Brinzolamide/brimonidine fixed-dose combination bid as an adjunct to a prostaglandin analog for open-angle glaucoma/ocular hypertension

Fotis Topouzis; Ivan Goldberg; Katharina Bell; Andrew J. Tatham; Antonia Ridolfi; Douglas Hubatsch; Marcelo Nicolela; Phillipe Denis; S. Fabian Lerner

doi:10.1177/1120672119878044

Brinzolamide/brimonidine fixed-dose combination bid as an adjunct to a prostaglandin analog for open-angle glaucoma/ocular hypertension

Fotis Topouzis, Ivan Goldberg, Katharina Bell, Andrew J. Tatham, Antonia Ridolfi, Douglas Hubatsch, Marcelo Nicolela, Phillipe Denis, S. Fabian Lerner

Medicine

Research output: Contribution to journal › Article › peer-review

5 Citations (Scopus)

Abstract

Purpose: To evaluate the additive intraocular pressure–lowering effect of twice-daily brinzolamide 1%/brimonidine 0.2% fixed-dose combination (BBFC) as an adjunct to a prostaglandin analog (PGA) in patients with open-angle glaucoma or ocular hypertension insufficiently controlled with PGA monotherapy. Methods: In this Phase 4, double-masked trial, patients aged ⩾18 years, with a mean intraocular pressure of ⩾19 and <32 mm Hg in at least one eye were randomized (1:1) to receive BBFC + PGA (n = 96) or vehicle + PGA (n = 92) for 6 weeks. The primary endpoint was the mean change in diurnal intraocular pressure from baseline (averaged over 09:00 and 11:00 h) at Week 6. Results: The mean diurnal intraocular pressure at baseline was similar in the BBFC + PGA (22.8 mm Hg) and vehicle + PGA (22.9 mm Hg) groups. The least squares mean change in diurnal intraocular pressure from baseline at Week 6 was greater with BBFC + PGA (−5.59 mm Hg (95% confidence interval: −6.2 to −5.0)) than with vehicle + PGA (−2.15 mm Hg (95% confidence interval: −2.7 to −1.6)); the treatment difference was statistically significant in favor of BBFC + PGA (−3.44 mm Hg, (95% confidence interval: −4.2 to −2.7); p < 0.001). Ocular adverse events were reported in 21.1% and 8.7% of patients in the BBFC + PGA and vehicle + PGA groups, respectively. The most frequent ocular adverse event was ocular hyperemia (5.3%) in the BBFC + PGA group and blurred vision (2.2%) in the vehicle + PGA group. Conclusion: BBFC + PGA significantly reduced mean diurnal intraocular pressure than PGA alone in patients with open-angle glaucoma or ocular hypertension. The safety findings with BBFC + PGA were consistent with the known safety profile of the individual medications.

Original language	English
Pages (from-to)	103-111
Number of pages	9
Journal	European Journal of Ophthalmology
Volume	31
Issue number	1
DOIs	https://doi.org/10.1177/1120672119878044
Publication status	Published - Jan 2021

Bibliographical note

Funding Information:
BBFC + PGA significantly reduced mean diurnal intraocular pressure than PGA alone in patients with open-angle glaucoma or ocular hypertension. The safety findings with BBFC + PGA were consistent with the known safety profile of the individual medications. Brinzolamide/brimonidine fixed-dose combination open-angle glaucoma ocular hypertension prostaglandin analogs intraocular pressure reduction novartis foundation https://doi.org/10.13039/100008273 edited-state corrected-proof The medical writing support and editorial assistance during the development of the manuscript was provided by Swati Bhandari (Novartis Healthcare Pvt Ltd, Hyderabad, India). Declaration of conflicting interests The author(s) declared following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: F.T. received grants/research support from Alcon, Pfizer, Novartis, and Thea; consultation fees from Alcon, Bayer, Allergan, Pfizer, and Thea; company sponsored speaker’s bureau: Novartis, Thea, Alcon, Allergan, and Santen. M.N. received research grant from Allergan, Novartis/Alcon, and Aerie; and advisory boards for Allergan and Novartis/Alcon. S.F.L. received grants/research support/speaker from Allergan, Glaukos, Iridex, and Novartis/Alcon. A.J.T. received grants/research support from Novartis, Heidelberg Engineering, Allergan, Inc., Sensimed, and Thea; is a consultant for Allergan, Inc. P.D. is a consultant for Thea, Allergan, Novartis. I.G. is a Advisory Board Member for Novartis, Allergan, and Mundipharma; speaker at supported Symposia for Novartis, Allergan, Mundipharma, and Pfizer. A.R. and D.H. are employees of Novartis. K.B. had nothing to disclose. Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was supported by Novartis Pharma AG, Basel, Switzerland. Trial registration This trial was registered with ClinicalTrials.gov (NCT02419508). Supplemental material Supplemental material for this article is available online.

Funding Information:
The medical writing support and editorial assistance during the development of the manuscript was provided by Swati Bhandari (Novartis Healthcare Pvt Ltd, Hyderabad, India). The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was supported by Novartis Pharma AG, Basel, Switzerland.

Publisher Copyright:
© The Author(s) 2019.

ASJC Scopus Subject Areas

Ophthalmology

PubMed: MeSH publication types

Clinical Trial, Phase IV
Journal Article
Multicenter Study
Randomized Controlled Trial

Access to Document

10.1177/1120672119878044

Cite this

Topouzis, F., Goldberg, I., Bell, K., Tatham, A. J., Ridolfi, A., Hubatsch, D., Nicolela, M., Denis, P., & Lerner, S. F. (2021). Brinzolamide/brimonidine fixed-dose combination bid as an adjunct to a prostaglandin analog for open-angle glaucoma/ocular hypertension. European Journal of Ophthalmology, 31(1), 103-111. https://doi.org/10.1177/1120672119878044

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title = "Brinzolamide/brimonidine fixed-dose combination bid as an adjunct to a prostaglandin analog for open-angle glaucoma/ocular hypertension",

abstract = "Purpose: To evaluate the additive intraocular pressure–lowering effect of twice-daily brinzolamide 1%/brimonidine 0.2% fixed-dose combination (BBFC) as an adjunct to a prostaglandin analog (PGA) in patients with open-angle glaucoma or ocular hypertension insufficiently controlled with PGA monotherapy. Methods: In this Phase 4, double-masked trial, patients aged ⩾18 years, with a mean intraocular pressure of ⩾19 and <32 mm Hg in at least one eye were randomized (1:1) to receive BBFC + PGA (n = 96) or vehicle + PGA (n = 92) for 6 weeks. The primary endpoint was the mean change in diurnal intraocular pressure from baseline (averaged over 09:00 and 11:00 h) at Week 6. Results: The mean diurnal intraocular pressure at baseline was similar in the BBFC + PGA (22.8 mm Hg) and vehicle + PGA (22.9 mm Hg) groups. The least squares mean change in diurnal intraocular pressure from baseline at Week 6 was greater with BBFC + PGA (−5.59 mm Hg (95% confidence interval: −6.2 to −5.0)) than with vehicle + PGA (−2.15 mm Hg (95% confidence interval: −2.7 to −1.6)); the treatment difference was statistically significant in favor of BBFC + PGA (−3.44 mm Hg, (95% confidence interval: −4.2 to −2.7); p < 0.001). Ocular adverse events were reported in 21.1% and 8.7% of patients in the BBFC + PGA and vehicle + PGA groups, respectively. The most frequent ocular adverse event was ocular hyperemia (5.3%) in the BBFC + PGA group and blurred vision (2.2%) in the vehicle + PGA group. Conclusion: BBFC + PGA significantly reduced mean diurnal intraocular pressure than PGA alone in patients with open-angle glaucoma or ocular hypertension. The safety findings with BBFC + PGA were consistent with the known safety profile of the individual medications.",

author = "Fotis Topouzis and Ivan Goldberg and Katharina Bell and Tatham, {Andrew J.} and Antonia Ridolfi and Douglas Hubatsch and Marcelo Nicolela and Phillipe Denis and Lerner, {S. Fabian}",

note = "Funding Information: BBFC + PGA significantly reduced mean diurnal intraocular pressure than PGA alone in patients with open-angle glaucoma or ocular hypertension. The safety findings with BBFC + PGA were consistent with the known safety profile of the individual medications. Brinzolamide/brimonidine fixed-dose combination open-angle glaucoma ocular hypertension prostaglandin analogs intraocular pressure reduction novartis foundation https://doi.org/10.13039/100008273 edited-state corrected-proof The medical writing support and editorial assistance during the development of the manuscript was provided by Swati Bhandari (Novartis Healthcare Pvt Ltd, Hyderabad, India). Declaration of conflicting interests The author(s) declared following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: F.T. received grants/research support from Alcon, Pfizer, Novartis, and Thea; consultation fees from Alcon, Bayer, Allergan, Pfizer, and Thea; company sponsored speaker{\textquoteright}s bureau: Novartis, Thea, Alcon, Allergan, and Santen. M.N. received research grant from Allergan, Novartis/Alcon, and Aerie; and advisory boards for Allergan and Novartis/Alcon. S.F.L. received grants/research support/speaker from Allergan, Glaukos, Iridex, and Novartis/Alcon. A.J.T. received grants/research support from Novartis, Heidelberg Engineering, Allergan, Inc., Sensimed, and Thea; is a consultant for Allergan, Inc. P.D. is a consultant for Thea, Allergan, Novartis. I.G. is a Advisory Board Member for Novartis, Allergan, and Mundipharma; speaker at supported Symposia for Novartis, Allergan, Mundipharma, and Pfizer. A.R. and D.H. are employees of Novartis. K.B. had nothing to disclose. Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was supported by Novartis Pharma AG, Basel, Switzerland. Trial registration This trial was registered with ClinicalTrials.gov (NCT02419508). Supplemental material Supplemental material for this article is available online. Funding Information: The medical writing support and editorial assistance during the development of the manuscript was provided by Swati Bhandari (Novartis Healthcare Pvt Ltd, Hyderabad, India). The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was supported by Novartis Pharma AG, Basel, Switzerland. Publisher Copyright: {\textcopyright} The Author(s) 2019.",

year = "2021",

month = jan,

doi = "10.1177/1120672119878044",

language = "English",

volume = "31",

pages = "103--111",

journal = "European Journal of Ophthalmology",

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TY - JOUR

T1 - Brinzolamide/brimonidine fixed-dose combination bid as an adjunct to a prostaglandin analog for open-angle glaucoma/ocular hypertension

AU - Topouzis, Fotis

AU - Goldberg, Ivan

AU - Bell, Katharina

AU - Tatham, Andrew J.

AU - Ridolfi, Antonia

AU - Hubatsch, Douglas

AU - Nicolela, Marcelo

AU - Denis, Phillipe

AU - Lerner, S. Fabian

N1 - Funding Information: BBFC + PGA significantly reduced mean diurnal intraocular pressure than PGA alone in patients with open-angle glaucoma or ocular hypertension. The safety findings with BBFC + PGA were consistent with the known safety profile of the individual medications. Brinzolamide/brimonidine fixed-dose combination open-angle glaucoma ocular hypertension prostaglandin analogs intraocular pressure reduction novartis foundation https://doi.org/10.13039/100008273 edited-state corrected-proof The medical writing support and editorial assistance during the development of the manuscript was provided by Swati Bhandari (Novartis Healthcare Pvt Ltd, Hyderabad, India). Declaration of conflicting interests The author(s) declared following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: F.T. received grants/research support from Alcon, Pfizer, Novartis, and Thea; consultation fees from Alcon, Bayer, Allergan, Pfizer, and Thea; company sponsored speaker’s bureau: Novartis, Thea, Alcon, Allergan, and Santen. M.N. received research grant from Allergan, Novartis/Alcon, and Aerie; and advisory boards for Allergan and Novartis/Alcon. S.F.L. received grants/research support/speaker from Allergan, Glaukos, Iridex, and Novartis/Alcon. A.J.T. received grants/research support from Novartis, Heidelberg Engineering, Allergan, Inc., Sensimed, and Thea; is a consultant for Allergan, Inc. P.D. is a consultant for Thea, Allergan, Novartis. I.G. is a Advisory Board Member for Novartis, Allergan, and Mundipharma; speaker at supported Symposia for Novartis, Allergan, Mundipharma, and Pfizer. A.R. and D.H. are employees of Novartis. K.B. had nothing to disclose. Funding The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was supported by Novartis Pharma AG, Basel, Switzerland. Trial registration This trial was registered with ClinicalTrials.gov (NCT02419508). Supplemental material Supplemental material for this article is available online. Funding Information: The medical writing support and editorial assistance during the development of the manuscript was provided by Swati Bhandari (Novartis Healthcare Pvt Ltd, Hyderabad, India). The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was supported by Novartis Pharma AG, Basel, Switzerland. Publisher Copyright: © The Author(s) 2019.

PY - 2021/1

Y1 - 2021/1

N2 - Purpose: To evaluate the additive intraocular pressure–lowering effect of twice-daily brinzolamide 1%/brimonidine 0.2% fixed-dose combination (BBFC) as an adjunct to a prostaglandin analog (PGA) in patients with open-angle glaucoma or ocular hypertension insufficiently controlled with PGA monotherapy. Methods: In this Phase 4, double-masked trial, patients aged ⩾18 years, with a mean intraocular pressure of ⩾19 and <32 mm Hg in at least one eye were randomized (1:1) to receive BBFC + PGA (n = 96) or vehicle + PGA (n = 92) for 6 weeks. The primary endpoint was the mean change in diurnal intraocular pressure from baseline (averaged over 09:00 and 11:00 h) at Week 6. Results: The mean diurnal intraocular pressure at baseline was similar in the BBFC + PGA (22.8 mm Hg) and vehicle + PGA (22.9 mm Hg) groups. The least squares mean change in diurnal intraocular pressure from baseline at Week 6 was greater with BBFC + PGA (−5.59 mm Hg (95% confidence interval: −6.2 to −5.0)) than with vehicle + PGA (−2.15 mm Hg (95% confidence interval: −2.7 to −1.6)); the treatment difference was statistically significant in favor of BBFC + PGA (−3.44 mm Hg, (95% confidence interval: −4.2 to −2.7); p < 0.001). Ocular adverse events were reported in 21.1% and 8.7% of patients in the BBFC + PGA and vehicle + PGA groups, respectively. The most frequent ocular adverse event was ocular hyperemia (5.3%) in the BBFC + PGA group and blurred vision (2.2%) in the vehicle + PGA group. Conclusion: BBFC + PGA significantly reduced mean diurnal intraocular pressure than PGA alone in patients with open-angle glaucoma or ocular hypertension. The safety findings with BBFC + PGA were consistent with the known safety profile of the individual medications.

AB - Purpose: To evaluate the additive intraocular pressure–lowering effect of twice-daily brinzolamide 1%/brimonidine 0.2% fixed-dose combination (BBFC) as an adjunct to a prostaglandin analog (PGA) in patients with open-angle glaucoma or ocular hypertension insufficiently controlled with PGA monotherapy. Methods: In this Phase 4, double-masked trial, patients aged ⩾18 years, with a mean intraocular pressure of ⩾19 and <32 mm Hg in at least one eye were randomized (1:1) to receive BBFC + PGA (n = 96) or vehicle + PGA (n = 92) for 6 weeks. The primary endpoint was the mean change in diurnal intraocular pressure from baseline (averaged over 09:00 and 11:00 h) at Week 6. Results: The mean diurnal intraocular pressure at baseline was similar in the BBFC + PGA (22.8 mm Hg) and vehicle + PGA (22.9 mm Hg) groups. The least squares mean change in diurnal intraocular pressure from baseline at Week 6 was greater with BBFC + PGA (−5.59 mm Hg (95% confidence interval: −6.2 to −5.0)) than with vehicle + PGA (−2.15 mm Hg (95% confidence interval: −2.7 to −1.6)); the treatment difference was statistically significant in favor of BBFC + PGA (−3.44 mm Hg, (95% confidence interval: −4.2 to −2.7); p < 0.001). Ocular adverse events were reported in 21.1% and 8.7% of patients in the BBFC + PGA and vehicle + PGA groups, respectively. The most frequent ocular adverse event was ocular hyperemia (5.3%) in the BBFC + PGA group and blurred vision (2.2%) in the vehicle + PGA group. Conclusion: BBFC + PGA significantly reduced mean diurnal intraocular pressure than PGA alone in patients with open-angle glaucoma or ocular hypertension. The safety findings with BBFC + PGA were consistent with the known safety profile of the individual medications.

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Brinzolamide/brimonidine fixed-dose combination bid as an adjunct to a prostaglandin analog for open-angle glaucoma/ocular hypertension

Abstract

Bibliographical note

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PubMed: MeSH publication types

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