Prospective 18-Month Study of Bimatoprost Intracameral Implant in Patients with Open-Angle Glaucoma or Ocular Hypertension in US Clinical Practice

Overview

Journal Drugs

Specialty Pharmacology

Date 2025 Feb 13

PMID 39946034

Authors

Eric Mann

Jeffrey A Kammer

Gagan Sawhney

Jella An

Erica C Werts

Vanessa Vera

Marcos Rivas

Hongxin Lai

Sadhana Sonparote

E Randy Craven

Affiliations

Soon will be listed here.

Abstract

Background And Objective: Bimatoprost implant 10 µg (Durysta) is an intracameral biodegradable implant that releases bimatoprost to lower intraocular pressure (IOP). The purpose of this study was to prospectively collect effectiveness and safety data after administration of the implant in patients with open-angle glaucoma or ocular hypertension.

Methods: This phase IV, multicenter, prospective, observational, open-label, 18-month study (ARGOS) enrolled adult patients with open-angle glaucoma or ocular hypertension who were scheduled to receive the bimatoprost implant in one or both eyes. Data collected included IOP, use of topical IOP-lowering medications, treatment-emergent adverse events, and central corneal endothelial cell density. The primary endpoint was the proportion of primary (first-treated) eyes that received no additional (new) IOP-lowering treatment per standard medical care through month 6 after the implant administration.

Results: A total of 217 patients (341 eyes) were enrolled, and 132 patients (60.8%) and 203 eyes (59.5%) completed the study. Most patients were on topical IOP-lowering medication before receiving the implant. After implant administration, the proportion of primary eyes that had received no additional treatment was 88.6% (95% confidence interval 86.6-90.6) at month 6 (primary endpoint) and remained high throughout the follow-up: 83.7% (95% confidence interval 80.2-87.3) at month 12 and 77.7% (95% confidence interval 73.4-82.1) at month 18. Intraocular pressure was reduced after implant administration, with mean changes in IOP from baseline at follow-up visits ranging from - 1.0 to - 2.0 mm Hg. The mean number of topical IOP-lowering medications used was also reduced, from 1.8 at baseline to 0.9 at month 12 and 1.0 at month 18. Increased IOP and dry eye were the most common ocular treatment-emergent adverse events. The mean percentage change in central corneal endothelial cell density from baseline at month 18 (central reading center evaluation) was - 3.47%. In qualitative interviews, most patients (84%, 21/25) reported overall satisfaction with their treatment outcomes.

Conclusions: The bimatoprost implant helped control IOP and decrease topical medication use. Throughout the 18 months after implant administration, an estimated 77.7% of eyes required no new added medication for IOP management. Patient-reported outcomes were favorable, and the safety profile of the implant was acceptable.

Clinical Trial Registration: ClinicalTrials.gov identifier NCT04647214, registered 23 November, 2020.

References

Lewis R, Christie W, Day D, Craven E, Walters T, Bejanian M . Bimatoprost Sustained-Release Implants for Glaucoma Therapy: 6-Month Results From a Phase I/II Clinical Trial. Am J Ophthalmol. 2016; 175:137-147. DOI: 10.1016/j.ajo.2016.11.020. View

Weinreb R, Bacharach J, Brubaker J, Medeiros F, Bejanian M, Bernstein P . Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies. J Ocul Pharmacol Ther. 2022; 39(1):55-62. PMC: 9885540. DOI: 10.1089/jop.2022.0137. View

Reardon G, Kotak S, Schwartz G . Objective assessment of compliance and persistence among patients treated for glaucoma and ocular hypertension: a systematic review. Patient Prefer Adherence. 2011; 5:441-63. PMC: 3191921. DOI: 10.2147/PPA.S23780. View

Cordeiro M, Denis P, Astarita C, Belsey J, Rivas M, Garcia-Feijoo J . Prevalence of comorbidities with the potential to increase the risk of nonadherence to topical ocular hypotensive medication in patients with open-angle glaucoma. Curr Med Res Opin. 2024; 40(4):647-655. DOI: 10.1080/03007995.2024.2322048. View

Singh I, Berdahl J, Sarkisian Jr S, Voskanyan L, Ang R, Doan L . Long-Term Safety and Efficacy Evaluation of Travoprost Intracameral Implant Based on Pooled Analyses from Two Phase III Trials. Drugs. 2024; 84(10):1299-1311. PMC: 11512891. DOI: 10.1007/s40265-024-02074-9. View

Gedde S, Vinod K, Wright M, Muir K, Lind J, Chen P . Primary Open-Angle Glaucoma Preferred Practice Pattern®. Ophthalmology. 2021; 128(1):P71-P150. DOI: 10.1016/j.ophtha.2020.10.022. View

Dreer L, Girkin C, Campbell L, Wood A, Gao L, Owsley C . Glaucoma medication adherence among African Americans: program development. Optom Vis Sci. 2013; 90(8):883-97. PMC: 3923902. DOI: 10.1097/OPX.0000000000000009. View

Quaranta L, Novella A, Tettamanti M, Pasina L, Weinreb R, Nobili A . Adherence and Persistence to Medical Therapy in Glaucoma: An Overview. Ophthalmol Ther. 2023; 12(5):2227-2240. PMC: 10441906. DOI: 10.1007/s40123-023-00730-z. View

Nelson P, Aspinall P, Papasouliotis O, Worton B, OBrien C . Quality of life in glaucoma and its relationship with visual function. J Glaucoma. 2003; 12(2):139-50. DOI: 10.1097/00061198-200304000-00009. View

10.

Kashiwagi K, Matsuda Y, Ito Y, Kawate H, Sakamoto M, Obi S . Investigation of visual and physical factors associated with inadequate instillation of eyedrops among patients with glaucoma. PLoS One. 2021; 16(5):e0251699. PMC: 8121298. DOI: 10.1371/journal.pone.0251699. View

11.

Wu J, Varkhedi V, Radha Saseendrakumar B, Acuff K, Weinreb R, Baxter S . Social and Health Care Utilization Factors Associated With Ophthalmic Visit Nonadherence in Glaucoma: An All of Us Study. J Glaucoma. 2023; 32(12):1029-1037. PMC: 10840877. DOI: 10.1097/IJG.0000000000002300. View

12.

Schwartz G, Quigley H . Adherence and persistence with glaucoma therapy. Surv Ophthalmol. 2008; 53 Suppl1:S57-68. DOI: 10.1016/j.survophthal.2008.08.002. View

13.

Medeiros F, Walters T, Kolko M, Coote M, Bejanian M, Goodkin M . Phase 3, Randomized, 20-Month Study of Bimatoprost Implant in Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 1). Ophthalmology. 2020; 127(12):1627-1641. DOI: 10.1016/j.ophtha.2020.06.018. View

14.

Gatwood J, Brooks C, Meacham R, Abou-Rahma J, Cernasev A, Brown E . Facilitators and Barriers to Glaucoma Medication Adherence. J Glaucoma. 2021; 31(1):31-36. DOI: 10.1097/IJG.0000000000001965. View

15.

Kolko M, Tatham A, Lim K, Wells A, Shiu M, Uy H . Phase 3, Randomized, Comparison Study of Intracameral Bimatoprost Implant 10 µg and Selective Laser Trabeculoplasty. Am J Ophthalmol. 2025; 272:19-37. DOI: 10.1016/j.ajo.2024.12.026. View

16.

Olthoff C, Schouten J, van de Borne B, Webers C . Noncompliance with ocular hypotensive treatment in patients with glaucoma or ocular hypertension an evidence-based review. Ophthalmology. 2005; 112(6):953-61. DOI: 10.1016/j.ophtha.2004.12.035. View

17.

Jayanetti V, Sandhu S, Lusthaus J . The Latest Drugs in Development That Reduce Intraocular Pressure in Ocular Hypertension and Glaucoma. J Exp Pharmacol. 2020; 12:539-548. PMC: 7685378. DOI: 10.2147/JEP.S281187. View

18.

Newman-Casey P, Rhee D, Robin A, Mansberger S . Patient Challenges with Glaucoma Eye Drops: A Need to Identify Nonadherence and Facilitate Appropriate Support and Disease Management. Ophthalmol Glaucoma. 2025; . DOI: 10.1016/j.ogla.2024.12.002. View

19.

Leske M, Heijl A, Hussein M, Bengtsson B, Hyman L, Komaroff E . Factors for glaucoma progression and the effect of treatment: the early manifest glaucoma trial. Arch Ophthalmol. 2003; 121(1):48-56. DOI: 10.1001/archopht.121.1.48. View

20.

Newman-Casey P, Blachley T, Lee P, Heisler M, Farris K, Stein J . Patterns of Glaucoma Medication Adherence over Four Years of Follow-Up. Ophthalmology. 2015; 122(10):2010-21. PMC: 4581955. DOI: 10.1016/j.ophtha.2015.06.039. View