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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

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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PubMedKorean journal of ophthalmology : KJO2026-07-29

Central Macular Thickness, Subfoveal Choroidal Thickness, and Choroidal Vascularity Index After Phacoemulsification: Bromfenac versus Ketorolac.

Nah Jun Sung JS, Kim Kyoung Lae KL, Na Kyeong Ik KI, Choi Youn Joo YJ et al.

To evaluate the exploratory effects of topical bromfenac 0.1% and ketorolac 0.45% on the posterior segment following cataract surgery, focusing on the choroidal vascularity index (CVI) as a sensitive biomarker, and to explore the potential impact of different dosing regimens. This retrospective cohort study included 105 eyes (47 in the ketorolac group and 58 in the bromfenac group) that underwent uncomplicated phacoemulsification. Subgroups were stratified by dosing duration: Pre-only (no postoperative NSAID) and Pre+Post (one-month postoperative maintenance). Central macular thickness (CMT), subfoveal choroidal thickness (SCT), and CVI (total area [CVI Total] and central 1,500 µm subfield [CVI 1500]) were analyzed using enhanced depth imaging optical coherence tomography at baseline and one month postoperatively. Both drug groups showed comparable visual improvements and intraocular pressure reductions. Postoperatively, CMT and CVI significantly increased from baseline in both groups, while SCT increased significantly only in the bromfenac group (p = 0.003). Direct inter-group comparisons revealed no significant differences in the magnitude of anatomical changes (Δ). However, exploratory subgroup analysis showed that bromfenac maintenance therapy (Pre+Post) was associated with smaller increases in ΔCVI Total (0.3 ± 3.1% vs. 2.1 ± 3.6%; p = 0.027) and ΔCVI 1500 (0.3 ± 3.8% vs. 2.2 ± 4.0%; p = 0.044) compared to the Pre-only regimen, a trend not observed in CMT or SCT. Multivariable regression identified higher preoperative baseline values as independent predictors for smaller anatomical increases. Crucially, dosing duration independently predicted ΔCVI Total (p = 0.046), with maintenance therapy being associated with attenuated CVI increases. Prophylactic bromfenac and ketorolac demonstrated comparable overall efficacy in managing postoperative inflammation following cataract surgery. In this exploratory study, bromfenac maintenance therapy was associated with smaller postoperative CVI changes, suggesting a potential role for continued NSAID use in modulating early choroidal microvascular responses.

PMID 42521209
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PubMedGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2026-07-15

Bromfenac versus nepafenac for pain management following transepithelial photorefractive keratectomy.

Achiron Asaf A, Kagasov Shmuel S, Barequet Irit I, Klinghoffer Ben B et al.

To compare the efficacy of two topical NSAID eye drops, Bromfenac and Nepafenac, in reducing postoperative pain following transepithelial photorefractive keratectomy (t-PRK). A total of 119 patients undergoing bilateral t-PRK were divided into three groups: Nepafenac (n = 40), Bromfenac (n = 40), or control (n = 39). Nepafenac 0.1% three times daily or Bromfenac 0.07% twice daily, initiated two days preoperatively and continued for three days postoperatively. The control group received systemic paracetamol (500 mg) and ibuprofen (150 mg) tablets as needed. Overall, both Nepafenac and Bromfenac groups showed significantly lower mean pain levels compared with control group (mean difference = -2.77; 95% CI: -3.63 to - 1.91; p < 0.001, and mean difference = -2.22; 95% CI: -3.01 to -1.43; p < 0.001, respectively). Bromfenac was significantly superior to control only on days 1, 3, and 4. No statistically significant difference in mean pain levels was observed between Bromfenac and Nepafenac groups (mean difference = -0.55; 95% CI: -1.45 to 0.35; p = 0.234). While Nepafenac showed better early symptom control in pain and discomfort (stinging, tearing and light sensitivity), particularly in the first two postoperative days, Bromfenac had a better effect on ocular discomfort in the later postoperative phase on days 4 and 5. Both demonstrated comparable overall tolerability compared to the control. Both Nepafenac and Bromfenac significantly reduced postoperative pain following t-PRK compared to systemic analgesia. These findings support the use of topical NSAIDs in optimizing post-PRK pain management.

PMID 42455136
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PubMedIndian journal of ophthalmology2026-06-30

Comments on "Enhancing presbyopia treatment: A comparative study of 1% Pilocarpine monotherapy versus combination with 0.09% bromfenac".

Singh Sachitanand S, Tripathi Ashith A

PMID 42378084
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PubMedFrontiers in drug delivery2026-06-19

Phosphosulindac (OXT-328) restores the suppressed corneal sensitivity in rabbits with dry eye disease: therapeutic implications.

Huang Wei W, Wen Ziyi Z, Tourmouzis Konstantinos K, Huang Liqun L et al.

The symptoms of dry eye disease (DED) result from activation of ocular sensory nerves and constitute the dominant component of its clinical presentation. We assessed the effect of phosphosulindac (PS), a small molecule efficacious in the treatment of DED in preclinical models, on corneal sensitivity (CS). CS was determined with a Cochet-Bonnet esthesiometer in New Zealand white (NZW) and Dutch-belted black (DBB) rabbits. DED was induced by Concanavalin A injections into the rabbits' lacrimal glands. Changes in CS, tear osmolarity, tear break up time (TBUT) and Schirmer tear test were measured before and after DED induction. PS in various formulations (emulsions, nanoparticles and hydrogels) and other ocular drugs were applied in eye drop form to normal rabbits and those with DED. nduction of DED caused a decrease in the CS, TBUT time as measured by fluorescein dye, in tear production as measured by Schirmer's tear test and an increase in tear osmolarity. PS markedly restored the suppressed CS in dry eyes. The effect was immediate, fully reversible, lasted ∼26 h and appeared dissociated from its anti-inflammatory properties. The most efficacious formulation was a Carbopol-based hydrogel; cyclodextrin-based and emulsion formulations were also effective. The most optimal dose of PS was 0.2% and the optimal pH was 6.2. None of 7 compounds structurally related to PS affected CS nor did cyclosporine, lifitegrast and artificial tears. PS does not have an anesthetic effect on the cornea. In normal eyes, PS suppressed CS and this effect was concentration-, formulation-, and pH-dependent. Two non-steroidal anti-inflammatory drugs (NSAIDs), ketorolac and bromfenac, and lidocaine suppressed CS in normal but not in dry eyes. PS restores the suppressed CS in dry eyes possiblely by a direct effect on corneal nerves. This effect appears unique to PS, distinct from all tested compounds including the two currently approved drugs for DED. PS, in addition to affecting CS of DED, may improve its symptoms and merits further evaluation for the treatment of DED.

PMID 42317768
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