Icon Molecule Structure

BromSite® - Proven power of bromfenac with the DuraSite® delivery system

Nepafenac is a prodrug that is converted to amfenac by ocular hydrolases.2,3

Bromfenac is an active molecule that is designed for improved corneal penetration.2,4,5

  • Bromine enhances lipophilicity and tissue penetration

The patented DuraSite® delivery system is viscous and mucoadhesive, and increases retention time on the ocular surface.6,7

Ophthalmic drug loss
Ophthalmic drug loss

DuraSite® increases retention time on the ocular surface, resulting in increased absorption of bromfenac6,7,9,10

BromSite® on the ocular surface

DuraSite® enhances viscosity to increase ocular retention time. Bromfenac is sequestered within the DuraSite® delivery system6,7

Bromfenac release

After mixing with the tear film, DuraSite® releases bromfenac, which diffuses across the cornea6,7

Important Safety Information

Indications and Usage

BromSite® (bromfenac ophthalmic solution) 0.075% is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.

Important Safety Information

  • Slow or Delayed Healing: All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including BromSite®, 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.
  • Potential for Cross-Sensitivity: There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including BromSite®. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs. Increased
  • Increased Bleeding Time of Ocular Tissue: With some NSAIDs, including BromSite®, 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. It is recommended that BromSite® be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
  • Keratitis and Corneal Effects: Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including BromSite®, and should be closely monitored for corneal health. Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Post-marketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days postsurgery may increase patient risk for the occurrence and severity of corneal adverse events.
  • Contact Lens Wear: BromSite® should not be administered while wearing contact lenses. The preservative in BromSite®, benzalkonium chloride, may be absorbed by soft contact lenses.
  • Adverse Reactions: The most commonly reported adverse reactions in 1% to 8% of patients were anterior chamber inflammation, headache, vitreous floaters, iritis, eye pain, and ocular hypertension.

Please see the Full Prescribing Information.

Indications and Usage

BromSite® (bromfenac ophthalmic solution) 0.075% is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.

Important Safety Information

Indications and Usage

BromSite® (bromfenac ophthalmic solution) 0.075% is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.

Important Safety Information

  • Slow or Delayed Healing: All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including BromSite®, 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.
  • Potential for Cross-Sensitivity: There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including BromSite®. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs. Increased
  • Increased Bleeding Time of Ocular Tissue: With some NSAIDs, including BromSite®, 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. It is recommended that BromSite® be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
  • Keratitis and Corneal Effects: Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including BromSite®, and should be closely monitored for corneal health. Patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Post-marketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days postsurgery may increase patient risk for the occurrence and severity of corneal adverse events.
  • Contact Lens Wear: BromSite® should not be administered while wearing contact lenses. The preservative in BromSite®, benzalkonium chloride, may be absorbed by soft contact lenses.
  • Adverse Reactions: The most commonly reported adverse reactions in 1% to 8% of patients were anterior chamber inflammation, headache, vitreous floaters, iritis, eye pain, and ocular hypertension.

Please see the Full Prescribing Information.

References: 1. BromSite® [package insert]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; 2016. 2. Cho H, Wolf KJ, Wolf EJ. Management of ocular inflammation and pain following cataract surgery: focus on bromfenac ophthalmic solution. Clin Ophthalmol. 2009;3:199-210. 3. Ilevro [package insert]. Fort Worth, TX: Alcon Laboratories, Inc.; 2014. 4. Ahuja M, Dhake AS, Sharma SK, et al. Topical ocular delivery of NSAIDs. AAPS J. 2008;10(2):229-241. 5. Baklayan GA, Muñoz M. The ocular distribution of 14C-labeled bromfenac ophthalmic solution 0.07% in a rabbit model. Clin Ophthalmol. 2014;8:1717-1724. 6. Bowman LM, Si E, Pang J, et al. Development of a topical polymeric mucoadhesive ocular delivery system for azithromycin. J Ocul Pharmacol Ther. 2009;25(2):133-139. 7. Hosseini K, Bowman L, Si EC, Pham S, inventors; InSite Vision Incorporated, assignee. Non-steroidal anti-inflammatory ophthalmic compositions. US patent 8,778,999 B2. July 15, 2014. 8. Ghate D, Edelhauser HF. Ocular drug delivery. Expert Opin Drug Deliv. 2006;3(2):275-287. 9. Walters TR, Smyth-Medina RJ, Cockrum PC. An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations. Clin Ophthalmol. 2018;12:943-947. 10. Si EC, Bowman LM, Hosseini K. Pharmacokinetic comparisons of bromfenac in DuraSite and Xibrom. J Ocul Pharmacol Ther. 2011;27(1):61-66.