Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension

Summary

This study will evaluate the efficacy and safety of bimatoprost SR in participants with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.

Timeline

Start

2014-12-15

Primary completion

2018-02-19

Completion

2019-07-19

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry analysis (non-inferiority test); Bimatoprost SR 15 μg vs Timolol 0.5%: Comparator; p = 0.0033; Least-squares Mean Difference -1.01 (95% CI -1.68 to -0.34); MMRM reads as mixed primary results NCT02247804 ↗

registry analysis (non-inferiority test); Bimatoprost SR 15 μg vs Timolol 0.5%: Comparator; p = 0.2950; Least-squares Mean Difference -0.41 (95% CI -1.17 to 0.36); MMRM reads as mixed primary results NCT02247804 ↗

release “Bimatoprost SR reduced IOP by approximately 30 percent over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to the study comparator, timolol.” reads as met primary endpoint abbvie.com ↗

Publications

• Weinreb RN, Bacharach J, Brubaker JW, Medeiros FA, Bejanian M, Bernstein P, Robinson MR. Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies. J Ocul Pharmacol Ther. 2023 Jan-Feb;39(1):55-62. doi: 10.1089/jop.2022.0137. Epub 2022 Nov 15.
• Medeiros FA, Sheybani A, Shah MM, Rivas M, Bai Z, Werts E, Ahmed IIK, Craven ER. Single Administration of Intracameral Bimatoprost Implant 10 microg in Patients with Open-Angle Glaucoma or Ocular Hypertension. Ophthalmol Ther. 2022 Aug;11(4):1517-1537. doi: 10.1007/s40123-022-00527-6. Epub 2022 May 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bimatoprost SR	Unknown	10 ug	Other
Subject	Bimatoprost SR	Unknown	15 ug	Other
Subject	Timolol	Other / unclassified	0.5 %	Topical

Indications