■ A second administration of iDose TR and removal of the original iDose TR implant was safe and well tolerated in an exchange trial, Glaukos reported. The second implant demonstrated a favorable safety profile over 12 months and no subject had >30% endothelial cell loss during the extended evaluation period of more than 5 years. The company plans to submit an NDA in the coming months.

Glaukos initiated the exchange trial as per an FDA agreement to evaluate the feasibility and safety of a surgical exchange procedure of iDose TR in subjects who had the product in place as part of the phase 2b clinical trial. A total of 33 subjects were enrolled, 32 completed the trial, and the average time between implantation and exchange was 4.2 years. Subjects were then followed for an additional year after the second implantation, for an overall extended evaluation period average of 5.2 years.