Does single bimatoprost implant administration give prolonged IOP control in glaucoma?
USA: A single bimatoprost implant administration leads to IOP control with an estimated probability of 75% at 6 months and 56% at 12 months, a recent study has revealed. The results from the Phase 3b Study were presented at the virtually held 2022 Association for Research in Vision and Ophthalmology (ARVO) annual meeting by Mahdi Basha, Fraser Eye Care Center in Fraser, Michigan.
"The duration of IOP control was in tune with the results of a previous phase 1/2 study by Craven et al.," Dr. Basha reported. "Not all patients included in the present analysis reached the month 12 visit, and the study is still enrolling. On study completion, safety outcomes will be reported, he said.
Intracameral bimatoprost implant slowly released bimatoprost for IOP lowering. The previous 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.
The analysis used data from a phase 3b clinical trial to investigate the longevity of IOP control following a single administration of the 10-µg bimatoprost implant.
The ongoing, open-label, multicenter, phase 3b study evaluated 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 judgment), residual implant size assessment, time from last administration, and safety evaluation. Rescue treatment (IOP-lowering medication or procedure) was allowed. The analysis included Kaplan-Meier estimates of time to rescue/retreatment following the day 1 implant administration in the study eye, and IOP in those participants not rescued/retreated. The analysis was done of the data available as of October 20, 2021.
The analysis included a total of 203 participants administered a 10-µg bimatoprost implant. The baseline mean IOP was 25.6 mmHg.
The analysis led to the following findings:
- Mean IOP and mean 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 of the probability of not requiring rescue/retreatment after a single administration of the bimatoprost implant was 97.4% at week 12; 74.6% at month 6; 65.1% at month 8; and 55.5% at month 12.
To conclude, "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.'
Reference:
Paper Abstract. Longevity of IOP Control Post Single Bimatoprost Implant Injection in a Phase 3b Study.
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