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Drugs
Published in: Drugs 2/2020

Open Access 01-02-2020 | Glaucoma | Original Research Article

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

Authors: E. Randy Craven, Thomas Walters, William C. Christie, Douglas G. Day, Richard A. Lewis, Margot L. Goodkin, Michelle Chen, Veronica Wangsadipura, Michael R. Robinson, Marina Bejanian, for the Bimatoprost SR Study Group

Published in: Drugs | Issue 2/2020

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Abstract

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. Clinicaltrials.gov identifier: NCT01157364
Appendix
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Metadata
Title
24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients
Authors
E. Randy Craven
Thomas Walters
William C. Christie
Douglas G. Day
Richard A. Lewis
Margot L. Goodkin
Michelle Chen
Veronica Wangsadipura
Michael R. Robinson
Marina Bejanian
for the Bimatoprost SR Study Group
Publication date
01-02-2020
Publisher
Springer International Publishing
Published in
Drugs / Issue 2/2020
Print ISSN: 0012-6667
Electronic ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-019-01248-0

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