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Clinical Trial
. 2025 Apr;85(4):557-570.
doi: 10.1007/s40265-025-02154-4. Epub 2025 Feb 22.

Safety and Longevity of Intraocular Pressure Control After Bimatoprost Implant Administration: Interim Analysis of a Phase 3b Clinical Trial (TRITON)

Steven M Silverstein  1 , Francesco Oddone  2 , Miriam Kolko  3 , Christian K Brinkmann  4 , William C Christie  5 , Amanda K Bicket  6 , Petrus N J Gous  7 , Jan Luebke  8   9 , Jyotsna Maram  10 , Ashley Nguyen  10 , E Randy Craven  10 , Yongjia Pu  10 , Jenny Jiao  10 , Marina Bejanian  10 , Michael R Robinson  10 ; TRITON Study Group
Collaborators, Affiliations
Clinical Trial

Safety and Longevity of Intraocular Pressure Control After Bimatoprost Implant Administration: Interim Analysis of a Phase 3b Clinical Trial (TRITON)

Steven M Silverstein et al. Drugs. 2025 Apr.

Abstract

Background: Bimatoprost implant 10 µg is an intracameral, biodegradable implant that slowly releases bimatoprost to lower intraocular pressure (IOP). This study was designed to evaluate safety and the duration of the IOP-lowering effect after single and as-needed repeat administration of the bimatoprost implant in patients with open-angle glaucoma (OAG) and ocular hypertension (OHT).

Patients and methods: This study is an interim analysis of an ongoing, prospective, open-label, multicenter study in patients with OAG or OHT who are inadequately managed with topical IOP-lowering medication for reasons other than efficacy. IOP-lowering rescue treatment is allowed if implant retreatment criteria are not met. The primary endpoint is time to retreatment/rescue after the initial implant administration analyzed with the Kaplan-Meier method. Key safety measures include treatment-emergent adverse events (TEAEs) and reading-center evaluation of central corneal endothelial cell density (CECD). Analysis of data collected through 15 September 2023 focused on outcomes after a single or two implants.

Results: In total, 441 patients received the 10-µg bimatoprost implant in the study eye on day 1 (cycle 1), 179 patients received a second administration (cycle 2), and 378 patients had at least 12 months of follow-up data available. The median time (95% confidence interval) from the first administration to a second administration or rescue was 392 (369, 485) days; the probability of not requiring retreatment or rescue by day 360 was 57.5%. A second implant administration similarly provided a long duration of IOP control. The baseline mean (standard error, SE) IOP was 25.6 (0.14) mmHg; the mean (SE) change from baseline IOP in unrescued eyes after a single administration was - 7.5 (0.21) mmHg at week 24 and - 6.4 (0.28) mmHg at month 12. Conjunctival hyperemia, typically associated with the administration procedure, was the most common ocular TEAE (cycle 1, 14.3%; cycle 2, 12.8%). Mean (SE) percentage change in CECD from baseline at 12 months after administration was - 4.3 (0.81)% in cycle 1 and - 8.5 (2.22)% in cycle 2. The cycle 1 implant was no longer visible or ≤ 25% of initial size in 66.3% and 94.3% of study eyes at months 12 and 24, respectively.

Conclusions: In this interim analysis based on available data, the IOP-lowering effect of the initial administration of the 10-µg bimatoprost implant was well maintained for > 1 year in most patients. Results after a second administration were comparable. The safety profile of initial and repeat administration was acceptable.

Trial registry: ClinicalTrials.gov identifier NCT03850782; registered 20 February 2019.

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Conflict of interest statement

Declarations. Funding: Allergan (prior to its acquisition by AbbVie) and/or AbbVie funded this study and participated in the study design, research, analysis, data collection, interpretation of data, reviewing, and approval of the publication. Conflict of interest: Amanda K. Bicket is a consultant for W.L. Gore and Associates, Inc. Christian Brinkmann has received financial compensation from AbbVie, Afidera, Appelis, Bayer, Heidelberg Engineering, Novartis, Santen, Teleon Surgical, and Théa Laboratories. William C. Christie is a consultant for Allergan (an AbbVie company). Petrus N.J. Gous has no financial interests to disclose. Miriam Kolko is a speaker for AbbVie, Santen, Théa Laboratories, and Topcon; and sits on advisory boards for AbbVie, Santen, and Théa Laboratories. Jan Luebke is a speaker for AbbVie, Alcon, Glaukos, iStar Medical, Santen, and Théa Laboratories and sits on advisory boards for AbbVie and Santen. Francesco Oddone is a speaker for AbbVie, Omikron Italia, Santen, Sifi, and Theà; sits on advisory boards for AbbVie, Dompè, and Santen; and has received research grants from AbbVie, Santen, and Omikron Italia. Steven M. Silverstein has no disclosures beyond participation in this clinical study. Marina Bejanian, E. Randy Craven, Jenny Jiao, Jyotsna Maram, Ashley Nguyen, Yongjia Pu, and Michael R. Robinson are employees of AbbVie and may hold AbbVie stock. Ethics approval: Institutional review board or independent ethics committee approval was obtained at each site before the study began, and the study was performed in compliance with Good Clinical Practice, the principles of the Declaration of Helsinki, and applicable laws and regulations (ClinicalTrials.gov registration number NCT03850782). Consent for participation: All patients in this study provided written informed consent before undergoing any study-related procedure. Data availability: 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 (e.g., 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 USA 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/ . Code availability: Not applicable. Author contributions: Study design: M.B. and A.N.; data collection: A.K.B., C.K.B., W.C.C., P.N.J.G., J.L., M.K., F.O., and S.M.S.; statistical analysis: J.J. and Y.P.; data interpretation: M.B., A.K.B., C.K.B., W.C.C., P.N.J.G., J.J., J.L., M.K., J.M., A.N., F.O., Y.P., and S.M.S.; drafting, revision, and approval of the manuscript: M.B., A.K.B., C.K.B., W.C.C., P.N.J.G., J.J., J.L., M.K., J.M., A.N., F.O., Y.P., and S.M.S.

Figures

Fig. 1
Fig. 1
Study schematic. After bimatoprost implant readministration in the study eye, patients were seen at visits 1 day and 4, 8, 12, and 16 weeks after the readministration, then returned to the original study visit schedule. The recommended time for fellow eye administration in eyes that met eligibility criteria was 1–3 weeks after implant readministration in the study eye; a safety visit was scheduled for the day after the fellow eye administration visit. BL baseline, PRN pro re nata, SOC standard-of-care
Fig. 2
Fig. 2
Longevity of IOP management without retreatment or rescue after a single bimatoprost implant administration in the study eye. IOP intraocular pressure
Fig. 3
Fig. 3
Mean change in IOP from baseline in unrescued study eyes after a single bimatoprost implant administration. Error bars indicate the standard error of the mean. IOP intraocular pressure
Fig. 4
Fig. 4
Mean IOP change from the last visit (generally SOC-medicated) before a single implant administration in eligible fellow eyes. Fellow eyes received SOC treatment that was stopped at least 1 day before the implant administration. The baseline (time 0) measurement shown was the last non-missing assessment at a scheduled visit prior to the implant administration. Error bars indicate the standard error of the mean. IOP intraocular pressure, SOC standard-of-care
Fig. 5
Fig. 5
Mean CECD over time in study eyes treated with a single or multiple implants and single implant-treated fellow eyes based on central reading center evaluation of specular microscopy. Error bars show the standard error of the mean. CECD central corneal endothelial cell density
See this image and copyright information in PMC

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