New twice-daily NSAID targets cataract patients

The Food & Drug Administration recently approved bromfenac ophthalmic solution (Xibrom, ISTA Pharmaceuticals) for the treatment of ocular inflammation following cataract surgery. Bromfenac has been marketed in Japan by Senju Pharmaceuticals. ISTA received marketing rights for the drug in 2002 and intends to make the product commercially available in the United States during the second quarter of 2005.

Jorge Parrales, R.Ph., pharmacist-in-charge at Pharmacy Value in Guttenburg, N.J, explained that bromfenac is a topical nonsteroidal anti-inflammatory drug (NSAID), which is believed to exert its anti-inflammatory effects by cyclooxygenase-mediated blockade of prostaglandin synthesis. Prostaglandins have been shown in many animal models to be mediators of certain types of intraocular inflammation, he said.

Bromfenac ophthalmic solution was evaluated in two pivotal phase III clinical studies in the United States. In these clinical trials, patients who had cataract surgery were given either bromfenac or placebo eyedrops two times daily for 14 days, beginning the day after surgery. The study results demonstrated that a statistically significant number of patients receiving bromfenac achieved treatment success, defined as the complete absence of ocular inflammation. A noteworthy study finding was that the beneficial effects of the NSAID were evident by the third day of treatment.

In clinical trials, the most commonly reported adverse events associated with bromfenac therapy included abnormal sensation in the eye, iritis, eye irritation, and pain, said Parrales. The incidence of most of these side effects, however, was low.

According to the manufacturer, bromfenac should be used with caution in individuals who have previously exhibited sensitivities to other NSAIDs, acetylsalicylic acid, and phenylacetic acid derivatives, because of the potential for cross-sensitivity to these drugs. In addition, ISTA advises that the agent be used with caution in patients with known bleeding tendencies or those who are receiving other medications that may prolong bleeding time.

With NSAID therapy, the potential for increased bleeding time exists due to interference with platelet aggregation, explained Parrales. He emphasized that pharmacists should be aware of these recommendations and ensure that patients receive appropriate counseling prior to starting bromfenac therapy.