Phase 3, Randomized, 20-Month Study of Bimatoprost Implant in Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 1)
Creators: name: FA Medeiros
name: TR Walters
name: M Kolko
name: Coote, Michael
name: M Bejanian
name: ML Goodkin
name: Q Guo
name: J Zhang
name: MR Robinson
name: RN Weinreb
name: A Agar
name: R Bathijia
name: L Liu
name: T Roberts
name: C Faschinger
name: C Vass
name: N Collignon
name: AC Alves Pereira
name: R Belfort De Mattos
name: FJ Dantas
name: MJ Lopes Da Silva
name: F Kanadani
name: L Magacho Dos Santos Silva
name: T Prata
name: D Bach-Holm
name: J Lai
name: C Tham
name: G Bátor
name: L Szalczer
name: B Varsányi
name: E Blumenthal
name: O Geyer
name: S Lavartovsky
name: T Pedut-Kloizman
name: N Shoham-Hazon
name: S Lujan
name: B Abela
name: RE Ang
name: EU Leuenberger
name: H Uy
name: MI Yap-Veloso
name: P Fryczkowski
name: P Jurowski
name: B Kalużny
name: J Kalużny
name: M Misiuk-Hojlo
name: K Raczynska
name: W Tomczyk-Dorozynska
name: J Wasyluk
name: S Zalewski
name: T Zarnowski
name: JG Feijoó
name: R Giménez-Gómez
name: EM Griño
name: AA López
name: MG Miralles
name: JM Moreno
name: V Polo
name: EC Taulet
name: BP Zúñiga
name: YY Chen
name: YC Lee
name: L Alpern
name: MS Berlin
name: J Brubaker
name: D Caldwell
name: A Camp
name: LB Cantor
name: R Caronia
name: CJ Crane
name: D Day
name: E Duzman
name: J Elfervig
name: S El-Harazi
name: R Evans
name: AC Fisher
name: WJ Flynn
name: CS Foster
name: R Frenkel
name: R Goyal
name: R Gross
name: PJ Hartman
name: WL Haynes
name: G Jerkins
name: J Kim
name: M Kim
name: B Kwapiszeski
name: B Lambright
name: C Larsen
name: J Lehmann
name: JH Levenson
name: D Logan
name: B McMillan
name: JR Martel
name: H Mayer
name: F Medeiros
name: S Moroi
name: A Moyes
name: J Myers
name: J Nairn
Publisher: name: La Trobe
Year: 2021
Subjects: Uncategorized

description: © 2020 American Academy of Ophthalmology Purpose: To evaluate the intraocular pressure (IOP)-lowering efficacy and safety of 10- and 15-μg bimatoprost implant in subjects with open-angle glaucoma (OAG) and ocular hypertension (OHT) after initial and repeated administrations. Design: Randomized, 20-month, multicenter, subject- and efficacy evaluator-masked, parallel-group, phase 3 clinical study. Participants: Adults with OAG or OHT in each eye, open iridocorneal angle inferiorly in the study eye, and study eye baseline IOP (hour 0; 8 AM) of 22–32 mmHg after washout. Methods: Study eyes received bimatoprost implant 10 μg (n = 198) or 15 μg (n = 198) on day 1 with readministration at weeks 16 and 32, or twice-daily topical timolol maleate 0.5% (n = 198). Intraocular pressure was measured at hours 0 and 2 at each visit. Main Outcome Measures: Primary end points were IOP and change from baseline IOP through week 12. Safety measures included treatment-emergent adverse events (TEAEs) and corneal endothelial cell density (CECD). Results: Both dose strengths of bimatoprost implant were noninferior to timolol in IOP lowering after each administration. Mean diurnal IOP was 24.0, 24.2, and 23.9 mmHg at baseline and from 16.5–17.2, 16.5–17.0, and 17.1–17.5 mmHg through week 12 in the 10-μg implant, 15-μg implant, and timolol groups, respectively. The incidence of corneal and inflammatory TEAEs of interest (e.g., corneal endothelial cell loss, iritis) was higher with bimatoprost implant than timolol and highest with the 15-μg dose strength. Incidence of corneal TEAEs increased after repeated treatment; with 3 administrations at fixed 16-week intervals, incidence of ≥20% CECD loss was 10.2% (10-μg implant) and 21.8% (15-μg implant). Mean best-corrected visual acuity (BCVA) was stable; 3 implant-treated subjects with corneal TEAEs had &gt;2-line BCVA loss at their last visit. Conclusions: Both dose strengths of bimatoprost implant met the primary end point of noninferiority to timolol through week 12. One year after 3 administrations, IOP was controlled in most subjects without additional treatment. The risk-benefit assessment favored the 10-μg implant over the 15-μg implant. Ongoing studies are evaluating other administration regimens to reduce the potential for CECD loss. The bimatoprost implant has potential to improve adherence and reduce treatment burden in glaucoma.