Manufacturer:

ISTA Pharmaceuticals

Pharmacological Class:

NSAID.

Active Ingredient(s):

Bromfenac 0.09%, oph soln; contains benzalkonium chloride, sulfites.

Indication(s):

Post-operative inflammation and reduction of ocular pain following cataract extraction.

Pharmacology:

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

Clinical Trials:

Clinical efficacy was evaluated in three, randomized, double-masked, placebo-controlled trials in which patients requiring cataract surgery were assigned to Bromday or placebo. Patients were dosed with one drop per eye starting the day before surgery and continuing for 14 days. The primary endpoint was clearing of ocular inflammation by day 15. An additional efficacy endpoint was the number of patients who were pain free on day 1 after cataract surgery.

In two of the three studies, Bromday ophthalmic solution had statistically significant higher incidence of completely clearing inflammation (46–47% vs. 25–29%) and also had a statisitically signficant higher incidence of subjects that were pain free at day 1 post cataract surgery (83–89% vs. 51–71%).

Legal Classification:

Rx

Adults:

≥18yrs: 1 drop in affected eye(s) once daily starting 1 day before surgery, continued on day of surgery, and for 14 days post-op. May be given with other topical ophthalmics (eg, alpha-agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, mydriatics); administer at least 5 minutes apart.

Children:

<18yrs: not recommended.

Warnings/Precautions:

Bleeding tendencies. May slow or delay wound healing. Complicated/repeat ocular surgeries. Corneal defects/denervation. Ocular surface diseases. Rheumatoid arthritis. Diabetes. Monitor cornea; discontinue if corneal epithelial breakdown occurs. Risk of corneal adverse events may be increased if used >24hrs before surgery, or beyond 14-days post-op. Contact lenses (remove during therapy). Pregnancy (Cat.C; avoid during late pregnancy). Nursing mothers.

Interaction(s):

Concomitant topical corticosteroids may potentiate healing problems. Caution with concomitant drugs that prolong bleeding time.

Adverse Reaction(s):

Ocular effects (eg, abnormal sensation, conjunctival hyperemia, burning, stinging, pain, pruritus, redness, iritis), headache; keratitis, corneal reactions (eg, epithelial breakdown, thinning, erosion, ulceration/perforation).

How Supplied:

Soln—1.7mL

Last Updated:

11/18/2010