Abstract
Purpose :
Biodegradable, intracameral bimatoprost implant slowly releases bimatoprost to lower intraocular pressure (IOP). In clinical trials, the implant has provided sustained IOP lowering beyond the period of intraocular drug bioavailability. This analysis evaluated the duration of IOP control provided by the implant in a phase 3 clinical trials study extension.
Methods :
A 24-month, open-label, multicenter, long-term safety and efficacy extension study (NCT03891446) enrolled patients with open-angle glaucoma or ocular hypertension after their completion of a bimatoprost implant phase 3 clinical trial. Enrollment was optional; not all eligible patients enrolled. This analysis included patients who had received 10- or 15-µg bimatoprost implant in the study eye on Day 1 and Weeks 16 and 32 in a 20-month, randomized, phase 3 ARTEMIS trial (NCT02247804 or NCT02250651); patients were ineligible to receive implants during the study extension. Rescue with topical drops was allowed if the study eye did not meet/maintain IOP expectations (investigator decision). The analysis evaluated IOP and the number of patients who received no additional (rescue) IOP-lowering treatment in the study eye for ≥2 years after the last implant administration during the ARTEMIS trial. The study is ongoing; all data available as of 03 Dec 2020 were analyzed.
Results :
Among 181 implant-treated patients who completed ARTEMIS and enrolled in the study extension, 48 had not been rescued at the study extension screening, and 32 did not require rescue for ≥2 years after their last implant administration. For these 32 patients (16 treated with 10-µg implant, 16 with 15-µg implant), mean (±SD) time without rescue after the last implant administration was 2.6 ± 0.5 years (range, 2.0–4.0), and mean (±SD) IOP was 23.4 ± 1.9 mmHg at initial (ARTEMIS study) baseline and 18.1 ± 3.1 mmHg at the last recorded visit (still without rescue). Seven patients remained untreated for ≥3 years (range, 3.1–4.0); their mean (±SD) IOP was 22.8 ± 1.5 mmHg at baseline and 18.0 ± 4.1 mmHg at the last recorded visit (still without rescue).
Conclusions :
Patients treated with the bimatoprost implant can have a sustained IOP lowering and require no IOP-lowering treatment for ≥2 years after their last administration in a phase 3 trial. The implant releases drug for 3-4 months and the mechanism of action of the long duration of IOP reduction is under investigation.
This is a 2021 ARVO Annual Meeting abstract.