Abstract
Purpose :
Intracameral bimatoprost implant slowly releases bimatoprost to lower intraocular pressure (IOP). Previously reported phase 3 studies of the implant (ARTEMIS) evaluated IOP lowering post single administration only through 15 weeks, because 2 additional implants were administered at 16-week intervals. This analysis used data from a phase 3b clinical trial to evaluate the longevity of IOP control after single administration of the 10-µg bimatoprost implant.
Methods :
Ongoing, open-label, multicenter, phase 3b study (NCT03850782) evaluating bimatoprost implant pro re nata in patients with open-angle glaucoma or ocular hypertension inadequately managed with topical IOP-lowering medication for reasons other than efficacy (eg, intolerance or nonadherence). Retreatment criteria were based on clinically meaningful IOP increase (investigator judgement), time from last administration, residual implant size assessment, and safety evaluation. Rescue treatment (IOP-lowering medication or procedure) was allowed. Analysis included Kaplan-Meier estimates of time to rescue/retreatment after the day 1 implant administration in the study eye, and IOP in those participants not rescued/retreated. Data available as of October 20, 2021 were analyzed.
Results :
A total of 203 participants administered a 10-µg bimatoprost implant were included in the analysis. Baseline mean (SD) IOP was 25.6 (2.97) mmHg. Mean (SD) IOP and mean (SD) change from baseline (mmHg) in those not rescued/retreated were 17.6 (3.77) and −7.9 (3.90) at week 12 (n=175); 18.3 (4.40) and −6.6 (4.12) at month 6 (n=114); 18.5 (4.17) and −6.1 (4.05) at month 8 (n=74); and 18.5 (3.52) and −5.9 (3.81) at month 12 (n=47). The Kaplan-Meier estimate (95% CI) of the probability of not requiring rescue/retreatment after a single administration of the bimatoprost implant was 97.4% (93.8%, 98.9%) at week 12; 74.6% (67.0%, 80.8%) at month 6; 65.1% (56.5%, 72.4%) at month 8; and 55.5% (46.1%, 63.9%) at month 12.
Conclusions :
Based on the available data, the estimated probability of IOP control after a single bimatoprost implant administration was 75% at 6 months and 56% at 12 months. The duration of IOP control is consistent with results of a previous phase 1/2 study (Craven et al. Drugs. 2020;80:167-79). Not all participants included in the present analysis had reached the month 12 visit, and the study is still enrolling. Safety outcomes will be reported at study completion.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.