Bromfenac Group Research Articles

One-year Clinical Outcome of Topical Bromfenac in Central Serous Chorioretinopathy

Purpose: To evaluate the efficacy of topical bromfenac in treating central serous chorioretinopathy (CSC) over a 1-year period.Methods: A retrospective analysis was conducted on 57 patients (57 eyes) with CSC followed for > 1 year. Patients were divided into two groups: those treated with bromfenac eye drops twice daily (29 eyes) and a control group (28 eyes). Best-corrected visual acuity (BCVA), central macular thickness (CMT), and subretinal fluid (SRF) height were measured and compared between the two groups as was the proportion of chronic cases.Results: Significant improvements in CMT and SRF height were noted in both groups over the follow-up period. The bromfenac group demonstrated significantly lower CMT at 6, 9, and 12 months (p = 0.045, 0.042, and 0.023, respectively) and lower SRF height (p = 0.037, 0.048, and 0.046, respectively) compared to the control group. The proportion of chronic cases was significantly lower in the bromfenac group (17.2%) compared to the control group (42.9%, p = 0.035).Conclusions: Topical bromfenac reduced the rate of progression to chronic CSC and showed significant anatomical improvements after 6 months, suggesting its potential as an effective treatment option.

Clinical Outcomes of Topical Bromfenac Combined with Intravitreal Aflibercept Injection for Exudative Age-related Macular Degeneration

Purpose: To evaluate the efficacy of topical bromfenac combined with intravitreal aflibercept (IVA) injection in the treatment of exudative age-related macular degeneration over a 2-year period.Methods: We retrospectively studied 43 patients (43 eyes) with exudative age-related macular degeneration. Patients were included if they received IVA injections under an as-needed protocol and had > 2 years of follow-up. Among the 43 eyes, 25 received only IVA (IVA group), whereas 18 received a combination of IVA and topical bromfenac (bromfenac group). The primary outcome measure was the total number of IVA injections administered over 2 years from the initial injection compared between groups. We also compared changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) between groups.Results: The bromfenac group received a significantly lower number of IVA injections over 2 years (7.4 ± 1.0), compared with the IVA group (9.0 ± 1.9) (<i>p</i> < 0.01). Both groups showed improvements in BCVA and CRT after 2 years compared with their baseline values. However, changes in BCVA and CRT at 2 years did not significantly differ between groups (<i>p</i> = 0.786 and <i>p</i> = 0.905, respectively).Conclusions: Among patients with exudative age-related macular degeneration, the total number of IVA injections over 2 years was lower in the bromfenac group than in the IVA group. More studies are needed to confirm the efficacy of topical bromfenac in a combined treatment regimen.

Comparison of the Effect of Bromfenac versus Betamethasone Ophthalmic Solutions in Patients with Diabetic Macular Edema

Purpose To examine the effect of 0.1% bromfenac (BF) ophthalmic solution and 0.1% betamethasone (BM) ophthalmic solution on diabetic macular edema (DME). Methods This was a prospective trial. Nineteen patients (mean age of 66.6 ± 10.1 years) with DME and mean retinal thickness within a diameter of 1 mm from the fovea (central subfield thickness: CST) of 250–500 µm were randomized and instilled with BF or BM. CST, best-corrected visual acuity (BCVA), and intraocular pressure (IOP) were measured at 4, 8, and 12 weeks after administration. Results CST at baseline (p = .128) and that at 4, 8, and 12 weeks of administration was not significantly different between the BF (10 patients) and BM groups (9 patients). In patients with glycated hemoglobin (HbA1c) <8.0%, CST, compared with baseline, was significantly decreased in the BF group (seven patients) at 8 (p = .025) and 12 weeks (p = .043) of administration. When compared with the baseline, no significant changes in BCVA were observed at any point in time in either group. Baseline IOP was comparable between the groups. In the BM group, the values of change in IOP from baseline significantly increased at 8 (p = .025) and 12 weeks (p = .044) of administration, with no significant changes in IOP over the 12 weeks of administration in the BF group. Conclusions BF did not affect IOP even after 12 weeks of administration, suggesting its effect in reducing CST in DME with good glycemic control. Trial registration University Hospital Medical Information Network (UMIN-CTR); UMIN000026201, February 18, 2017; Japan Registry of Clinical Trials; jRCTs031180308, March 15, 2019

Topical 0.1% Nepafenac versus 0.09% Bromfenac Eye Drops for Inflammation after Laser Peripheral Iridotomy: A Randomized Controlled Trial

To assess the safety and efficacy of 0.1% nepafenac versus 0.09% bromfenac eye drops in controlling inflammation after neodymium yttrium-aluminum-garnet (YAG) laser peripheral iridotomy (LPI). Single-masked, single-center, randomized controlled trial. One hundred and sixty eyes of patients with primary angle-closure suspect (PACS) and primary angle closure (PAC) undergoing bilateral LPI. Patients were randomized in a 1:1 ratio to receive 0.1% nepafenac thrice daily or 0.09% bromfenac eye drops twice daily for 2 weeks after neodymium YAG LPI. Assessment was performed by masked investigators at 2 weeks after LPI. A Glaucoma Symptom Scale (GSS) questionnaire was administered both at baseline and 2 weeks after LPI. Subjective comfort scores to the study medications were assessed on the basis of a Likert scale at 2 weeks after LPI. In patients with bilateral PACS or PAC, the right eye was analyzed, and in asymmetrical disease (i.e., when one eye had PACS and the other eye had PAC), the eye with PAC was analyzed. The primary outcome (end point) was uncontrolled inflammation, defined as symptomatic inflammation within 1 week after LPI, the presence of anterior chamber cells at 2 weeks, or rebound inflammation after medication discontinuation. The secondary outcome was patient-reported comfort levels with study medications based on the GSS and Likert scale. At 2 weeks after LPI, 7 patients (6 with PACS and 1 with PAC) in the nepafenac group and 2 patients with PACS in the bromfenac group achieved the primary end point, without a difference between the medication groups (P= 0.09). Post-LPI burning, smarting, and stinging was more common in the bromfenac group (P= 0.01), which also had a higher comfort score on the Likert scale (P= 0.004). The need for repeat LPI was comparable (10.0% in the nepafenac group vs. 15.4% in the bromfenac group; P= 0.22). A multivariate analysis revealed that a greater number of laser shots was associated with the need for repeat LPI (odds ratio, 1.05; 95% confidence interval, 1.00-1.10; P= 0.04). Topical 0.09% bromfenac is noninferior to 0.1% nepafenac in controlling inflammation after LPI in eyes with PACS and PAC. Nepafenac may be associated with higher patient-reported comfort.

COMPARISON OF THE EFFECT OF TOPICAL BROMFENAC AND TOPICAL FLURBIPROFEN IN MAINTAINING MYDRIASIS DURING CATARACT SURGERY

At the time of cataract surgery, one of the challenges a surgeon encounters is intraoperative miosis. This might increase the chances of intraoperative and postoperative complications. Thus, maintainence of adequate pupillary dilatation is necessary during cataract surgery. Aim of the study was to compare the effectiveness of prophylactic administration of topical bromfenac (0.09 % w/V) and topical flurbiprofen (0.03 % w/V) in maintaining mydriasis during the cataract surgery. A total of 100 patients were randomly divided into two groups of 50 each. Group 1 received topical bromfenac (0.09 %) and Group 2 received topical flurbiprofen (0.03 %). The mean percentage loss of mydriasis from the baseline was lesser in bromfenac group compared to flurbiprofen group (p &lt; 0.001). Topical bromfenac was found to be more effective in maintaining mydriasis during the cataract surgery when compared to the topical flurbiprofen.

Topical bromfenac reduces multiple inflammatory cytokines in the aqueous humour of pseudophakic patients

Intraocular surgery is associated with increased ocular inflammation. If maintained for a prolonged period after surgery, this inflammation can cause various complications, including subconjunctival fibrosis and bleb scarring. This clinical trial was a prospective, randomised, single-blind, interventional study comparing the efficacy and safety of 0.1% bromfenac sodium ophthalmic solution and 0.02% fluorometholone ophthalmic suspension in the inhibition of multiple inflammatory cytokines in the aqueous humour of 26 patients with pseudophakic eyes who had undergone phacoemulsification and intraocular lens implantation. The patients were randomly assigned to one of the trial drugs, and aqueous humour samples were collected before and after drug administration. Platelet-derived growth factor-AA levels significantly decreased in both drug groups, but they were significantly higher in the fluorometholone group than in the bromfenac group (P = 0.034). Bromfenac also significantly decreased vascular endothelial growth factor level (P = 0.0077), as well as monocyte chemoattractant protein-1 level (P = 0.013), which was elevated for a prolonged period after phacoemulsification. These data suggest that bromfenac is useful to alleviate prolonged microenvironmental alterations in the aqueous humour of pseudophakic eyes.

Economic evaluation of prevention of cystoid macular edema after cataract surgery in patients without diabetes: ESCRS PREMED study report 4.

To investigate the cost-effectiveness of prophylactic treatments against cystoid macular edema (CME) after cataract surgery in patients without diabetes. Seven ophthalmology clinics in the Netherlands and Belgium. Prospective cost-effectiveness analysis using data from a European multicenter randomized clinical trial (ESCRS PREMED). Patients without diabetes planned for expected uneventful cataract surgery were randomized to topical bromfenac (Yellox, n = 242), topical dexamethasone (n = 242), or a combination treatment (n = 238). All relevant resources from a healthcare perspective were included in the cost analysis within a time horizon of 12 weeks postoperatively. The main effectiveness outcome was quality-adjusted life years (QALYs). The main cost-effectiveness outcome was the incremental cost-effectiveness ratio (ICER) based on the cost per QALY. The study comprised 722 patients without diabetes. Total healthcare costs and QALYs were € 447 (US $562) and 0.174 in the bromfenac group, €421 (US $529) and 0.179 in the dexamethasone group, and €442 (US $565) and 0.182 in the combination group. Bromfenac was most costly and least effective (ie, strongly dominated). The ICER was €6544 (US $8221) per QALY for the combination group compared with the dexamethasone group. Assuming that the willingness to pay is € 20 000 (US $25 126) per QALY, the cost-effectiveness probability was 3%, 32%, and 65% in the bromfenac, dexamethasone, and combination groups, respectively. In patients without diabetes, combination treatment with topical bromfenac and dexamethasone was effective and cost-effective in preventing CME after cataract surgery compared with treatment with either drug alone.

Effect of 0.1% Bromfenac for Preventing Macular Edema after Cataract Surgery in Patients with Diabetes.

PurposeTo investigate the effect of 0.1% bromfenac sodium hydrate ophthalmic solution for prevention of macular edema after cataract surgery in patients with diabetes.MethodsA retrospective analysis of 75 patients with diabetes who underwent cataract surgery was performed. Thirty-eight patients (52 eyes) were instilled with 0.1% bromfenac solution (bromfenac group) and 37 patients (46 eyes) were not (control group).ResultsThere were no significant preoperative between-group differences. Compared to the control group, at 1 month after surgery, the bromfenac group showed slightly better best-corrected visual acuity (0.12 ± 0.12 vs. 0.32 ± 0.42, p = 0.142), lower central macular thickness (265.58 ± 31.28 vs. 314.15 ± 76.11 µm, p < 0.001), and lower macular volume (8.46 ± 0.60 vs. 9.14 ± 1.53 mm3, p = 0.022). There were no significant differences between the two groups at 4 and 6 months postoperatively (p > 0.05). Mean changes in central macular thickness showed significant differences at 1 and 4 months postoperatively (−1.44 ± 11.72 and 10.44 ± 22.48 µm in bromfenac group vs. 47.19 ± 70.24 and 31.69 ± 48.04 µm in control group, p < 0.001 and p = 0.016) and mean changes in macular volume showed a significant difference at 1 month postoperatively (−0.08 ± 0.47 mm3 in bromfenac group vs. 0.58 ± 1.28 mm3 in control group, p < 0.001). There were no significant differences thereafter (p > 0.05).ConclusionsTreatment with 0.1% bromfenac sodium hydrate ophthalmic solution showed good efficacy for preventing cystoid macular edema early after cataract surgery in patients with diabetes.

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.

IntroductionThis 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.MethodsAdults 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.ResultsThe 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.ConclusionsThe 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.FundingBausch & Lomb Incorporated.Trial RegistrationNCT03886779.

Topical bromfenac sodium in femtosecond laser-assisted cataract surgery

PurposeTo evaluate the effect of preoperative 0.09% bromfenac ophthalmic solution for the reduction of intraoperative miosis and pain in patients who have undergone femtosecond laser-assisted cataract surgery. MethodsThis prospective randomized clinical study included 65 patients with senile cataracts in the absence of significant ocular comorbidity. The patients received 0.09% bromfenac ophthalmic solution or control placebo twice a day for 3 days before surgery. Pupil diameter was measured at the initiation and finalization of femtosecond laser-assisted cataract surgery, and pain quantification was assessed by an analogous pain scale after one day of follow-up. ResultsA total of 65 patients were randomly divided into two groups. Five patients were excluded due to defective coupling with the laser interface. Each of the 60 patients was randomized to receive preoperative topical treatment with either 0.09% bromfenac or 0.1% sodium hyaluronate. Baseline characteristics were similar between groups for age and gender. The mean change in horizontal and vertical pupil diameter from the preoperative to post-femtosecond laser measurements were significantly less in the bromfenac group than in the placebo group (0.43 ± 0.6 vs. 1.71 ± 0.9, P < 0.001 and 0.40 ± 0.6 vs. 1.78 ± 0.9, P < 0.001, respectively). Compared with untreated patients, the quantification of pain one day after the procedure was significantly lower in the 0.09% bromfenac group (46.7% with a score of 3 vs. 50% with a score of 1, P < 0.001, respectively). ConclusionsThe maintenance of pupil dilation and the prevention of miosis were more effective in the 0.09% bromfenac group than in the control group. Likewise, the greater control of postoperative pain represented an additional significant benefit.

Comparison of Once-Daily Bromfenac 0.07% Versus Once-Daily Nepafenac 0.3% in Patients Undergoing Phacoemulsification.

AimRandomized pilot study comparing clinical outcomes with bromfenac ophthalmic solution 0.07% versus nepafenac 0.3% ophthalmic suspension administered as identical dosing regimens in patients undergoing uncomplicated phacoemulsification with intraocular lens implantation.MethodsForty-nine subjects were treated with bromfenac (n = 25) or nepafenac (n = 24) once daily starting 3 days before cataract surgery, continued on the day of surgery, and for 21 days following surgery, in addition to standard of care. Subjects were followed at 1 day and 7, 21, and 42 days postoperatively. Assessments included best-corrected visual acuity [Early Treatment Diabetic Retinopathy Study (ETDRS)], summed ocular inflammation score (SOIS; anterior chamber cells plus flare grading), macular volume and thickness (spectral domain optical coherence tomography), intraocular pressure, and adverse events.ResultsTreatment groups were similar at baseline. Outcomes for mean letters read (p = 0.20), mean change in macular volume (p = 0.98), and retinal thickness (p = 0.93) were not statistically different between the groups at day 42. Mean SOIS dropped markedly and similarly from post-surgical day 1 to day 7 in both treatment groups and was statistically equivalent to baseline in both groups by day 21. At day 42, 87% of subjects in the bromfenac group and 82% of subjects in the nepafenac group demonstrated stable or improved visual acuity. The proportions of eyes with mean retinal thickness of 10 µm or less at days 7, 21, and 42 were similar for the bromfenac (95.8%, 78.3%, 73.9%, respectively) and nepafenac (91.7%, 87.5%, 66.7%) groups (all p = NS, bromfenac vs. nepafenac).ConclusionBoth bromfenac 0.07% and nepafenac 0.3% produced positive and similar clinical outcomes with regard to ETDRS visual acuity post-cataract surgery when dosed using identical regimens. Increases in mean retinal thickness and mean macular volume were small and similar between treatments.Trial Registration numberNCT01847638.FundingBausch & Lomb Incorporated.

Comparative Study Of The Effect Of Topical Corticosteroid With Non-Steroidal Anti Inflammatory Agents On Post-Operative Inflammation And Corneal Astigmatism After Cataract Surgery.

Purpose:To compare the effects of topical corticosteroid with non-steroidal anti-inflammatory agents on postoperative control of inflammation, pain and corneal astigmatism.&#x0D; Setting: Indira Gandhi Government General Hospital &amp; Postgraduate Institute, Puducherry.&#x0D; Methods:A prospective comparative study in two hundred patients with visually significant cataract, undergoing manual small incision cataract surgery with implantation of posterior chamber intraocular lens were randomly assigned into four groups with minimum 50 patients in each. All cases of uncomplicated cataract surgery were assigned to following groups to receive one of the following topical anti-inflammatory agents as postoperative medications: Group A- 1% predinsolone acetate, Group B -0.5% ketorolac tromethamine, Group C 0.09% Bromfenac eye drops, Group D 0.1% Nepafenac eye drops. All patients were examined on 1 day (baseline), 3th day, 5th day, 7th day, 14th day and 1month after surgery for assessment of ocular pain, anterior chamber cells and flare and corneal astigmatism.&#x0D; Results:The cells and flare were least in bromfenac group on the 3rd postoperative day.Nepafenac is effective in inflammation control from 5th postoperative day. There was a significant association of use of drug and severity of ocular pain upto 1stpostoperative week. There was statistically significant difference between NSAIDs and steroid on postoperative astigmatism (P &lt;0.001).&#x0D; Conclusions:Bromfenac is effective as an anti-inflammatory agent in the immediate postoperative period. All the NSAIDs are found to be as effective as steroid after 1 week onwards. The NSAIDs showed reduced astigmatism changes and stabilizes astigmatism much quicker than steroids.

A prospective evaluation of efficacy and safety of topical bromfenac 0.09% over topical flurbiprofen 0.03% after cataract surgery

Background: Different medications are used to reduce pain and inflammation after cataract surgery. Hence this study was taken up to compare the efficacy and safety of topical bromfenac 0.09% over topical flurbiprofen 0.03% in reducing anterior chamber inflammation and pain after cataract surgery.Methods: Total of 100 patients who underwent uneventful cataract surgery with posterior chamber intra ocular lens (IOL) implantation were randomly allocated to receive bromfenac 0.09% and flurbiprofen 0.03% topically from first post-operative day onwards for 6 weeks. Assessment of anterior chamber inflammation and pain was done by slit lamp and visual analogue scale respectively on each follow up days. Analysis was done by unpaired t test and Fischer’s exact test.Results: The response to treatment was earlier in bromfenac group for all the inflammatory changes (significant difference was found on day 7, p&lt;0.05) except for corneal edema where both the groups showed similar response. On 7th day after surgery, 72% patients in flurbiprofen group and 12% in bromfenac group had pain (score1), while on the 14th day none in the bromfenac group complained of pain whereas 4% in flurbiprofen group still had pain. Both the drugs were safe and no clinically serious adverse effects were observed in either of the groups.Conclusions: This study showed both the medications, topical bromfenac 0.09% and topical flurbiprofen 0.03% effective and safe in reducing pain and anterior chamber inflammation after cataract surgery but the response was earlier with bromfenac 0.09%.

Comparison of clinical effects between bromfenac sodium versus loteprednol etabonate following FS-LASIK

Objective To compare the efficacy, safety and tolerability between bromfenac sodium ophthalmic solution 0.1% eye drop and loteprednol etabonate 0.5% eye drop after femtosecond laser in situ keratomileusis (FS-LASIK). Methods A prospective randomized controlled trail was performed.Seventy-six patients who had been undergone FS-LASIK in Daping Hospital were enrolled from December 2013 to December 2014.They were divided into two groups randomly by using the random number table method.The bromfenac sodium group included 38 patients administered 0.1% bromfenac sodium ophthalmic solution, and the loteprednol etabonate group comprised 38 patients treated with 0.5% loteprednol etabonate.Patients in both groups initially administered tobramycin-dexamethasone four times a day after FS-LASIK for 1 week.Then the patients in the bromfenac sodium group were treated with bromfenac sodium twice a day until 1 month postoperatively.While the patients from the loteprednol etabonate group were treated with loteprednol etabonate twice a day until 1 month after surgery.Visual acuity, refraction, intraocular pressure and ocular manifestation were examined preoperative and 1 day, 1 week, 1 month, 3 months, 6 months after FS-LASIK.This study was approved by the medical ethics Committee of Daping Hospital. Results No significant difference was found in the rate of uncorrected visual acuity (UCVA) which achieved to preoperative best corrected visual acuity (BCVA) between the two groups at each time point after operation (χ2=8.000, P=0.613). There was no difference in spherical equivalent (SE) between the two groups postoperatively (Fgroup=1.137, P=0.288), but a significant difference was found between the different time points (Ftime=29.771, P=0.000). Postoperative SE in the two groups tended to have mild hyperopia in the early days, and then gradually tended to zero or mild myopia.There was a significant difference with intraocular pressure among different time points (Ftime=87.519, P=0.000), but no significant difference of intraocular pressure was found between the groups (Fgroup=1.989, P=0.161). One month after surgery, the intraocular pressure were higher than 20 mmHg in two eyes in the loteprednol etabonate group, and two eyes were 5 mmHg higher than preoperative intraocular pressure.In bromfenac group, no one was higher than 5 mmHg compared with the preoperative intraocular pressure, and the pressures of all the eyes were lower than 18 mmHg.All the patients in bromfenac group were no drug withdrawal.But three patients were forced to guide drug withdrawal due to high intraocular pressure in loteprednol group. Conclusions Bromfenac sodium is safe, effective and well tolerated after FS-LASIK. Key words: Femtosecond laser in situ keratomileusis; Bromfenac sodium; Loteprednol etabonate; Intraocular pressure; Corneal refractive surgery

European multicenter trial of the prevention of cystoid macular edema after cataract surgery in nondiabetics: ESCRS PREMED study report 1

To compare the efficacy of a topical nonsteroidal antiinflammatory drug, topical corticosteroid, and a combination of both drugs to prevent the occurrence of cystoid macular edema (CME) after cataract surgery in nondiabetic patients. Twelve European study centers. Randomized clinical trial. Nondiabetic patients having uneventful cataract surgery were included in this study. Patients were randomized to receive topical bromfenac 0.09% twice daily for 2weeks or dexamethasone 0.1% 4 times daily with 1 drop less per day every following week, or a combination of both. The primary outcome was the difference in central subfield mean macular thickness 6weeks postoperatively. Secondary outcome measures included corrected distance visual acuity as well as the incidence of CME and clinically significant macular edema (CSME) within 6weeks and 12weeks postoperatively. This study comprised 914 patients. Six weeks postoperatively, the central subfield mean macular thickness was 288.3μm, 296.0μm, and 284.5μm in the bromfenac group, dexamethasone group, and combination treatment group, respectively (overall P=.006). The incidence of clinically significant macular edema within 12weeks postoperatively was 3.6%, 5.1%, and 1.5%, respectively (overall P=.043). Patients treated with a combination of topical bromfenac 0.09% and dexamethasone 0.1% had a lower risk for developing CSME after cataract surgery than patients treated with a single drug.

Comparison of the Efficacy of Dexamethasone, Nepafenac, and Bromfenac for Preventing Pseudophakic Cystoid Macular Edema: an Open-label, Prospective, Randomized Controlled Trial

ABSTRACTPurpose: To evaluate the incidence of pseudophakic cystoid macular edema (PCMO) in patients treated with corticosteroids alone or in combination with bromfenac or nepafenac eyedrops after uneventful cataract surgery.Materials and Methods: Prospective, randomized, open-label, placebo-controlled clinical trial. Patients who underwent routine cataract surgery with intraocular lens (IOL) implant were randomly divided into three groups receiving either bromfenac or nepafenac in association with dexamethasone or dexamethasone alone (control group) postoperatively. Best-corrected visual acuity (BCVA) measurement, slit lamp and fundus examination and optical coherence tomography (OCT) were performed preoperatively, 1 and 5 weeks after surgery. Primary outcome was defined as patients (%) in whom macular edema developed within 5 weeks after cataract surgery; secondary end points were patients (%) with BCVA improvement from pre-op through 5 weeks after surgery and corneal toxicity.Results: A total of 144 patients completed the study, 48 for each group. In all groups, mean central subfield thickness at OCT increased significantly 5 weeks after surgery (p < 0.01). However, at this time point, four patients (8.3%) of the control group and none in nepafenac and bromfenac groups developed PCMO (p = 0.016). Compared with baseline, mean BCVA significantly improved both at 1 and 5 weeks in all groups (p < 0.01). At 1 week, the nepafenac group showed a mean BCVA significantly lower compared with both the control (p = 0.038) and bromfenac group (p = 0.002).Conclusions: Co-administration of nepafenac or bromfenac and steroids in patients who underwent routine cataract surgery is associated with a lower incidence of PCMO compared with steroid monotherapy.

Effect of postoperative administration of nonsteroidal antiinflammatory drugs and steroids on the conformational changes in wound healing after cataract surgery

To assess the changes in clear corneal incision (CCI) healing resulting from the postoperative administration of nonsteroidal antiinflammatory drugs (NSAIDs) or steroids using anterior segment optical coherence tomography (AS-OCT). Institute of Vision Research, Department of Ophthalmology, Yonsei University, Seoul, South Korea. Prospective randomized comparative study. Eyes having cataract surgery were randomly given an NSAID (bromfenac 0.1% [Bronuck]) or a steroid (prednisolone acetate 1.0% [Pred Forte]). Using AS-OCT, structural changes of CCIs were examined 1day and 1, 3.5, and 23weeks postoperatively. The incidence and size of 5 wound deformities (endothelial gape, Descemet membrane detachment, epithelial detachment or defect, posterior misalignment, loss of coaptation) were analyzed. The correlation between the mean total wound deformity scores (wound instability) and surgically induced astigmatism (SIA) was evaluated. The bromfenac group comprised 29 eyes and the prednisolone group, 30 eyes. During the 6-month follow-up, the overall changes in wound instability were not significantly different between groups, although epithelial detachment or a larger defect was more frequent in the bromfenac group between 1week and 3.5weeks postoperatively. The SIA at 1week was positively correlated with wound instability and wound instability at 1day was positively correlated with cataract grading in both groups. No significant difference in the conformational changes of cataract wounds (aside from increased epithelial detachment or defect in bromfenac group) was observed between NSAIDs and steroids administered postoperatively. In the early postoperative period, high wound instability was associated with SIA, possibly contributing to worse visual outcomes. None of the authors has a financial or proprietary interest in any material or method mentioned.

Bromfenac ophthalmic solution 0.09 %: human aqueous humor concentration detected by high-performance liquid chromatography

The purpose of this study was to evaluate the aqueous humor concentrations of bromfenac ophthalmic solution 0.09% in patients undergoing phacoemulsification. Patients requiring cataract extraction received one drop (50µL) of bromfenac 0.09% solution in the eye to be operated, before bedtime the day before surgery or the morning of the surgery. The last administration was recorded. At the time of paracentesis, an aqueous humor sample was collected with a 30-gauge needle attached to a TB syringe and was later analyzed by high-performance liquid chromatography for drug concentration. 188 treated volunteers and 48 control, untreated, subjects were included in the study. The mean aqueous concentration of bromfenac in the treated group was 37.60±68.86 and 0nM (nmol/L) in the control group (p<0.0001). Correlation coefficient in bromfenac group between time elapsed from instillation and drug concentration was -0.16 (p not significant). Bromfenac showed properties of good penetration and stable concentration in aqueous humor up to about 12h after instillation.

Bromfenac 0.09% bioavailability in aqueous humor, prophylactic effect on cystoid macular edema, and clinical signs of ocular inflammation after phacoemulsification in a Mexican population.

PurposeThe purpose of this study was to evaluate the aqueous humor bioavailability and clinical efficacy of bromfenac 0.09% vs nepafenac on the presence of cystoid macular edema (CME) after phacoemulsification.Material and methodsA Phase II, double-blind, masked, active-controlled, multicenter, clinical trial of 139 subjects, randomized to either a bromfenac 0.09% ophthalmic solution (n=69) or nepafenac 0.1% (n=70). Subjects instilled a drop three times a day for a period of 30 days. Follow-up visits were on days 2, 7, 15, 30, and 60. Biomicroscopy, clinical ocular signs, and assessment of posterior segment were performed. The primary efficacy endpoints included the presence of CME evaluated by optical coherence tomography. Safety evaluation included intraocular pressure, transaminase enzymes, lissamine green, and fluorescein stain.ResultsThe demographic and efficacy variables were similar between groups at baseline. The presence of pain, photophobia, conjunctival hyperemia, chemosis, cellularity, and corneal edema disappeared by day 30 in both groups. The central retinal thickness did not show significant changes after treatment when compared to baseline as follows: in the bromfenac group (247.2±32.9 vs 252.0±24.9 μm; P=0.958) and in nepafenac group (250.8±34 vs 264.0±34.1 μm; P=0.137), respectively. A statistically significant difference was observed between bromfenac and nepafenac group: (252.0±24.9 vs 264.0±34.1 μm; P=0.022), at day 30, respectively; even though there was no clinical relevance in the presentation of CME. There were no significant alterations in intraocular pressure, either lissamine green or fluorescein stains. The adverse events were not related to the interventions.ConclusionBromfenac 0.09% ophthalmic solution showed similar clinical efficacy to reduce the presentation of CME after phacoemulsification compared to nepafenac 0.01%.

Bromfenac Ophthalmic Solution 0.07% Dosed Once Daily for Cataract Surgery: Results of 2 Randomized Controlled Trials

To evaluate the efficacy and ocular safety of bromfenac ophthalmic solution 0.07% (Prolensa) dosed once daily for the treatment of ocular inflammation and pain in subjects who underwent cataract surgery with posterior chamber intraocular lens implantation. Two phase 3, randomized, double-masked, placebo-controlled, multicenter clinical trials. Four hundred forty subjects (440 study eyes: 222 in the bromfenac group and 218 in the placebo group). Two phase 3, prospective, randomized, double-masked, placebo-controlled clinical trials were conducted at 39 ophthalmology clinics in the United States. Subjects 18 years of age or older were randomized to receive either bromfenac 0.07% or placebo dosed once daily beginning 1 day before cataract surgery, on the day of surgery, and continuing for 14 days after surgery (for a total of 16 days). Subjects were evaluated on days 1, 3, 8, 15, and 22 after surgery. The primary efficacy end point was cleared ocular inflammation, as measured by the summed ocular inflammation score of zero (anterior chamber cell count= 0 and absence of flare) by day 15. Secondary end points included cleared ocular inflammation at day 15 and the number of subjects who were pain free at day 1. The data from the 2 clinical trials were integrated for analyses. Summed ocular inflammation score and ocular pain. A significantly higher proportion of subjects treated with bromfenac 0.07% achieved complete clearance of ocular inflammation by day 15 and at day 15 compared with placebo (P < 0.0001). A statistically significantly higher proportion of subjects in the bromfenac 0.07% group were pain free at all study visits compared with those in the placebo group (P < 0.0001). Fewer subjects in the bromfenac group (3.2%) discontinued investigational product early because of a lack of efficacy than in the placebo group (23.9%; P < 0.0001). The incidence of adverse events was significantly lower in the bromfenac 0.07% group compared with the placebo group (P=0.0041). Bromfenac ophthalmic solution 0.07% dosed once daily was clinically safe and effective compared with placebo for the treatment of ocular inflammation and pain in subjects who had undergone cataract surgery and may be a beneficial addition to the current standard of care, which commonly includes ophthalmic antibiotics and corticosteroids.