July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Comparison of the change in intraocular pressure with a fixed-dose combination of brinzolamide 1% and brimonidine 0.2% vs brinzolamide or brimonidine alone in patients with open-angle glaucoma or ocular hypertension: A post hoc, pooled, phase 3 analysis
Author Affiliations & Notes
  • Xiangyi Meng
    Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, United States
  • Kenneth N Sall
    Sall Research Medical Center, Artesia, California, United States
  • David Wirta
    Aesthetic Eye Care Institute & Eye Research Foundation, Newport Beach, California, United States
  • Steve Burmaster
    Novartis Pharmaceuticals Corporation, Fort Worth, Texas, United States
  • Qing Cai
    Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, United States
  • Jason Bacharach
    North Bay Eye Associates Inc., Petaluma, California, United States
  • Footnotes
    Commercial Relationships   Xiangyi Meng, Novartis Pharmaceuticals Corporation (E); Kenneth Sall, Aerie (C), Allergan (C), ForSight (C), ForSight VISION5 (F), Hovione (C), Kala (C), Lexitas (C), Novartis (C); David Wirta, Aerie (F), Alcon (F), Allergan (F), Kala (F), Novartis (F), Shire (F); Steve Burmaster, Novartis Pharmaceuticals Corporation (E); Qing Cai, Novartis Pharmaceuticals Corporation (E); Jason Bacharach, Aerie Pharmaceuticals, Inc. (C), Alcon (C), Allergan (C), Bausch and Lomb (C), Glaukos (C), Injectsense (I)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 2715. doi:
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      Xiangyi Meng, Kenneth N Sall, David Wirta, Steve Burmaster, Qing Cai, Jason Bacharach; Comparison of the change in intraocular pressure with a fixed-dose combination of brinzolamide 1% and brimonidine 0.2% vs brinzolamide or brimonidine alone in patients with open-angle glaucoma or ocular hypertension: A post hoc, pooled, phase 3 analysis. Invest. Ophthalmol. Vis. Sci. 2018;59(9):2715.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To compare the change from Baseline in area under curve (AUC) of intraocular pressure (IOP) over 3 months of topical ocular therapy with a fixed-dose combination of brinzolamide 1% and brimonidine 0.2% (Simbrinza; BBFC) vs brinzolamide 1% (Brinz) or brimonidine 0.2% (Brim) alone, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Methods : A post hoc analysis of pooled data from two pivotal phase 3 trials (NCT01297517, NCT01297920) that compared BBFC vs Brinz or Brim, given three times daily for 3 months in patients with OAG or OHT. Change from Baseline in AUC of IOP (mmHg*hour) was assessed at Week 2, Week 6, and Month 3 in the morning (8 AM and 10 AM), afternoon (3 PM and 5 PM), and morning and afternoon (AM+PM). Pairwise comparisons were based on the least squares means derived from a statistical model accounting for correlated IOP measurements within patient.

Results : Demographic and Baseline characteristics were generally well balanced across the treatment groups. Mean age of the intent-to-treat population (N=1328) was 64.7 years, and 58.4% were female. At Month 3, the mean change from Baseline in AUC of IOP was significantly (P<0.0001) greater with BBFC compared with Brinz or Brim during AM, PM, and AM+PM (Figure 1 and Table 1). Overall, 484/1350 patients (35.9% of the safety population) experienced an adverse event (AE), regardless of the study drug relationship (BBFC: 175/435 [40.2%]; Brinz: 158/460 [34.3%]; Brim: 151/455 [33.2%]). The most common AEs (≥3% in any group) were blurred vision, eye irritation, dysgeusia, dry mouth, ocular hyperemia, conjunctivitis, and eye allergy.

Conclusions : Over 3 months, fixed-dose combination brinzolamide 1%/brimonidine 0.2% demonstrated a greater reduction in IOP compared with brinzolamide or brimonidine alone, in patients with OAG or OHT.

Study sponsored by Alcon, an affiliate of Novartis.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

 

Figure 1. Change from Baseline in IOP AUC (mmHg*hour) by Visit (intent-to-treat population)

Figure 1. Change from Baseline in IOP AUC (mmHg*hour) by Visit (intent-to-treat population)

 

Table 1. Treatment comparisons in terms of change from Baseline in IOP AUC (mmHg*hour) at Month 3

Table 1. Treatment comparisons in terms of change from Baseline in IOP AUC (mmHg*hour) at Month 3

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