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    Long-term implant showing potential in glaucoma therapy

    Biodegradable device has ‘excellent power, safety, and feasibility’ in phase IIa study

    Take-home message: By administering biannual combinations of small and large pellets of ENV515, researchers are finding a possible alternative to topical therapy for lowering IOP.

    Austin, TX—An extended-release therapy that encapsulates travoprost in an intracameral implant showed a statistically significant and clinically meaningful reduction in IOP with results comparable to topical once-daily travoprost ophthalmic solution, said Tom R. Walters, MD, Texan Eye, Austin.

    Developer Envisia used particle replication in non-wetting templates (PRINT) technology to create its proprietary and fully biodegradable implant designed to elute a drug for up to 6 months. Its first product, ENV515, is under evaluation for the treatment of glaucoma

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    “The PRINT technology has a lot of capability for sizing and shape that helps to determine how to best place this into the eye so that it is well-tolerated by the eye,” said Dr. Walters, who was an investigator for Envisia on these studies. The templates can be manufactured so that the end product eludes and dissolves at a very reproducible rate, he added. Early studies on hypertensive beagles found a rapid drop in pressure was maintained over 8 months.

    “That’s a quite remarkable feat,” Dr. Walters said. “It means we were able to make the product so that it’s able to hold on to the therapeutic agent as it dissolves. There was no evidence of the pharmaceutical agent leaching out of the material prematurely.”

    A phase IIa study enrolled 21 human patients with glaucoma and concurrent cataract who were being scheduled for cataract surgery. In a novel trial design, the ENV515 was placed at the time of cataract surgery and then purposefully removed after 4 weeks to assess efficacy implant status and determine efficacy and safety parameters.

    Often with biodegradable products, studies will evaluate performance but do not plan on removal. “We wanted to see how the pellet was tolerated, see what the effect of pressure-lowering was after 4 weeks, but also be able to extract that product and examine it to determine how it is eluding the pharmaceutical product,” Dr. Walters said, adding the company also evaluated the pellet’s size and weight to determine if it swelled or absorbed during implantation.

    “It helps us to design future iterations for longer-term studies,” he said.

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