Bromday®

Bromfenac 0.09% · ophthalmic solution

NSAID

Approved uses

Postoperative inflammation and ocular pain after cataract surgery

One drop QD to the affected eye(s) starting 1 day before surgery, on the day of surgery, and through the first 14 days postoperatively.

Pain-free rates beat placebo from day 1, with inflammation cleared by day 15.

OFF-LABELNot in the FDA label for this product

Cystoid macular edema prophylaxis after cataract surgery

Bromfenac 0.09% one drop BID for 2 weeks, alone or with dexamethasone 0.1% QID tapering by one drop per day each following week.

RCT · n=914 · combo only

ESCRS PREMED, a randomized multicenter trial in 914 nondiabetic patients, compared 0.09% BID, dexamethasone 0.1%, and the two combined. Clinically significant macular edema within 12 weeks occurred in 3.6% with the NSAID alone, 5.1% with the steroid alone, and 1.5% with the combination (overall P = .043), and the authors concluded that the combination, not either drug alone, lowered the risk.

Wielders LHP, Schouten JSAG, Winkens B, et al. European multicenter trial of the prevention of cystoid macular edema after cataract surgery in nondiabetics: ESCRS PREMED study report 1. J Cataract Refract Surg. 2018;44(4):429-439.

Ocular pain and discomfort after photorefractive keratectomy

Bromfenac 0.09% one drop BID postoperatively, applied after a bandage contact lens was fitted; the report states no total duration.

Open-label RCT · n=212 eyes

Open-label randomized trial in 212 eyes found no significant difference between 0.09% BID and ketorolac 0.4% QID in postoperative pain, burning, foreign body sensation, or photophobia, and no difference in epithelial healing rates. A smaller double-masked randomized trial (29 patients, 58 eyes) dosing every agent TID found slower mean reepithelialization on bromfenac 0.09%, 7.25 days versus 5.50 days for nepafenac 0.1% and 5.62 days for ketorolac 0.4% (P < .05).

Sher NA, Golben MR, Bond W, Trattler WB, Tauber S, Voirin TG. Topical bromfenac 0.09% vs. ketorolac 0.4% for the control of pain, photophobia, and discomfort following PRK. J Refract Surg. 2009;25(2):214-220; and Durrie DS, Kennard MG, Boghossian AJ. Effects of nonsteroidal ophthalmic drops on epithelial healing and pain in patients undergoing bilateral photorefractive keratectomy (PRK). Adv Ther. 2007;24(6):1278-1285.

Contraindications

None listed on the FDA label.

Available Forms

0.09% ophthalmic solution, 1.7 mL dropper bottle

Mechanism of Action

Nonsteroidal anti-inflammatory drug that blocks prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2. Prostaglandins mediate intraocular inflammation, disrupting the blood-aqueous barrier and producing vasodilation, increased vascular permeability, leukocytosis, and raised intraocular pressure in animal eyes.

Warnings & Precautions

Keratitis and corneal reactions: Topical NSAIDs may cause keratitis, and continued use in susceptible patients may progress to epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation, any of which may be sight threatening. Discontinue immediately on evidence of corneal epithelial breakdown and monitor corneal health closely.
Higher-risk corneas: Complicated ocular surgery, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface disease such as dry eye, rheumatoid arthritis, and repeat ocular surgery within a short period raise the risk of sight-threatening corneal events.
Extended perioperative use: Dosing more than 24 hours before surgery or beyond 14 days after surgery may increase the occurrence and severity of corneal adverse events.
Sulfite hypersensitivity: Contains sodium sulfite, which can provoke allergic reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people; sulfite sensitivity is seen more often in asthmatic than in non-asthmatic people.
Delayed healing: All topical NSAIDs may slow or delay healing, and concomitant topical steroids compound the risk.
Cross-sensitivity: Potential cross-reactivity with acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs; use caution in patients who have reacted to these drugs.
Increased bleeding time: NSAIDs can interfere with platelet aggregation, and ocularly applied NSAIDs have been reported to increase bleeding of ocular tissues, including hyphema, in conjunction with ocular surgery. Use caution with known bleeding tendencies or drugs that prolong bleeding time.
Contact lens wear: Not to be administered while wearing contact lenses.

Common Side Effects

Ocular, 2% to 7%: Abnormal sensation in eye, conjunctival hyperemia, eye irritation including burning and stinging, eye pain, eye pruritus, eye redness, iritis.
Systemic, 2% to 7%: Headache.
Ocular, postmarketing: Corneal erosion, corneal thinning, corneal perforation, epithelial breakdown; frequency cannot be estimated.

Pregnancy & Lactation

Pregnancy: No adequate and well-controlled studies in pregnant women (Pregnancy Category C on this label); avoid during late pregnancy because prostaglandin synthesis inhibitors can close the fetal ductus arteriosus. Oral dosing in rats and rabbits showed no teratogenicity, but produced embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth in rats and increased post-implantation loss in rabbits.

Lactation: Exercise caution when administering to a nursing woman.

Pediatric Use

Safety and efficacy below age 18 not established.