Methods
STERILE
Two identically designed, randomized, multicenter, 20-month, phase 3 clinical trials (ARTEMIS 1 The patient eligibility criteria and methods for the ARTEMIS 1 and 2 studies have been reported in detail previously.On day 1, enrolled patients were randomly assigned to treatment with 10-μg bimatoprost implant, 15-μg bimatoprost implant, or twice-daily topical timolol maleate 0.5%. Patients in the bimatoprost implant treatment groups received a 10- or 15-μg bimatoprost implant in the study eye on day 1 and weeks 16 and 32. The bimatoprost implant was administered intracamerally using sterile technique under standard aseptic conditions for intraocular procedures.Implants were assessed on gonioscopy throughout the studies. The investigator reported whether implants were visible, identified the administration cycle for each visible implant (first, second, or third administration), and estimated the size of each visible implant compared with the initial implant size observed immediately after administration. Each investigator was given clear instructions on how to estimate the implant size, including use of the slit lamp beam as a reference for the size estimation. The investigator categorized and recorded the implant size as 0%–25%, 26%–50%, 51%–75%, 76%–100%, 101%–125%, 126%–150%, 151%–200%, or >200% of the initial size at implantation. The investigator also reported the location of each implant within iridocorneal angle zones, which were assigned around the corneoscleral limbus (Zones of implant location within the iridocorneal angle. The location of each implant within 1 of 12 zones arranged circumferentially around the iridocorneal angle was determined during gonioscopic examination. OD, right eye; OS, left eye.Data for the 10-μg implant administered on day 1 (first administration) were pooled from both completed studies for analysis. The analysis of biodegradation included all patients with implant size assessment data at the earliest (week 2) follow-up study visit with gonioscopic examinations. The percentage of the implants administered on day 1 that were no longer visible, or that were estimated to be 0%–25%, 26%–50%, 51%–75%, 76%–100%, 101%–125%, 126%–150%, 151%–200%, or >200% of the initial size, was evaluated at follow-up visits through month 20 (study exit). Clinically significant implant biodegradation was defined as implant either absent or ≤25% of the initial size.The percentage of visible implants located in each zone of the iridocorneal angle was evaluated at each follow-up visit through week 15 (the last visit before the second implant administration) using all observed data.