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Phase 3 study of once-daily NSAID meets primary, secondary endpoints
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FORT LAUDERDALE, Fla. — The second of two phase 3 studies of a once-daily nonsteroidal anti-inflammatory product for the treatment of ocular inflammation and pain following cataract surgery met primary and secondary efficacy endpoints, according to a poster presentation at the Association for Research in Vision and Ophthalmology meeting.
The study produced results similar to those in the independent first trial of Prolensa (bromfenac ophthalmic solution, Ista Pharmaceuticals), announced in April at the American Society of Cataract and Refractive Surgery meeting in Chicago.
As with the first multicenter, randomized, double-masked, parallel-group study, 220 patients who underwent cataract surgery in one eye were enrolled. Subjects received either bromfenac or placebo once daily.
The study determined that a significantly larger proportion of those in the bromfenac group achieved a summed ocular inflammation score of zero by day 15 compared with the placebo group (P < .05). In addition, bromfenac subjects were considered pain-free at postop days 1, 3, 8 and 15 at a higher rate than placebo subjects (P < .005).
Adverse effects were less common in the bromfenac group (P < .005).
Based on the results, Ista will file a new drug application with the U.S. Food and Drug Administration within the next quarter, according to a press release from the company.