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24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients

journal contribution
posted on 04.01.2021, 00:44 by ER Craven, T Walters, WC Christie, DG Day, RA Lewis, ML Goodkin, M Chen, V Wangsadipura, MR Robinson, M Bejanian, T Aung, AD Beck, JD Branch, Michael Coote, CJ Crane, A Crichton, S Day, FJ Durcan, RM Evans, WJ Flynn, S Gagné, DF Goldberg, JV Greiner, P Jeppsen, D Jinapriya, CS Johnson, S Kurtz, SL Mansberger, JR Martel, SA Perera, MH Rotberg, RM Saltzmann, HI Schenker, ME Tepedino, MIR Yap-Veloso, HS Uy, TR Walters
© 2019, The Author(s). Objective: The objective of this study was to evaluate the safety and intraocular pressure (IOP)-lowering effects over 24 months of biodegradable bimatoprost sustained-release implant (Bimatoprost SR) administration versus topical bimatoprost 0.03% in patients with open-angle glaucoma (OAG). Methods: This was a phase I/II, prospective, 24-month, dose-ranging, paired-eye controlled clinical trial. At baseline following washout, adult patients with OAG (N = 75) received Bimatoprost SR (6, 10, 15, or 20 µg) intracamerally in the study eye; the fellow eye received topical bimatoprost 0.03% once daily. Rescue topical IOP-lowering medication or single repeat administration with implant was permitted. The primary endpoint was IOP change from baseline. Safety measures included adverse events (AEs). Results: At month 24, mean IOP reduction from baseline was 7.5, 7.3, 7.3, and 8.9 mmHg in eyes treated with Bimatoprost SR 6, 10, 15, and 20 µg, respectively, versus 8.2 mmHg in pooled fellow eyes; 68, 40, and 28% of pooled study eyes had not been rescued/retreated at months 6, 12, and 24, respectively. AEs in study eyes that occurred ≤ 2 days post-procedure typically were transient. After 2 days post-procedure, overall AE incidence was similar between study and fellow eyes, with some events typically associated with topical prostaglandin analogs having lower incidence in study eyes. Conclusions: Bimatoprost SR showed favorable efficacy and safety profiles up to 24 months, with all evaluated dose strengths demonstrating overall IOP-reducing effects comparable to those of topical bimatoprost. Targeted and sustained delivery of bimatoprost resulted in protracted IOP lowering, suggesting that Bimatoprost SR may represent a transformational new approach to glaucoma therapy.

Funding

This study was sponsored by Allergan plc (Dublin, Ireland). The study sponsor participated in the design of the study, data management, analysis and interpretation, and preparation, review, and approval of the manuscript.

History

Publication Date

01/02/2020

Journal

Drugs

Volume

80

Issue

2

Pagination

13p. (p. 167-179)

Publisher

Springer

ISSN

0012-6667

Rights Statement

The Author reserves all moral rights over the deposited text and must be credited if any re-use occurs. Documents deposited in OPAL are the Open Access versions of outputs published elsewhere. Changes resulting from the publishing process may therefore not be reflected in this document. The final published version may be obtained via the publisher’s DOI. Please note that additional copyright and access restrictions may apply to the published version.