Safety and Feasibility of the Exchange Procedure for the Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension.

INTRODUCTION

We conducted a prospective, single-arm, open-label study to evaluate the feasibility and safety of an exchange procedure for the travoprost intracameral implant.

METHODS

Adult subjects with open-angle glaucoma or ocular hypertension who had previously received a travoprost intracameral implant were enrolled at 12 sites in the United States and one in the Philippines. Subjects were administered a new travoprost intracameral implant followed by removal of the previous implant ("exchange" procedure). The primary outcome measures were treatment-emergent adverse events, and other ocular safety parameters (i.e., endothelial cell density, visual acuity, slit-lamp biomicroscopy, and visual fields).

RESULTS

Thirty-three subjects who had received a travoprost intracameral implant for a mean duration of 4.2 years prior were recruited. All subjects were successfully implanted with a new implant, and the previous implant was successfully removed. There were no treatment-related serious adverse events, or severe treatment-related adverse events in the eye that underwent the exchange procedure. No subject required a subsequent explantation.

CONCLUSIONS

Travoprost intracameral implant demonstrated an acceptable safety profile both during and after the exchange procedure, supporting its re-administration.

CLINICALTRIALS: gov NCT04615403.