinically relevant IOP lowering out to 90 days,” Dr. Talamo said. “We also saw a consistent 90% retention rate and the device was easy to replace if needed.

    Ohr Pharmaceutical

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