ABOUT Bromsite

Defend against ocular pain and treat inflammation with the penetrating power of BromSite formulated with the DuraSite® delivery system1

BromSite is the first and only topical NSAID indicated to prevent ocular pain after cataract surgery.1 Formulated with the DuraSite® delivery system to increase ocular retention time, complete coverage is ensured with twice daily dosing.1,2,3,4,5

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.1

BromSite — the proven power of bromfenac with the DuraSite® delivery system 6,7,8,9

Nepafenac is a prodrug that is converted to amfenac by ocular hydrolases6,10

Bromfenac is an active molecule that is designed for improved corneal penetration6,7,8,9

  • Bromine enhances lipophilicity and tissue penetration
  • In animal studies, bromfenac was detected in the ocular tissues at higher concentrations and for longer than nepafenac
The patented DuraSite® delivery system is viscous and mucoadhesive, and increases retention time on the ocular surface3

Ophthalmic NSAIDs are effective for pain and inflammation6,11

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 (continued)

  • 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.

See additional Important Safety Information below.

DuraSite® delivery system increases ocular retention to help reduce ophthalmic drug loss3

Ophthalmic formulations have a limited ability to reach target tissue.12

Up to 99% of drug
either spills onto the cheek or is drained via the nasolacrimal duct12

Only 1% to 7% of drug actually reaches the aqueous humor12

DuraSite® delivery system increases retention time on the ocular surface, resulting in increased absorption of bromfenac2,3,4,5

The DuraSite® polymer enhances viscosity to increase ocular retention time and reduce medication loss due to blinking and tearing. As DuraSite® mixes with the tear film, the polymer matrix releases bromfenac, which rapidly diffuses across the cornea.3,5 The extended release results in improved absorption of bromfenac.3

BromSite (bromfenac ophthalmic solution) 0.075% is the FIRST and ONLY topical ophthalmic nonsteroidal anti-inflammatory drug (NSAID) indicated to prevent ocular pain after cataract surgery.1






scroll to learn more

Dosage and administration

BromSite combines the proven power of bromfenac with the DuraSite® delivery system to help control inflammation and prevent ocular pain throughout treatment1,6,7,8,9

BromSite (bromfenac ophthalmic solution) 0.075% is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.1

BromSite is administered as 1 drop in the affected eye twice daily, starting one day prior to surgery, the day of surgery, and continuing 14 days postsurgery.1

BromSite provides 24-hour coverage with BID dosing.

BromSite is available in a 5 mL bottle to ensure adequate medication over the dosing schedule.1

BromSite may be used concomitantly with other ophthalmic medications.1 Patients should be advised to administer BromSite at least 5 minutes after instillation of other topical ophthalmic medications.1 Contact lenses should not be worn during treatment with BromSite.1 The preservative in BromSite, benzalkonium chloride, may be absorbed by soft contact lenses.1

All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including BromSite (bromfenac ophthalmic solution) 0.075%, 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.1

Patient Instructions for Use

Download patient step-by-step instructions for how to use BromSite.

 Download here




scroll to learn more

Clinical Trial and Safety Data

In 2 multicenter, double-blind, placebo-controlled studies, subjects requiring cataract surgery were randomized 2:1 to receive BromSite vs vehicle (placebo). Patients were instructed to self-administer BromSite or vehicle twice daily, beginning one day prior to surgery, on the day of surgery, and for 14 days following surgery. Clearance of ocular inflammation was assessed on Days 1, 8, 15, and 29 using slit lamp biomicroscopy.1,13

The primary endpoint evaluated the proportion of patients with anterior chamber cell (ACC) grade 0 on Day 15. Secondary endpoints included: 1) the proportion of patients with anterior chamber flare (ACF) grade, or inflammation score, of 0 at Day 15, and 2) the proportion of patients with visual analog scale (VAS) pain score of 0 on a scale of 0-100 mm at each postsurgical assessment.

BromSite is the only topical NSAID indicated to prevent ocular pain in cataract surgery patients1

Nearly 80% of patients treated with BromSite (vs 55% for vehicle) were pain-free at Day 1 postsurgery.13

Proportion of patients with VAS score 0 (%)

BromSite offers consistent and lasting reductions in postoperative inflammation1

Significantly more patients were anterior chamber cell grade 0, or inflammation-free, on Day 15 using BromSite vs vehicle.1

BromSite™ works over time to reduce inflammation1

BromSite™ was shown to reduce inflammation as early as Day 8 and through Day 29 post cataract surgery.1,13 Patients received BromSite™ up to Day 15.

BromSite demonstrated a superior reduction in postoperative inflammation13

More than 83% of patients had no inflammation on Day 15 with BromSite (vs 45% for vehicle) by anterior chamber flare (ACF).

Secondary endpoint: inflammation-free at Day 15 (ACF)
Integrated analysis

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.1

Treatment-emergent AEs with BromSite were classified as mild or moderate in 93% of patients who experienced them.13

Click here for additional Important Safety Information for BromSite.



scroll to learn more

Contact Us

Do you have questions about BromSite™? At Sun Ophthalmics,
we are dedicated to getting to know you and your practice. Our
highly knowledgeable team can offer you support at every turn.

For reporting adverse drug events (ADEs) related to Sun Pharma products,
please contact 1-800-818-4555 and choose Option 3.

All fields are required.