Bromfenac

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2.

• Bromfenac Ophthalmic Solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction (1) .

• None.contraindicated

Instill one drop into the affected eye once daily beginning 1 day prior to surgery, continued on the day of surgery and through the first 14 days post-surgery (2.1) . 2.1 Recommended Dosing For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of bromfenac ophthalmic solution should be applied to the affected eye once daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 14 days of the postoperative period. 2.2 Use with Other Topical Ophthalmic Medications Bromfenac ophthalmic solution may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.

Sulfite Allergic Reactions (5.1) Slow or Delayed Healing (5.2) Potential for cross-sensitivity (5.3) Increase bleeding of ocular tissues (5.4) Corneal effects including keratitis (5.5) Contact Lens Wear (5.6) 5.1 Sulfite Allergic Reactions Contains sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. 5.2 Slow or Delayed Healing All topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. 5.3 Potential for Cross-Sensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs. 5.4 Increased Bleeding Time With some NSAIDs, there exists the potential for increased bleeding time due to interference with platelet aggregation. There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.

The most commonly reported adverse reactions in 2-7% of patients were abnormal sensation in eye, conjunctival hyperemia and eye irritation (including burning/stinging) (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact Sentiss at 1-855-473-6847 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience The most commonly reported adverse experiences reported following use of bromfenac after cataract surgery include: abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache, and iritis. These events were reported in 2-7% of patients. 6.2 Post-Marketing Experience The following events have been identified during post-marketing use of bromfenac ophthalmic solution 0.09% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical bromfenac ophthalmic solution 0.09% or a combination of these factors, include corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown. [see Warnings and Precautions (5) ]

8.1 Pregnancy Teratogenic Effects Pregnancy Category C Reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (1300 times the recommended human ophthalmic dose [RHOD]) and in rabbits at oral doses up to 7.5 mg/kg/day (11,000 times RHOD) revealed no evidence of teratogenicity due to bromfenac. However, 0.9 mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. Pregnant rabbits treated with 7.5 mg/kg/day caused increased post-implantation loss. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac ophthalmic solution during late pregnancy should be avoided. 8.3 Nursing Mothers Caution should be exercised when bromfenac is administered to a nursing woman. 8.4 Pediatric Use Safety and efficacy in pediatric patients below the age of 18 have not been established.

Metabolism

The plasma concentration of bromfenac following ocular administration of Bromfenac Ophthalmic Solution 0.09% in humans is unknown. Based on the maximum proposed dose of one drop to the eye (0.045 mg) and PK information from other routes of administration, the systemic concentration of bromfenac is estimated to be below the limit of quantification (50 ng/mL) at steady-state in humans.

• Apr 5, 2013NDANDA203168Bausch And Lomb
• Jan 22, 2014ANDAANDA203395Sentiss
• Apr 8, 2016NDANDA206911Sun Pharm
• Jun 21, 2019ANDAANDA210560Alembic
• Mar 17, 2020ANDAANDA211029Gland
• Mar 18, 2022ANDAANDA204813Eugia Pharma
• Aug 15, 2023ANDAANDA202903Lupin
• Nov 22, 2023ANDAANDA206027Lupin

1. 1Off Label Use174—
2. 2Eye Pain168—
3. 3Treatment Failure152—
4. 4Eye Irritation147—
5. 5Vision Blurred124—
6. 6Drug Ineffective116—
7. 7Cataract103—
8. 8Product Dose Omission Issue99—
9. 9Fatigue85—
10. 10Product Packaging Quantity Issue84—
11. 11Dizziness75—
12. 12Headache74—
13. 13Visual Impairment73—
14. 14Nausea67—
15. 15Ocular Hyperaemia62—

The 10 most recently updated of 69 ClinicalTrials.gov registrations naming Bromfenac as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery
  Completed · Phase 4 · Interventional · 50 enrolled · Nicole Fram M.D.
  NCT05626478updated 2026-02-20
• Comparing Efficacy of Bromfenac 0.09%, Nepafenac 0.3% and Diclofenac 0.1% in Patients After Cataract Surgery
  Recruiting · Interventional · 150 enrolled · Nemocnice Kolín
  NCT07178639updated 2025-09-17
• Comparing Post-intravitreal Injection Pain Scores Using Loteprednol, Bromfenac Sodium, and Artificial Tears Over a 24-hour Period
  Completed · Phase 4 · Interventional · 77 enrolled · Retina Research Institute, LLC
  NCT07090044updated 2025-07-29
• Bromfenac Versus Dexamethasone After Cataract Surgery
  Completed · Phase 4 · Interventional · 92 enrolled · Azienda USL Reggio Emilia - IRCCS
  NCT03317847updated 2025-06-25
• Bromfenac to Reduce Inflammation in Patients With Pseudoexfoliation Syndrome After Cataract Surgery
  Completed · Phase 4 · Interventional · 62 enrolled · Azienda USL Reggio Emilia - IRCCS
  NCT02137161updated 2025-06-11
• Effects of Bromfenac on Macular Thickness After Phacoemulsification Surgery
  Completed · Phase 4 · Interventional · 87 enrolled · Inas Abd
  NCT06785090updated 2025-05-06
• Effectiveness of Periocular Drug Injection in CATaract Surgery
  Terminated · Phase 3 · Interventional · 628 enrolled · Luigi Rondas
  NCT05158699updated 2024-11-04
• Pain Reduction With Topical Bromfenac Versus Artificial Tear After Intravitreal Injection.
  Completed · Phase 4 · Interventional · 97 enrolled · Wills Eye
  NCT06130384updated 2024-02-09
• Bromfenac Sodium Hydrate Eye Drops in Familial Exudative Vitreoretinopathy
  Unknown · Phase 2 · Interventional · 39 enrolled · Seoul National University Hospital
  NCT05107921updated 2023-11-22
• Control of Pain in Intravitreal Injections Using Topical NSAIDs
  Completed · Phase 4 · Interventional · 46 enrolled · University of Wisconsin, Madison
  NCT04343222updated 2023-06-12

Frequently asked questions

How does Bromfenac work?

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2.

What is Bromfenac used for?

According to FDA labeling, Bromfenac carries indications including: Bromfenac Ophthalmic Solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction (1) .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Bromfenac?

Bromfenac is classified as Antiinflammatory agents, non-steroids, Nonsteroidal Anti-inflammatory Drug, Cyclooxygenase Inhibitors, Decreased Platelet Aggregation, Decreased Prostaglandin Production.

What are the brand names for Bromfenac?

Bromfenac is marketed under brand names including Bromsite, Prolensa.

What are the contraindications for Bromfenac?

Bromfenac labeling lists contraindications including: None.. Always consult the full prescribing information and a clinician.