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bromfenac (BromSite / bromfenac, InSite / ISV 303)

✓ Approved

Sun Pharmaceutical Industries Ltd. · PTGS2 · Small Molecule

What is bromfenac?

bromfenac is a small molecule developed by Sun Pharmaceutical Industries Ltd.. It is approved for therapeutic indications via others.

Drug Profile

Brand NamesBromSite, bromfenac, InSite, ISV 303
CompanySun Pharmaceutical Industries Ltd.
Drug ClassSmall Molecule
Molecular TargetPTGS2
RouteOthers
StatusApproved
Sources: ClinicalTrials.gov, Sun Pharmaceutical Industries Ltd.

Mechanism of Action

Molecular Targets

bromfenac acts on 1 molecular target:

PTGS2prostaglandin-endoperoxide synthase 2 (GRIPGHS, hCox-2)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

bromfenac is developed for 2 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Eye disordersCataract✓ Approved
Injury, poisoning and procedural complicationsProcedural pain✓ Approved

Related Research Articles

PubMedJournal of vitreoretinal diseases2026-09-30

Effect of Topical Bromfenac 0.09% on Pain Following Intravitreal Antivascular Endothelial Growth Factor Injections.

Achuck Kathryn K, Soares Rebecca R, Solish Danielle D, Popovic Marko M et al.

To evaluate the effect of topical bromfenac 0.09% on pain following intravitreal (IVT) injection of antivascular endothelial growth factor (anti-VEGF) medications in patients diagnosed as having choroidal neovascularization secondary to age-related macular degeneration or other etiologies, diabetic macular edema, diabetic retinopathy, or macular edema associated with retinal vein occlusion. A total of 78 adult patients scheduled to receive bilateral anti-VEGF IVT injections were randomized to receive topical bromfenac 0.09% in 1 eye and artificial tears in the fellow eye (control) immediately before the anti-VEGF treatment at 2 academic institutions from March 2021 to June 2022. Pain was evaluated using the Wong-Baker FACES Pain Rating Scale (score range, 0-10) and the Short-Form McGill Pain Questionnaire (score range, 0-5) at baseline (preinjection) and 5 minutes, 6 hours, and 24 hours following injection. Wilcoxon signed-rank sum test was used for statistical comparisons. In total, 156 eyes were analyzed. Mean baseline pain scores were similar between the bromfenac 0.09% and control groups. Five minutes after injection, eyes randomized to receive bromfenac 0.09% had significantly less pain compared with control eyes receiving artificial tears, on both the Wong-Baker FACES scale (mean raw score, 2.29 vs 2.79; P = .0275) and the McGill Pain Questionnaire (mean raw score, 1.13 vs 2.36; P = .0135). No significant difference in pain scores was noted at 6 hours or 24 hours post-IVT injection. Bromfenac 0.09% solution administered to the study eye before IVT anti-VEGF injection reduced pain 5 minutes after injection in comparison with artificial tears. There was no difference in pain between the 2 groups at 6 hours or 24 hours post-IVT injection.

PMID 42812627
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PubMedCureus2026-09-19

Incidence and Time to Onset of Pseudophakic Cystoid Macular Edema (Irvine-Gass Syndrome) After 1,325 Consecutive Cataract Surgeries Performed by a Single Surgeon Over Four Years.

Matsuo Toshihiko T, Nakago-Matsuo Chie C

Objectives Macular edema after cataract surgery is known as pseudophakic cystoid macular edema or Irvine-Gass syndrome. The aim of this study was to determine the incidence and time to onset of cystoid macular edema after uncomplicated cataract surgery. Methods  A retrospective review was conducted of 1,325 consecutive cataract surgeries performed by a single surgeon at a single institution over four years, from January 2022 to December 2025. Results Among 1,325 eyes, one or more macular cysts were detected by optical coherence tomography in 27 eyes (2.0%) of 22 patients who complained of blurred vision or decreased visual acuity after having no symptoms immediately after surgery. The 22 patients (27 eyes: 12 right and 15 left) comprised 12 men and 10 women. Their ages at the time of surgery ranged from 57 to 82 years, with a median of 75.5 years. Of the 27 eyes that developed macular cysts, 13 eyes with no preoperative or intraoperative risk factors for inflammation received topical 0.1% bromfenac twice daily as the only postoperative anti-inflammatory treatment, together with topical antibacterial 0.5% moxifloxacin four times daily. In contrast, the remaining 14 eyes, which had risk factors for inflammation, such as exfoliation, floppy iris, poor mydriasis, extracapsular cataract extraction, or diabetes mellitus, received topical bromfenac twice daily and 0.1% betamethasone (or 0.1% fluorometholone in two eyes) four times daily, as well as topical moxifloxacin. The time from surgery to the diagnosis of macular cysts ranged from one week to eight months, with a median of two weeks, in the 13 eyes treated with topical bromfenac only. In the 14 eyes treated with the combination of topical bromfenac and betamethasone, the time to diagnosis ranged from two weeks to 13 months, with a median of two months. In 26 of the 27 eyes, the macular cysts disappeared and visual acuity returned to normal without residual symptoms within two weeks to seven months, with a median of one month, after topical betamethasone four times daily was initiated or resumed. Conclusions  Pseudophakic macular cysts developed during the postoperative course in eyes with no preoperative or intraoperative risk factors that received topical bromfenac alone. They also developed later in the postoperative course after the combination of topical bromfenac and betamethasone was discontinued in eyes with risk factors for inflammation. The macular cysts disappeared following the initiation or resumption of topical betamethasone, accompanied by recovery of visual acuity and resolution of symptoms.

PMID 42762026
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PubMedSensors (Basel, Switzerland)2026-09-15

An Optimal Receiver Deployment Method for Achieving Robust Localization Performance in Practical Environments.

Park Bosung B, Keun Jongho J, Choo Hosung H

In this paper, we propose a receiver deployment optimization method that ensures robust localization performance under Direction of Arrival (DoA) estimation errors arising in practical environments. The proposed method accounts for DoA estimation errors and optimizes receiver deployments by incorporating Position Dilution of Precision (PDoP) to mitigate their amplification into localization errors. To accurately characterize DoA estimation errors under realistic propagation and installation constraints, a ray-tracing-based Wireless InSite simulator is employed to model environments including actual terrain and buildings. Based on this model, a cost function incorporating both the DoA estimation errors at each receiver and the PDoP is defined, and a Genetic Algorithm (GA) is applied to minimize this cost function and determine the optimal receiver deployment. The optimal deployment achieves low localization RMSE and maintains high robustness against environmental and system uncertainties, particularly when the standard deviation of the DoA estimation error exceeds approximately 8°. These results demonstrate that the proposed deployment method provides reliable localization performance in realistic propagation environments and remains robust against increasing DoA estimation errors.

PMID 42740106
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PubMedPloS one2026-08-27

Efficacy of a one-week course of topical bromfenac combined with corticosteroid for prevention of pseudophakic cystoid macular edema (PCME).

Kim Yoon Soo YS, Song Myung-Sun MS, Eom Young Sub YS, Song Jong Suk JS et al.

To compare the efficacy of a 1-week postoperative regimen of topical bromfenac combined with corticosteroid versus corticosteroid monotherapy in preventing pseudophakic cystoid macular edema (PCME). This retrospective study included 226 eyes of 226 patients who underwent uneventful phacoemulsification. Patients were divided into Group A (n = 158), receiving topical bromfenac 0.1% twice daily (BID) plus prednisolone acetate 1% (PDE) 6 times daily (6/d) or every 2 hours while awake (q2hrs), and Group B (n = 68), receiving PDE alone 6/d or q2hrs for the first postoperative week. Macular thickness was measured by Spectral-domain optical coherence tomography (SD-OCT) preoperatively and at postoperative week 5. PCME was defined as an increase in central subfield macular thickness (CSMT) with foveal cystoid changes. CSMT changes and PCME incidence were compared. A subgroup analysis evaluated the effect of PDE dosing frequency within the combination arm (6/d vs. q2hrs). Postoperative absolute and relative CSMT changes were significantly smaller in Group A (13.3 ± 13.0 μm, 5.6 ± 5.3%) than in Group B (27.0 ± 33.7 μm, 11.2 ± 14.3%; p = 0.002). The incidence of OCT-defined PCME was lower in Group A than in Group B (5.1% vs. 16.2%; OR = 0.28; 95% CI 0.11-0.72; p = 0.006). Among eyes developing PCME, the median CSMT increase was lower in Group A (38.5 μm) than in Group B (80.0 μm; p = 0.031). PCME incidence was numerically lower in [Bromfenac BID + PDE q2hrs] subgroup than [Bromfenac BID + PDE 6/d] subgroup (2.0% vs. 10.0%, OR = 0.19; 95% CI 0.04-0.79; p = 0.054). A one-week course of topical bromfenac combined with topical corticosteroid therapy was associated with smaller postoperative increases in macular thickness and a lower incidence of OCT-defined PCME than corticosteroid monotherapy after cataract surgery.

PMID 42658891
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PubMedRSC advances2026-08-08

Sustainable spectrophotometric fingerprinting resolution technique for concurrent quantification of ofloxacin and bromfenac in rabbit aqueous humor with ocular pharmacokinetic application.

Khafagy El-Sayed ES, Abu Lila Amr Selim AS, Al Saqr Ahmed A, Aldawsari Mohammed F MF et al.

The simultaneous quantification of multiple drugs in biological matrices is crucial for therapeutic drug monitoring and pharmacokinetic studies. A sustainable spectrophotometric fingerprinting resolution technique was developed for the simultaneous determination of ofloxacin (OFL) and bromfenac (BMF) in rabbit aqueous humor. The technique manipulates spectral data to extract the original zero-order absorption spectrum (D 0) of each analyte from overlapping signals in the mixture. This approach relies on the ratio subtraction method (RSM) combined with one or more additional methods, including extended ratio subtraction (ERS), unified constant subtraction (UCS), constant multiplication (CM), or spectrum subtraction (SS). Validation per ICH-Q2R1 showed a linearity range of 1-16 µg mL-1 for both drugs, with LOD/LOQ values between 0.16 and 0.63 µg mL-1. Following a simple protein-precipitation step, the technique was successfully applied to spiked rabbit aqueous humor samples, with recoveries between 97.8% and 102.1%. Matrix effect assessment confirmed negligible interference, with ME% values of -1.12% (OFL) and -0.98% (BMF). The validated technique was then used in an ocular pharmacokinetic study in rabbits following a single topical instillation of a combined OFL-BMF ophthalmic solution. The concentration-time profiles of both drugs in aqueous humor were effectively characterized, and key pharmacokinetic parameters were determined. Sustainability assessment indicated excellent trichromatic scores, confirming their suitability for ocular matrix analysis. This technique offers a sustainable platform for analyzing OFL and BMF in biological fluids, making it highly valuable for ocular bioavailability and pharmacokinetic studies.

PMID 42569095
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PubMedJournal of drug delivery science and technology2026-07-30

Simultaneous sustained delivery of NSAID bromfenac and lubricant polyvinylpyrrolidone by vitamin E nanobarrier contact lenses.

Kumara Bommanahalli Nagaraju BN, Chauhan Anuj A

Cataract surgery is commonly followed by daily administration of multiple eye-drops of antibiotics and anti-inflammatory drugs such as moxifloxacin, dexamethasone and bromfenac. Drop-less cataract surgery eliminates the need for the eye drops by injecting medications into the eye during surgery or by inserting devices such as puncta plug to achieve sustained delivery of the drugs. We propose to develop an alternative approach for drop-less cataract surgery by delivering the anti-inflammatory bromfenac via contact lenses (CLs). The sustained delivery is achieved by increasing tortuosity in the lens by loading vitamin E at 0, 10, 20 or 30% (w/w) into the ACUVUE® OASYS CLs. Additionally, polyvinylpyrrolidone (PVP) was loaded into the CLs to improve lubricity. The drug and PVP are loaded by soaking in aqueous solutions containing 0.5-5 mg/mL bromfenac and/or 5-15 mg/mL PVP. Incorporation of vitamin E increased the release duration of bromfenac to 7 and 15 days for 20% and 30% vitamin E loadings. The vitamin E incorporation did not impact the release duration of PVP likely because PVP is unable to diffuse into the lens due to the high molecular weight. Bromfenac incorporation led to an increase in release duration of PVP suggesting interaction between the drug bromfenac and the lubricant PVP. The SEM imaging also shows that the combination of bromfenac and PVP results in formation of surface adsorbed aggregates which dissolve during the release phase. The vitamin E, bromfenac and PVP loaded lenses retained key properties of transparency. The bromfenac, PVP, and vitamin E loaded CLs could be an attractive option for postoperative care after cataract surgery to improve therapy and reduce patient burden.

PMID 42529610
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