Real-World Study of the Effectiveness and Safety of Intracameral Bimatoprost Implant in a Clinical Setting in the United States

Abstract

Purpose

A sustained-release, biodegradable, intracameral 10-µg bimatoprost implant (Durysta) is approved for single administration per eye to lower intraocular pressure (IOP) in open-angle glaucoma (OAG) and ocular hypertension (OHT). The purpose of this study was to evaluate the IOP-lowering effectiveness and safety of a single implant administration per eye in patients with OAG or OHT in a real-world clinical setting.

Methods

This was a retrospective, single-site study involving 105 consecutive adult patients with OAG or OHT treated with the bimatoprost implant in 1 or both eyes in routine clinical practice. Available medical records of the patients for 12 months or longer after the initial implant administration were reviewed, and data including IOP, IOP-lowering medication and procedure use, and safety outcomes were collected and analyzed. The analysis used ranges of follow-up because of the real-world setting.

Results

The study included 197 eyes (85.3% diagnosed with OAG, 94.9% pseudophakic, and 83.8% with angle grade 4). IOP reduction was observed through 1 year after the bimatoprost implant administration. Mean IOP was 16.6 mmHg at baseline and 13.3 mmHg at 11–13 months, with the mean number of topical IOP-lowering medications used reduced from 1.4 at baseline to 0.2 at 11–13 months. IOP and IOP-lowering medication use were similarly reduced in eyes treated with both selective laser trabeculoplasty (SLT) and bimatoprost implant (including 66 eyes with their last SLT before implant administration and 28 eyes with their last SLT after implant administration). There were no cases of treatment-emergent corneal edema after bimatoprost implant administration, and no eye required implant removal.

Conclusion

A single bimatoprost implant administration safely and effectively reduced IOP for up to 1 year and decreased the need for topical IOP-lowering medications in eyes with OAG or OHT with or without previous or subsequent SLT.

Keywords:

• biodegradable implant
• drug delivery system
• intraocular injection
• prostaglandin analog

Abbreviations

IOP, intraocular pressure; MIGS, microincisional glaucoma surgery; OAG, open-angle glaucoma; OHT, ocular hypertension; PGA, prostaglandin analog/prostamide; SD, standard deviation; SLT, selective laser trabeculoplasty.

Data Sharing Statement

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual, and trial-level data (analysis data sets), as well as other information (eg, protocols, clinical study reports, or analysis plans), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. These clinical trial data can be requested by any qualified researchers who engage in rigorous, independent, scientific research, and will be provided following review and approval of a research proposal, Statistical Analysis Plan (SAP), and execution of a Data Sharing Agreement (DSA). Data requests can be submitted at any time after approval in the US and Europe and after acceptance of this manuscript for publication. The data will be accessible for 12 months, with possible extensions considered. For more information on the process or to submit a request, visit the following link: https://www.abbvieclinicaltrials.com/hcp/data-sharing/.

Acknowledgments

A contract research organization, iuvo BioScience, LLC (Rush, NY) performed the data analysis. Medical writing assistance was provided to the authors by Evidence Scientific Solutions, Inc (Philadelphia, PA) and funded by AbbVie. All authors had access to relevant data and participated in the drafting, review, and approval of this publication. No honoraria or payments were made for authorship.

Disclosure

Savak Teymoorian is a consultant for Aerie, Alcon, Allergan (an AbbVie company), Bausch + Lomb, Ellex, Glaukos, MDBackline.com, and Omeros; has received research funding from Aerie, Allergan (an AbbVie company), and Bausch + Lomb; and receives royalties from Slack. E Randy Craven and Erica Werts are employees of AbbVie and may hold stock. Lannhi Nguyen has no financial relationships to disclose.

Additional information

Funding

AbbVie funded this study and participated in the study design; data interpretation; and the preparation, review, and approval of the manuscript.