Bromfenac Ophthalmic Solution 0.07% Versus Nepafenac Ophthalmic Suspension 0.3% for Post-Cataract Surgery Inflammation: A Pilot Study of Identical Dosing Regimens with Pre-Surgical "Pulse" Dose

Steven M Silverstein, Steven M Silverstein

Abstract

Introduction: This small pilot study is the first direct comparison of the currently marketed formulations of bromfenac (0.07% solution) and nepafenac (0.3% suspension) using identical dosing regimens and including an extra pre-surgical "pulse" dose in patients undergoing cataract surgery.

Methods: Adults scheduled for unilateral phacoemulsification with intraocular lens implantation were randomly assigned to bromfenac 0.07% or nepafenac 0.3%, each given once-daily 1 day prior to surgery, on the day of surgery plus an extra dose 1 h before surgery, and for 14 days after surgery. Assessments included summed ocular inflammation score (SOIS), visual acuity (VA), and retinal thickness measured via optical coherence tomography.

Results: The study population included 49 patients (bromfenac, n = 24; nepafenac, n = 25). The percentage of patients with a SOIS = 0 (no cells or flare) at post-surgical day 15 (primary efficacy endpoint) was statistically similar between the bromfenac (57.1%) and nepafenac (50.0%) treatment groups (intent-to-treat with last observation carried forward) (P = 0.6318). The proportions of patients with an SOIS of 0 at days 3 and 8 were significantly (P < 0.05) higher in the bromfenac group (23.8 and 52.4%, respectively) versus the nepafenac group (0.0 and 20.8%, respectively). Visual acuity was similar between groups at each study visit, as were mean retinal thickness and change from baseline in retinal thickness. Rescue medication (typically difluprednate) was given on or before day 15 to 13 patients in each treatment group (bromfenac, 54.2%; nepafenac, 52.0%). There were no adverse events considered to be related to either treatment.

Conclusions: The results of this small pilot study suggest that once-daily bromfenac 0.07% produces similar benefits with regard to postsurgical inflammation, VA, and retinal thickness as once-daily nepafenac 0.3%, and possibly has a faster onset of anti-inflammatory action, when compared using identical dosing regimens.

Funding: Bausch & Lomb Incorporated.

Trial registration: NCT03886779.

Keywords: Bromfenac; Cataract surgery; Nepafenac.

Figures

Fig. 1
Fig. 1
Flow chart of patient disposition. aScreen failures included: epiretinal membranes (n = 2); bleeding due to diabetes (n = 1); macular edema (n = 1); intraocular pressure > 22 mmHg (n = 1); severe uncontrolled anemia (n = 1); best corrected visual acuity worse than 20/200 (n = 1). bPatients received pre-surgical doses of study drug and were included in safety evaluations. ITT Intent-to-treat population
Fig. 2
Fig. 2
Percentage of patients with a summed ocular inflammation score (SOIS) of 0 at day 15 (ITT population with last observation carried forward [LOCF] and based on data as observed)
Fig. 3
Fig. 3
Percentage of patients with a SOIS of 0 at each study visit (ITT population with LOCF). Bars reflect 95% confidence limits. Asterisk indicates P < 0.05 vs. nepafenac

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Source: PubMed

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