Bromfenac ophthalmic solution for the treatment of postoperative ocular pain and inflammation: safety, efficacy, and patient adherence

Rajpal, Rajesh K.; Ross, Bryan; Rajpal, Sachin; Hoang, K.-G. G.

doi:10.2147/ppa.s46667

Cited by 19 publications

(17 citation statements)

References 41 publications

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“…In particular, our study used bromfenac 0.075% encased in DuraSite, and our efficacy results were similar to others published on bromfenac 0.07% without DuraSite 16,17. However, the bromfenac 0.075% in this trial was able to prevent pain, which has not been established with other formulations of bromfenac.…”

Section: Discussionsupporting

confidence: 86%

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A randomized double-masked study to compare the ocular safety, tolerability, and efficacy of bromfenac 0.075% compared with vehicle in cataract surgery subjects

Hosseini¹,

Walters²,

DaVanzo³

et al. 2016

OPTH

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PurposeThe aim of this study was to evaluate the safety, tolerability, and efficacy of a low-dose version of bromfenac 0.075% in DuraSite® (bromfenac 0.075%) compared with DuraSite® vehicle (vehicle) alone for the treatment of postoperative inflammation and ocular pain after cataract surgery.MethodsA multicenter, double-masked, vehicle-controlled, parallel-group clinical trial of 240 subjects randomized in a 2:1 ratio to bromfenac 0.075% or vehicle was conducted. Subjects were dosed BID beginning 1 day before the cataract surgery, the day of surgery, and 14 days after surgery. A slit lamp biomicroscopy examination was performed to evaluate the signs of inflammation, including anterior chamber cells (ACC) and anterior chamber flare (ACF). The primary efficacy variable was the proportion of subjects with an ACC grade of 0 at Day 15. Secondary efficacy endpoints included the proportion of subjects who achieved a pain score of 0 at each postsurgical visual analog scale (VAS) assessment and the proportion of subjects with an ACF grade of 0 at Day 15.ResultsAt Day 15, proportionally more subjects in the bromfenac 0.075% group than in the vehicle group had an ACC grade of 0 (57.1% vs 18.8%, respectively; P<0.001). At each of the postsurgical time points (Days 1, 8, 15, and 29), proportionally more bromfenac 0.075%-treated subjects (76.8%, 90.5%, 92.9%, and 85.1%, respectively) had no pain (a VAS score of 0) compared with the vehicle-treated subjects (48.2%, 38.8%, 42.4%, and 47.1%, respectively), and at each time point, these differences in proportions were statistically significant (P<0.001). More subjects in the bromfenac 0.075% group had complete ACF resolution (151/167; 90.4%) compared to those in the vehicle group (54/85; 63.5%). There were no new safety signals reported.ConclusionBromfenac 0.075% in DuraSite is safe, well tolerated, and effective at reducing inflammation and preventing pain associated with cataract surgery.

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Section: Discussionsupporting

confidence: 86%

“…Our results add to the recent literature about the analgesic effects of bromfenac postcataract surgery 14–17. In particular, our study used bromfenac 0.075% encased in DuraSite, and our efficacy results were similar to others published on bromfenac 0.07% without DuraSite 16,17.…”

Section: Discussionsupporting

confidence: 86%

A randomized double-masked study to compare the ocular safety, tolerability, and efficacy of bromfenac 0.075% compared with vehicle in cataract surgery subjects

Hosseini¹,

Walters²,

DaVanzo³

et al. 2016

OPTH

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“…Postoperative inflammation and pain following cataract surgery are routinely managed with topical ophthalmic corticosteroids and/or nonsteroidal anti-inflammatory drugs (NSAIDs) [2,3]. In order to be clinically effective, topical ophthalmic NSAIDs must be capable of penetrating the affected tissues and remaining within those tissues at sufficient levels throughout the dosing interval [3].…”

Section: Introductionmentioning

confidence: 99%

“…The NSAID bromfenac has previously been formulated as a 0.09 % ophthalmic solution (hereafter referred to as bromfenac 0.09 %) with a pH of 8.3 [6]. A formulation of bromfenac with a pH of 7.8 has recently been developed, permitting a reduction in the concentration of the active ingredient to 0.07 % [3]. This article reviews pharmacological, therapeutic efficacy and tolerability data relevant to the use of bromfenac ophthalmic solution 0.07 % (hereafter referred to as bromfenac 0.07 %) [Prolensa Ò ; Bausch & Lomb Inc.] for the management of postoperative inflammation and pain following cataract surgery.…”

Section: Introductionmentioning

confidence: 99%

Bromfenac Ophthalmic Solution 0.07 %: A Review of Its Use After Cataract Surgery

Hoy

2015

Clin Drug Investig

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The nonsteroidal anti-inflammatory drug bromfenac has recently been reformulated with a lower pH to facilitate a reduction in the concentration of bromfenac (to 0.07%) while ensuring an ocular bioavailability similar to that of the 0.09% formulation. Bromfenac ophthalmic solution 0.07% (hereafter referred to as bromfenac 0.07%) [Prolensa(®)] is a once-daily topical ophthalmic solution available in the USA and Canada for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract surgery. In an integrated analysis of two multicentre, phase III studies, bromfenac 0.07% was significantly more effective than placebo in reducing ocular inflammation and pain. In these studies, bromfenac 0.07% was well tolerated, with significantly lower incidences of adverse events, and adverse events affecting the study eye than with placebo. The most common adverse events in the study eye (eye pain, anterior chamber inflammation, foreign body sensation, photophobia, conjunctival hyperaemia and corneal oedema) occurred in numerically fewer bromfenac 0.07% than placebo recipients. Thus, current evidence suggests once-daily bromfenac 0.07% extends the treatment options currently available for the management of postoperative inflammation and pain following cataract surgery.

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“…Their results showed a significant anti-inflammatory response to bromfenac and they recommended using the drug instead of topical steroids following cataract surgery. Other studies have shown that bromfenac is a favourable drug and a valuable addition to the NSAID armamentarium for the management of CMO [11][12][13].…”

Section: Discussionmentioning

confidence: 99%

Bromfenac as a Second Line Therapy for the Management of Post-Operative Cystoid Macular Oedema

Gupta¹

2015

OCR

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Case 1: A 76-year-old male underwent trabeculectomy with mitomycin C in his right eye. One week later, his visual acuity dropped from LogMAR 0.0 to 0.5 and Spectral Domain (SD) OCT detected signs of CMO. Central Foveal Thickness (CFT) measured 312 μm. Intra-ocular pressures were recorded as 16 mmHg and there were no signs of hypotony. He was already on topical steroids following trabeculectomy and it was decided to add ketorolac QDS to manage CMO. Four weeks later, the patient's visual acuity dropped further to 0.6 and SD-OCT showed further increase in CMO (CFT-409 μm). Ketorolac was stopped and bromfenac 0.09% (Yellox, Bausch & Lomb UK Limited) eye drops twice a day (BD) was substituted. Four weeks later, his vision improved to 0.0 with complete resolution of CMO (CFT-212 μm). At six months follow up, there has been no recurrence of CMO and visual acuity continues to remain 0.0. Case 2: An 82-year-old male underwent routine cataract surgery and developed CMO eight weeks following cataract surgery. His visual acuity dropped from-0.1 to 0.5 (CFT-356 μm). The patient was started

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Bromfenac ophthalmic solution for the treatment of postoperative ocular pain and inflammation: safety, efficacy, and patient adherence

Cited by 19 publications

References 41 publications

A randomized double-masked study to compare the ocular safety, tolerability, and efficacy of bromfenac 0.075% compared with vehicle in cataract surgery subjects

A randomized double-masked study to compare the ocular safety, tolerability, and efficacy of bromfenac 0.075% compared with vehicle in cataract surgery subjects

Bromfenac Ophthalmic Solution 0.07 %: A Review of Its Use After Cataract Surgery

Bromfenac as a Second Line Therapy for the Management of Post-Operative Cystoid Macular Oedema

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