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Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies
PURPOSE: To evaluate the time course of biodegradation of an intracameral, biodegradable, sustained-release bimatoprost implant that lowers intraocular pressure without the need for daily eye drops. METHODS: In 2 identically designed, randomized, phase 3 clinical trials, adults with open-angle glauc...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Mary Ann Liebert, Inc., publishers
2023
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9885540/ https://www.ncbi.nlm.nih.gov/pubmed/36378864 http://dx.doi.org/10.1089/jop.2022.0137 |
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author | Weinreb, Robert N. Bacharach, Jason Brubaker, Jacob W. Medeiros, Felipe A. Bejanian, Marina Bernstein, Paula Robinson, Michael R. |
author_facet | Weinreb, Robert N. Bacharach, Jason Brubaker, Jacob W. Medeiros, Felipe A. Bejanian, Marina Bernstein, Paula Robinson, Michael R. |
author_sort | Weinreb, Robert N. |
collection | PubMed |
description | PURPOSE: To evaluate the time course of biodegradation of an intracameral, biodegradable, sustained-release bimatoprost implant that lowers intraocular pressure without the need for daily eye drops. METHODS: In 2 identically designed, randomized, phase 3 clinical trials, adults with open-angle glaucoma or ocular hypertension and open iridocorneal angles inferiorly in the study eye were administered 10- or 15-μg bimatoprost implant (day 1 and weeks 16 and 32) or twice-daily topical timolol 0.5%. Implants were assessed on gonioscopy throughout the studies. Investigators reported whether implants were visible, estimated the size of visible implants relative to their initial size at implantation, and reported the implant location. Data for 10-μg implant placed on day 1 were pooled from both studies for analysis. RESULTS: A total of 372 patients received the 10-μg bimatoprost implant. The degree of implant biodegradation at each follow-up time point was variable among patients. The implant frequently swelled during the initial phase of biodegradation from 6 to 28 weeks. Accelerated biodegradation occurred between 31 and 52 weeks, resulting in 82% of implants absent or ≤25% of initial size by 52 weeks. By month 20, 95% of implants had biodegraded to absent or ≤25% of initial size. The implant was predominantly located inferiorly in the iridocorneal angle. CONCLUSIONS: Bimatoprost implant biodegradation in phase 3 studies showed some degree of variability among patients. Clinically significant implant biodegradation was observed in the majority of patients by 12 months. Clinical studies are in progress to further understand implant biodegradation and the ideal timing for implant re-administration. ClinicalTrials.gov NCT02247804; ClinicalTrials.gov NCT02250651. |
format | Online Article Text |
id | pubmed-9885540 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Mary Ann Liebert, Inc., publishers |
record_format | MEDLINE/PubMed |
spelling | pubmed-98855402023-02-01 Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies Weinreb, Robert N. Bacharach, Jason Brubaker, Jacob W. Medeiros, Felipe A. Bejanian, Marina Bernstein, Paula Robinson, Michael R. J Ocul Pharmacol Ther Original Articles PURPOSE: To evaluate the time course of biodegradation of an intracameral, biodegradable, sustained-release bimatoprost implant that lowers intraocular pressure without the need for daily eye drops. METHODS: In 2 identically designed, randomized, phase 3 clinical trials, adults with open-angle glaucoma or ocular hypertension and open iridocorneal angles inferiorly in the study eye were administered 10- or 15-μg bimatoprost implant (day 1 and weeks 16 and 32) or twice-daily topical timolol 0.5%. Implants were assessed on gonioscopy throughout the studies. Investigators reported whether implants were visible, estimated the size of visible implants relative to their initial size at implantation, and reported the implant location. Data for 10-μg implant placed on day 1 were pooled from both studies for analysis. RESULTS: A total of 372 patients received the 10-μg bimatoprost implant. The degree of implant biodegradation at each follow-up time point was variable among patients. The implant frequently swelled during the initial phase of biodegradation from 6 to 28 weeks. Accelerated biodegradation occurred between 31 and 52 weeks, resulting in 82% of implants absent or ≤25% of initial size by 52 weeks. By month 20, 95% of implants had biodegraded to absent or ≤25% of initial size. The implant was predominantly located inferiorly in the iridocorneal angle. CONCLUSIONS: Bimatoprost implant biodegradation in phase 3 studies showed some degree of variability among patients. Clinically significant implant biodegradation was observed in the majority of patients by 12 months. Clinical studies are in progress to further understand implant biodegradation and the ideal timing for implant re-administration. ClinicalTrials.gov NCT02247804; ClinicalTrials.gov NCT02250651. Mary Ann Liebert, Inc., publishers 2023-02-01 2023-01-25 /pmc/articles/PMC9885540/ /pubmed/36378864 http://dx.doi.org/10.1089/jop.2022.0137 Text en © Robert N. Weinreb et al. 2023; Published by Mary Ann Liebert, Inc. https://creativecommons.org/licenses/by/4.0/This Open Access article is distributed under the terms of the Creative Commons License [CC-BY] (http://creativecommons.org/licenses/by/4.0 (https://creativecommons.org/licenses/by/4.0/) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Articles Weinreb, Robert N. Bacharach, Jason Brubaker, Jacob W. Medeiros, Felipe A. Bejanian, Marina Bernstein, Paula Robinson, Michael R. Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies |
title | Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies |
title_full | Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies |
title_fullStr | Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies |
title_full_unstemmed | Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies |
title_short | Bimatoprost Implant Biodegradation in the Phase 3, Randomized, 20-Month ARTEMIS Studies |
title_sort | bimatoprost implant biodegradation in the phase 3, randomized, 20-month artemis studies |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9885540/ https://www.ncbi.nlm.nih.gov/pubmed/36378864 http://dx.doi.org/10.1089/jop.2022.0137 |
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