The company states: "Glaukos announced positive results for a prospective, multi-center clinical trial designed to evaluate the safety of the surgical exchange procedure for iDose(R) TR in subjects who had previously been administered an iDose TR in the Phase 2b clinical trial. Results from the exchange trial demonstrated a second administration of iDose TR and removal of the original iDose TR implant was safe and well-tolerated, with the second iDose TR demonstrating a favorable safety profile over a 12-month evaluation period. Additionally, no subject in the exchange trial exhibited a greater than 30% endothelial cell loss over the extended evaluation period of more than five years on average. Glaukos plans to include the exchange trial’s positive data set in its upcoming FDA New Drug Application NDA submission targeted for the first quarter of 2023."
Published first on TheFly
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