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Ocular implant gets fast-track designation
The FDA has granted fast-track designation to a silicone matrix ocular implant that helps prevent corneal transplant rejection.
Jersey City, NJ-The FDA has granted fast-track designation to a silicone matrix ocular (episcleral) implant (LX201, Lux Biosciences Inc.) that steadily releases therapeutic doses of cyclosporine A locally to the eye to prevent corneal transplant rejection.
The implant is being tested in a 1-year pivotal LUCIDA clinical trial program that comprises two controlled studies investigating its use in patients at elevated risk of immune-mediated rejection or graft loss after cornea transplantation. The device is implanted under the eyelid into the episcleral space in a minimally invasive procedure.
"With this fast-track designation, we can work [more rapidly] to provide a much-needed therapy to patients," said Ulrich Grau, PhD, president and chief executive officer of Lux Biosciences. "If successful, [the ocular implant] would become the first treatment available for the prevention of corneal transplant rejection."
The silicone matrix ocular implant has received orphan drug status in the United States and Europe.
