Cargando…

Safety of Fixed-Combination Bimatoprost 0.03%/Timolol 0.5% Ophthalmic Solution at 6 Months in Chinese Patients with Open-Angle Glaucoma or Ocular Hypertension

INTRODUCTION: Fixed-combination bimatoprost 0.03%/timolol 0.5% ophthalmic solution (FCBT; Ganfort(®), Allergan, an AbbVie company) effectively reduces intraocular pressure (IOP) via complementary mechanisms of action of the agents, but long-term (> 12 weeks) safety evaluations of FCBT remain limi...

Descripción completa

Detalles Bibliográficos
Autores principales: Sun, Xinghuai, Yao, Ke, Liu, Qinghuai, Zhang, Hong, Xing, Xiaoli, Fang, Aiwu, Duan, Xuanchu, Yu, Minbin, Chen, Michelle Y., Yang, Jingyuan, Goodkin, Margot L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9834455/
https://www.ncbi.nlm.nih.gov/pubmed/36370233
http://dx.doi.org/10.1007/s40123-022-00593-w
_version_ 1784868463353790464
author Sun, Xinghuai
Yao, Ke
Liu, Qinghuai
Zhang, Hong
Xing, Xiaoli
Fang, Aiwu
Duan, Xuanchu
Yu, Minbin
Chen, Michelle Y.
Yang, Jingyuan
Goodkin, Margot L.
author_facet Sun, Xinghuai
Yao, Ke
Liu, Qinghuai
Zhang, Hong
Xing, Xiaoli
Fang, Aiwu
Duan, Xuanchu
Yu, Minbin
Chen, Michelle Y.
Yang, Jingyuan
Goodkin, Margot L.
author_sort Sun, Xinghuai
collection PubMed
description INTRODUCTION: Fixed-combination bimatoprost 0.03%/timolol 0.5% ophthalmic solution (FCBT; Ganfort(®), Allergan, an AbbVie company) effectively reduces intraocular pressure (IOP) via complementary mechanisms of action of the agents, but long-term (> 12 weeks) safety evaluations of FCBT remain limited. FCBT safety is evaluated herein, with particular focus on hyperemia and eyelash growth, at 24 weeks in Chinese patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: In this multicenter, open-label, noncomparative, phase 4 study conducted in China, patients diagnosed with OAG or OHT having insufficient response to β-blocker- or prostaglandin analogue/prostamide (PGA)-based IOP-lowering monotherapy in one or both eyes were switched from their current IOP-lowering treatment to FCBT (one drop per eye every evening) without prior washout. Assessment visits were scheduled at baseline and weeks 4, 12, and 24 (or study exit). The primary outcome measure was adverse event (AE) incidence through 24 weeks. RESULTS: Of 725 patients enrolled, 632 (87.2%) completed the study; 93 (12.8%) patients discontinued, including 29 (4.0%) due to AEs. Of 1326 FCBT-treated eyes (total), 594 (44.8%) experienced ≥ 1 ocular treatment-related AE during the study. Conjunctival hyperemia (the most common AE overall) and eyelash growth were reported in 269 (20.3%) and 54 (4.1%) FCBT-treated eyes, respectively. The incidence of other known PGA-related AEs (including blepharal pigmentation and erythema of eyelid) was < 10% each. Most conjunctival hyperemia reports were mild in severity (214/259; 82.6%) and only 1/259 (0.4%) was severe. Similarly, most cases of eyelash growth were mild (46/52; 88.5%); none were severe. One (< 0.1%) FCBT-treated eye had a serious ocular AE (OAG) considered FCBT-related. CONCLUSIONS: The frequency and severity of FCBT-related AEs, including conjunctival hyperemia and eyelash growth, are consistent with previously published findings. No new safety concerns were raised. This prospective study reaffirms that once-daily FCBT is a safe and well-tolerated therapy for OAG and OHT. CLINICALTRIALS.GOV IDENTIFIER: NCT02571712.
format Online
Article
Text
id pubmed-9834455
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher Springer Healthcare
record_format MEDLINE/PubMed
spelling pubmed-98344552023-01-13 Safety of Fixed-Combination Bimatoprost 0.03%/Timolol 0.5% Ophthalmic Solution at 6 Months in Chinese Patients with Open-Angle Glaucoma or Ocular Hypertension Sun, Xinghuai Yao, Ke Liu, Qinghuai Zhang, Hong Xing, Xiaoli Fang, Aiwu Duan, Xuanchu Yu, Minbin Chen, Michelle Y. Yang, Jingyuan Goodkin, Margot L. Ophthalmol Ther Original Research INTRODUCTION: Fixed-combination bimatoprost 0.03%/timolol 0.5% ophthalmic solution (FCBT; Ganfort(®), Allergan, an AbbVie company) effectively reduces intraocular pressure (IOP) via complementary mechanisms of action of the agents, but long-term (> 12 weeks) safety evaluations of FCBT remain limited. FCBT safety is evaluated herein, with particular focus on hyperemia and eyelash growth, at 24 weeks in Chinese patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: In this multicenter, open-label, noncomparative, phase 4 study conducted in China, patients diagnosed with OAG or OHT having insufficient response to β-blocker- or prostaglandin analogue/prostamide (PGA)-based IOP-lowering monotherapy in one or both eyes were switched from their current IOP-lowering treatment to FCBT (one drop per eye every evening) without prior washout. Assessment visits were scheduled at baseline and weeks 4, 12, and 24 (or study exit). The primary outcome measure was adverse event (AE) incidence through 24 weeks. RESULTS: Of 725 patients enrolled, 632 (87.2%) completed the study; 93 (12.8%) patients discontinued, including 29 (4.0%) due to AEs. Of 1326 FCBT-treated eyes (total), 594 (44.8%) experienced ≥ 1 ocular treatment-related AE during the study. Conjunctival hyperemia (the most common AE overall) and eyelash growth were reported in 269 (20.3%) and 54 (4.1%) FCBT-treated eyes, respectively. The incidence of other known PGA-related AEs (including blepharal pigmentation and erythema of eyelid) was < 10% each. Most conjunctival hyperemia reports were mild in severity (214/259; 82.6%) and only 1/259 (0.4%) was severe. Similarly, most cases of eyelash growth were mild (46/52; 88.5%); none were severe. One (< 0.1%) FCBT-treated eye had a serious ocular AE (OAG) considered FCBT-related. CONCLUSIONS: The frequency and severity of FCBT-related AEs, including conjunctival hyperemia and eyelash growth, are consistent with previously published findings. No new safety concerns were raised. This prospective study reaffirms that once-daily FCBT is a safe and well-tolerated therapy for OAG and OHT. CLINICALTRIALS.GOV IDENTIFIER: NCT02571712. Springer Healthcare 2022-11-12 2023-02 /pmc/articles/PMC9834455/ /pubmed/36370233 http://dx.doi.org/10.1007/s40123-022-00593-w Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Sun, Xinghuai
Yao, Ke
Liu, Qinghuai
Zhang, Hong
Xing, Xiaoli
Fang, Aiwu
Duan, Xuanchu
Yu, Minbin
Chen, Michelle Y.
Yang, Jingyuan
Goodkin, Margot L.
Safety of Fixed-Combination Bimatoprost 0.03%/Timolol 0.5% Ophthalmic Solution at 6 Months in Chinese Patients with Open-Angle Glaucoma or Ocular Hypertension
title Safety of Fixed-Combination Bimatoprost 0.03%/Timolol 0.5% Ophthalmic Solution at 6 Months in Chinese Patients with Open-Angle Glaucoma or Ocular Hypertension
title_full Safety of Fixed-Combination Bimatoprost 0.03%/Timolol 0.5% Ophthalmic Solution at 6 Months in Chinese Patients with Open-Angle Glaucoma or Ocular Hypertension
title_fullStr Safety of Fixed-Combination Bimatoprost 0.03%/Timolol 0.5% Ophthalmic Solution at 6 Months in Chinese Patients with Open-Angle Glaucoma or Ocular Hypertension
title_full_unstemmed Safety of Fixed-Combination Bimatoprost 0.03%/Timolol 0.5% Ophthalmic Solution at 6 Months in Chinese Patients with Open-Angle Glaucoma or Ocular Hypertension
title_short Safety of Fixed-Combination Bimatoprost 0.03%/Timolol 0.5% Ophthalmic Solution at 6 Months in Chinese Patients with Open-Angle Glaucoma or Ocular Hypertension
title_sort safety of fixed-combination bimatoprost 0.03%/timolol 0.5% ophthalmic solution at 6 months in chinese patients with open-angle glaucoma or ocular hypertension
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9834455/
https://www.ncbi.nlm.nih.gov/pubmed/36370233
http://dx.doi.org/10.1007/s40123-022-00593-w
work_keys_str_mv AT sunxinghuai safetyoffixedcombinationbimatoprost003timolol05ophthalmicsolutionat6monthsinchinesepatientswithopenangleglaucomaorocularhypertension
AT yaoke safetyoffixedcombinationbimatoprost003timolol05ophthalmicsolutionat6monthsinchinesepatientswithopenangleglaucomaorocularhypertension
AT liuqinghuai safetyoffixedcombinationbimatoprost003timolol05ophthalmicsolutionat6monthsinchinesepatientswithopenangleglaucomaorocularhypertension
AT zhanghong safetyoffixedcombinationbimatoprost003timolol05ophthalmicsolutionat6monthsinchinesepatientswithopenangleglaucomaorocularhypertension
AT xingxiaoli safetyoffixedcombinationbimatoprost003timolol05ophthalmicsolutionat6monthsinchinesepatientswithopenangleglaucomaorocularhypertension
AT fangaiwu safetyoffixedcombinationbimatoprost003timolol05ophthalmicsolutionat6monthsinchinesepatientswithopenangleglaucomaorocularhypertension
AT duanxuanchu safetyoffixedcombinationbimatoprost003timolol05ophthalmicsolutionat6monthsinchinesepatientswithopenangleglaucomaorocularhypertension
AT yuminbin safetyoffixedcombinationbimatoprost003timolol05ophthalmicsolutionat6monthsinchinesepatientswithopenangleglaucomaorocularhypertension
AT chenmichelley safetyoffixedcombinationbimatoprost003timolol05ophthalmicsolutionat6monthsinchinesepatientswithopenangleglaucomaorocularhypertension
AT yangjingyuan safetyoffixedcombinationbimatoprost003timolol05ophthalmicsolutionat6monthsinchinesepatientswithopenangleglaucomaorocularhypertension
AT goodkinmargotl safetyoffixedcombinationbimatoprost003timolol05ophthalmicsolutionat6monthsinchinesepatientswithopenangleglaucomaorocularhypertension