Bromfenac Ophthalmic Solution 0.07% Dosed Once Daily for Cataract Surgery

Walters, Thomas R.; Goldberg, Damien F.; Peace, James; Gow, J.A.

doi:10.1016/j.ophtha.2013.07.006

Cited by 33 publications

(54 citation statements)

References 35 publications

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“…The therapeutic efficacy of bromfenac 0.07 % for the management of postoperative inflammation and pain following cataract surgery has been evaluated in two doubleblind, placebo-controlled, multicentre, phase III studies [14]. Data from the intent-to-treat populations of these studies are available as an integrated analysis [14].…”

Section: Therapeutic Efficacy Of Bromfenac 007 %mentioning

confidence: 99%

“…Data from the intent-to-treat populations of these studies are available as an integrated analysis [14].…”

Section: Therapeutic Efficacy Of Bromfenac 007 %mentioning

confidence: 99%

“…Patients aged C18 years and scheduled for unilateral cataract surgery (phacoemulsification or extracapsular cataract extraction) with posterior chamber intraocular lens implantation and no other concurrent ophthalmic surgical procedures were eligible for enrolment [14]. Patients were required to have a non-study eye visual acuity of 0.6 logarithm of the minimum angle of resolution or better (Snellen equivalent of 20/80 or better) and a study eye intraocular pressure of 5-22 mmHg.…”

Section: Therapeutic Efficacy Of Bromfenac 007 %mentioning

confidence: 99%

“…any cells or flare in the anterior chamber) in either eye at the screening visit, including ongoing, unresolved uveitis; and ocular pain [defined as an ocular comfort grading assessment (OCGA) pain scale score of [0] in either eye at the screening visit. The recent use of anticoagulants, corticosteroids, immunomodulators, NSAIDs and pain-relieving medication [except for acetaminophen (up to 4000 mg/day) or the use of an opioid during surgery], among others, was not permitted during the studies [14].…”

Section: Therapeutic Efficacy Of Bromfenac 007 %mentioning

confidence: 99%

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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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Section: Therapeutic Efficacy Of Bromfenac 007 %mentioning

confidence: 99%

“…Data from the intent-to-treat populations of these studies are available as an integrated analysis [14].…”

Section: Therapeutic Efficacy Of Bromfenac 007 %mentioning

confidence: 99%

Section: Therapeutic Efficacy Of Bromfenac 007 %mentioning

confidence: 99%

Section: Therapeutic Efficacy Of Bromfenac 007 %mentioning

confidence: 99%

See 2 more Smart Citations

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

Hoy

2015

Clin Drug Investig

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“…Fourteen more papers were further excluded because of lacking parallel placebo control. Finally, the remaining four publications, [22][23][24][25] reporting data from 10 RCTs, met our selection criteria and were included in the pooled-analysis (Supplementary Figure 1).…”

Section: Search Resultsmentioning

confidence: 99%

Topical bromfenac for post-cataract extraction: A systematic review and pooled analysis

Zhai

et al. 2015

Eur J Inflamm

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Bromfenac, a promising ophthalmic non-steroidal anti-inflammatory drug, has been used once daily for postoperative ocular inflammation and pain with satisfying efficacy, however, no integrated conclusion on its safety in clinical settings has been drawn. The purpose of this pooled analysis is to investigate the safety and efficacy of once daily bromfenac for ocular inflammation and pain among patients after cataract extraction (CE). MEDLINE, PsycINFO, Scopus, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched from inception to September 2014. Randomized controlled trials (RCTs) that studied topical bromfenac after CE were analyzed. Included studies were systemically reviewed, and effects were summarized using odds ratio (OR) with suitable effect model. Four RCTs involving 2294 participants were included. Topical bromfenac significantly increased the proportion of cleared ocular inflammation (OR, 2.37; 95% confidence interval [CI], 1.83-3.07; P <0.00001), ocular pain free (OR, 5.14; 95% CI, 4.07-6.49; P <0.00001), and decreased risk of overall adverse events (OR, 0.47; 95% CI, 0.38-0.58; P <0.00001). Bromfenac has been shown to be a safe and effective treatment for postoperative pain and inflammation in subjects undergoing CE. This is evidenced by the lower incidence of adverse events and the low scores for ocular pain and inflammation across multiple RCTs. However, demographics, co-morbidities of study participants, and the amount of co-medication were not reported, these possible sources of heterogeneity should be examined in future clinical trials.

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