FDA approves Prolensa for pain, inflammation after cataract surgery

The U.S. Food and Drug Administration approved Bausch + Lomb’s new drug application for bromfenac ophthalmic solution, according to a company news release.

Prolensa (bromfenac ophthalmic solution 0.07%), a once-daily topical NSAID, is designed for the treatment of ocular inflammation and reduction of ocular pain after cataract surgery.

In two randomized, double-masked, vehicle-controlled trials, Prolensa demonstrated superiority to vehicle in the treatment of pain and inflammation after cataract surgery.

Complete clearance of inflammation by 15 days postop was seen in 46% of patients who received Prolensa compared with 20% of patients who received vehicle. In addition, 78.8% of patients who received Prolensa were pain free at day 1 postop, compared with 49.5% of patients who received vehicle.

The most common adverse reactions, which affected 3% to 8% of patients, were anterior chamber inflammation, foreign body sensation, eye pain, photophobia and blurred vision.

Prolensa will be available in 1.6 mL and 3 mL bottle sizes. The solution will not require shaking to deliver a consistent dosage, according to the release. The recommended dosage is one drop in the affected eye from the day before surgery to 14 days after surgery.